Trial Outcomes & Findings for Pazopanib Hydrochloride in Treating Patients With Von Hippel-Lindau Syndrome (NCT NCT01436227)
NCT ID: NCT01436227
Last Updated: 2025-05-02
Results Overview
Overall response rate (complete response + partial response) Determined by the Response Evaluation Criteria in Solid Tumors. Estimated with its corresponding 95% posterior credible interval.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
32 participants
Primary outcome timeframe
At 24 weeks
Results posted on
2025-05-02
Participant Flow
From January 2012 to August 2016, patients were recruited from the outpatient clinics for Genitourinary Medical Oncology at MD Anderson Cancer Center in Houston, Texas who have been diagnosed with Von Hippel-Lindau Syndrome.
32 subject enrolled
Participant milestones
| Measure |
Treatment (Pazopanib Hydrochloride) Patients Receive Pazopanib Hydrochloride PO QD on Days 1-28
Pazopanib 800mg PO Daily
|
|---|---|
|
Overall Study
STARTED
|
32
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
26
|
Reasons for withdrawal
| Measure |
Treatment (Pazopanib Hydrochloride) Patients Receive Pazopanib Hydrochloride PO QD on Days 1-28
Pazopanib 800mg PO Daily
|
|---|---|
|
Overall Study
Adverse Event
|
7
|
|
Overall Study
Death
|
1
|
|
Overall Study
Lack of Efficacy
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Withdrawal by Subject
|
7
|
|
Overall Study
Disease progression, relapse
|
6
|
Baseline Characteristics
Pazopanib Hydrochloride in Treating Patients With Von Hippel-Lindau Syndrome
Baseline characteristics by cohort
| Measure |
Treatment (Pazopanib Hydrochloride) Patients Receive Pazopanib Hydrochloride PO QD on Days 1-28
n=32 Participants
Pazopanib 800mg PO Daily
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
31 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: At 24 weeksOverall response rate (complete response + partial response) Determined by the Response Evaluation Criteria in Solid Tumors. Estimated with its corresponding 95% posterior credible interval.
Outcome measures
| Measure |
Treatment (Pazopanib Hydrochloride) Patients Receive Pazopanib Hydrochloride PO QD on Days 1-28
n=31 Participants
Pazopanib 800mg PO Daily
|
|---|---|
|
Overall Response Rate (Complete Response + Partial Response)
|
13 Participants
|
PRIMARY outcome
Timeframe: Up to 24 weeksProgressive disease rate
Outcome measures
| Measure |
Treatment (Pazopanib Hydrochloride) Patients Receive Pazopanib Hydrochloride PO QD on Days 1-28
n=31 Participants
Pazopanib 800mg PO Daily
|
|---|---|
|
Progressive Disease Rate
|
6 Participants
|
PRIMARY outcome
Timeframe: Up to 24 weeksDrug discontinuation due to toxicity
Outcome measures
| Measure |
Treatment (Pazopanib Hydrochloride) Patients Receive Pazopanib Hydrochloride PO QD on Days 1-28
n=31 Participants
Pazopanib 800mg PO Daily
|
|---|---|
|
Drug Discontinuation Due to Toxicity
|
7 Participants
|
PRIMARY outcome
Timeframe: Up to 24 weeksTTP will be estimated using the Kaplan-Meier method. Log-rank test will be performed to test the difference in survival between prognostic groups. Regression analyses of survival data based on the Cox proportional hazards model will be conducted on TTP. The proportional hazards assumption will be evaluated graphically and analytically, and regression diagnostics (e.g., martingale and Shoenfeld residuals) will be examined to ensure that the models are appropriate.
Outcome measures
| Measure |
Treatment (Pazopanib Hydrochloride) Patients Receive Pazopanib Hydrochloride PO QD on Days 1-28
n=32 Participants
Pazopanib 800mg PO Daily
|
|---|---|
|
Time to Progression (TTP)
|
NA Days
Standard Deviation NA
There is no data to report due to median PFS not being reached.
|
Adverse Events
Treatment (Pazopanib Hydrochloride) Patients Receive Pazopanib Hydrochloride PO QD on Days 1-28
Serious events: 12 serious events
Other events: 32 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Treatment (Pazopanib Hydrochloride) Patients Receive Pazopanib Hydrochloride PO QD on Days 1-28
n=32 participants at risk
Pazopanib 800mg PO Daily
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
3.1%
1/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Investigations
Alanine aminotransferase increased
|
12.5%
4/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Infections and infestations
Appendicitis
|
3.1%
1/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Investigations
Aspartate aminotransferase increased
|
3.1%
1/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Blood and lymphatic system disorders
Blood bilirubin increased
|
3.1%
1/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Gastrointestinal disorders
Gastritis
|
3.1%
1/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
General disorders
General disorders and administration site conditions - Other, Fatigue weakness
|
3.1%
1/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
3.1%
1/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Nervous system disorders
Intracranial hemorrhage
|
6.2%
2/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Nervous system disorders
Nervous system disorders - Other, increased right hand weakness and difficulty performing ADL.
|
3.1%
1/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.1%
1/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Nervous system disorders
Stroke
|
3.1%
1/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
General disorders
Surgical and medical procedures - Other, stereotactic radiosurgery
|
3.1%
1/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
Other adverse events
| Measure |
Treatment (Pazopanib Hydrochloride) Patients Receive Pazopanib Hydrochloride PO QD on Days 1-28
n=32 participants at risk
Pazopanib 800mg PO Daily
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
12.5%
4/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
6.2%
2/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Nervous system disorders
Akathisia
|
3.1%
1/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Investigations
Alanine aminotransferase increased
|
59.4%
19/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Investigations
Alkaline phosphatase increased
|
18.8%
6/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Investigations
Allergic reaction
|
3.1%
1/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
28.1%
9/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Blood and lymphatic system disorders
Anemia
|
31.2%
10/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Metabolism and nutrition disorders
Anorexia
|
15.6%
5/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Psychiatric disorders
Anxiety
|
12.5%
4/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Gastrointestinal disorders
Appendicitis
|
3.1%
1/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.5%
4/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
12.5%
4/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Investigations
Aspartate aminotransferase increased
|
59.4%
19/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Nervous system disorders
Ataxia
|
9.4%
3/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
18.8%
6/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Gastrointestinal disorders
Bloating
|
3.1%
1/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Blood and lymphatic system disorders
Blood bilirubin increased
|
21.9%
7/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Eye disorders
Blurred vision
|
18.8%
6/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Investigations
Cholesterol high
|
6.2%
2/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Gastrointestinal disorders
Colitis
|
3.1%
1/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Nervous system disorders
Concentration impairment
|
3.1%
1/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Nervous system disorders
Confusion
|
3.1%
1/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Gastrointestinal disorders
Constipation
|
18.8%
6/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.1%
1/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Investigations
Creatinine increased
|
28.1%
9/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Psychiatric disorders
Depression
|
34.4%
11/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Gastrointestinal disorders
Diarrhea
|
81.2%
26/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Nervous system disorders
Dizziness
|
15.6%
5/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Gastrointestinal disorders
Dry mouth
|
3.1%
1/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Nervous system disorders
Dysarthria
|
3.1%
1/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Nervous system disorders
Dysesthesia
|
3.1%
1/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Nervous system disorders
Dysgeusia
|
21.9%
7/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.2%
2/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Gastrointestinal disorders
Dysphagia
|
3.1%
1/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
15.6%
5/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
General disorders
Edema limbs
|
6.2%
2/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Endocrine disorders
Endocrine disorders - Other, specify
|
3.1%
1/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
12.5%
4/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Eye disorders
Eye disorders - Other, specify
|
6.2%
2/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
General disorders
Facial nerve disorder
|
6.2%
2/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
General disorders
Facial pain
|
3.1%
1/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
General disorders
Fatigue
|
84.4%
27/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
General disorders
Fever
|
3.1%
1/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
3.1%
1/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Eye disorders
Flashing lights
|
3.1%
1/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Eye disorders
Floaters
|
6.2%
2/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
General disorders
Flu like symptoms
|
3.1%
1/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Injury, poisoning and procedural complications
Fracture
|
3.1%
1/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
General disorders
Gait disturbance
|
3.1%
1/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Gastrointestinal disorders
Gastritis
|
3.1%
1/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
9.4%
3/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
9.4%
3/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
3.1%
1/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
18.8%
6/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Investigations
GGT increased
|
6.2%
2/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
3.1%
1/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Nervous system disorders
Headache
|
43.8%
14/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Ear and labyrinth disorders
Hearing impaired
|
12.5%
4/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Renal and urinary disorders
Hematuria
|
3.1%
1/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Renal and urinary disorders
Hemoglobinuria
|
6.2%
2/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Vascular disorders
Hot flashes
|
6.2%
2/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
3.1%
1/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
71.9%
23/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
6.2%
2/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
9.4%
3/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Vascular disorders
Hypertension
|
53.1%
17/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Endocrine disorders
Hyperthyroidism
|
15.6%
5/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
6.2%
2/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
9.4%
3/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
18.8%
6/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
15.6%
5/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
9.4%
3/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
12.5%
4/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
6.2%
2/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
12.5%
4/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
15.6%
5/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Endocrine disorders
Hypothyroidism
|
3.1%
1/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
General disorders
Immune system disorders - Other, specify
|
3.1%
1/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Psychiatric disorders
Insomnia
|
18.8%
6/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Nervous system disorders
Intracranial hemorrhage
|
3.1%
1/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
General disorders
Investigations - Other, specify
|
9.4%
3/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
General disorders
Irregular menstruation
|
6.2%
2/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
General disorders
Libido decreased
|
3.1%
1/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Investigations
Lipase increased
|
12.5%
4/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
General disorders
Localized edema
|
3.1%
1/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Investigations
Lymphocyte count decreased
|
9.4%
3/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
3.1%
1/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Gastrointestinal disorders
Mucositis oral
|
31.2%
10/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
3.1%
1/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
3.1%
1/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Gastrointestinal disorders
Nausea
|
56.2%
18/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
25.0%
8/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
3.1%
1/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Investigations
Neutrophil count decreased
|
25.0%
8/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Nervous system disorders
Nystagmus
|
6.2%
2/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Eye disorders
Optic nerve disorder
|
9.4%
3/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
General disorders
Pain
|
18.8%
6/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
3.1%
1/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
15.6%
5/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Skin and subcutaneous tissue disorders
Papulopustular rash
|
3.1%
1/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Nervous system disorders
Paresthesia
|
3.1%
1/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Infections and infestations
Penile infection
|
3.1%
1/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
3.1%
1/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
25.0%
8/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Nervous system disorders
Personality change
|
3.1%
1/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Eye disorders
Photophobia
|
3.1%
1/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
3.1%
1/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Investigations
Platelet count decreased
|
21.9%
7/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
3.1%
1/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Renal and urinary disorders
Proteinuria
|
46.9%
15/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.1%
1/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
15.6%
5/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
12.5%
4/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
3.1%
1/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Renal and urinary disorders
Renal colic
|
3.1%
1/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
3.1%
1/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Nervous system disorders
Seizure
|
6.2%
2/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Investigations
Serum amylase increased
|
3.1%
1/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
28.1%
9/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
6.2%
2/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
50.0%
16/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Nervous system disorders
Somnolence
|
3.1%
1/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Gastrointestinal disorders
Stomach pain
|
3.1%
1/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Nervous system disorders
Suicidal ideation
|
3.1%
1/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Ear and labyrinth disorders
Tinnitus
|
18.8%
6/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Renal and urinary disorders
Urinary frequency
|
6.2%
2/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Renal and urinary disorders
Urinary incontinence
|
3.1%
1/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Renal and urinary disorders
Urinary tract infection
|
6.2%
2/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Renal and urinary disorders
Urinary tract pain
|
6.2%
2/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Renal and urinary disorders
Urinary urgency
|
3.1%
1/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Renal and urinary disorders
Vaginal infection
|
3.1%
1/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Renal and urinary disorders
Vaginal inflammation
|
3.1%
1/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Ear and labyrinth disorders
Vertigo
|
3.1%
1/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Ear and labyrinth disorders
Vestibular disorder
|
6.2%
2/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
3.1%
1/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Gastrointestinal disorders
Vomiting
|
31.2%
10/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Eye disorders
Watering eyes
|
3.1%
1/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
General disorders
Weight loss
|
12.5%
4/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
3.1%
1/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
|
Investigations
White blood cell decreased
|
31.2%
10/32 • From first dose until 30 days after last dose of drug, up to 28 weeks.
Death or life-threatening events that place the patient at immediate risk of death (excluding those that could lead to death in a more severe form). Includes inpatient hospitalization, extended hospitalization, significant incapacity, or major disruption of normal life functions. Also includes congenital anomalies or birth defects.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place