Trial Outcomes & Findings for Non-Interventional Study (NIS) In Patients With Advanced And/Or Metastatic Renal Cell Carcinoma (mRCC) Treated With SUTENT® (NCT NCT00684645)
NCT ID: NCT00684645
Last Updated: 2012-08-21
Results Overview
Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR). CR is defined as the disappearance of all target lesions. PR is defined as at least 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
Recruitment status
COMPLETED
Target enrollment
186 participants
Primary outcome timeframe
12 months
Results posted on
2012-08-21
Participant Flow
Participant milestones
| Measure |
Sunitinib
The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
|
|---|---|
|
Overall Study
STARTED
|
186
|
|
Overall Study
COMPLETED
|
72
|
|
Overall Study
NOT COMPLETED
|
114
|
Reasons for withdrawal
| Measure |
Sunitinib
The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
|
|---|---|
|
Overall Study
Death
|
2
|
|
Overall Study
Progressive disease
|
67
|
|
Overall Study
Adverse Event
|
27
|
|
Overall Study
Lost to Follow-up
|
3
|
|
Overall Study
Other
|
15
|
Baseline Characteristics
Non-Interventional Study (NIS) In Patients With Advanced And/Or Metastatic Renal Cell Carcinoma (mRCC) Treated With SUTENT®
Baseline characteristics by cohort
| Measure |
Sunitinib
n=186 Participants
The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
|
|---|---|
|
Age, Customized
18 to 44 years
|
10 participants
n=5 Participants
|
|
Age, Customized
45 to 64 years
|
99 participants
n=5 Participants
|
|
Age, Customized
65 years or more
|
77 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
128 Participants
n=5 Participants
|
|
Involvement of Regional Lymph Nodes
Iliac
|
31 participants
n=5 Participants
|
|
Involvement of Regional Lymph Nodes
Paraaortal
|
25 participants
n=5 Participants
|
|
Involvement of Regional Lymph Nodes
Paracaval
|
6 participants
n=5 Participants
|
|
Previous Anti-Tumor Therapy
Prior Radiotherapy
|
152 participants
n=5 Participants
|
|
Previous Anti-Tumor Therapy
Prior Chemotherapy
|
173 participants
n=5 Participants
|
|
Previous Anti-Tumor Therapy
Prior Hormonal Therapy
|
180 participants
n=5 Participants
|
|
Previous Anti-Tumor Therapy
Prior Immunotherapy
|
35 participants
n=5 Participants
|
|
Previous Anti-Tumor Therapy
Prior Cancer Surgeries
|
8 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
ECOG Performance Status 0
|
23 percentage of participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
ECOG Performance Status 1
|
72 percentage of participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
ECOG Performance Status 2
|
5 percentage of participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
ECOG Performance Status 3
|
0 percentage of participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
ECOG Performance Status 4
|
0 percentage of participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
ECOG Performance Status 5
|
0 percentage of participants
n=5 Participants
|
|
Frequency of Involved Disease Sites
Adrenal
|
5 participants
n=5 Participants
|
|
Frequency of Involved Disease Sites
Bone
|
32 participants
n=5 Participants
|
|
Frequency of Involved Disease Sites
Chest wall
|
1 participants
n=5 Participants
|
|
Frequency of Involved Disease Sites
Kidney
|
26 participants
n=5 Participants
|
|
Frequency of Involved Disease Sites
Liver
|
20 participants
n=5 Participants
|
|
Frequency of Involved Disease Sites
Lung
|
88 participants
n=5 Participants
|
|
Frequency of Involved Disease Sites
Lymph node
|
7 participants
n=5 Participants
|
|
Frequency of Involved Disease Sites
Lymph node - Mediastinum
|
13 participants
n=5 Participants
|
|
Frequency of Involved Disease Sites
Lymph node - Other
|
4 participants
n=5 Participants
|
|
Frequency of Involved Disease Sites
Lymph node - Retroperitoneal
|
12 participants
n=5 Participants
|
|
Frequency of Involved Disease Sites
Lymph node - Supraclavicular
|
2 participants
n=5 Participants
|
|
Frequency of Involved Disease Sites
Lymph node - Regional
|
2 participants
n=5 Participants
|
|
Frequency of Involved Disease Sites
Mediastinum
|
3 participants
n=5 Participants
|
|
Frequency of Involved Disease Sites
Other
|
13 participants
n=5 Participants
|
|
Frequency of Involved Disease Sites
Pancreas
|
4 participants
n=5 Participants
|
|
Frequency of Involved Disease Sites
Pelvis
|
1 participants
n=5 Participants
|
|
Frequency of Involved Disease Sites
Peritoneum
|
7 participants
n=5 Participants
|
|
Frequency of Involved Disease Sites
Pleura
|
1 participants
n=5 Participants
|
|
Frequency of Involved Disease Sites
Skin
|
1 participants
n=5 Participants
|
|
Frequency of Involved Disease Sites
Spleen
|
1 participants
n=5 Participants
|
|
Prevalence of hypothyroidism
Hypothyroidism present
|
15 participants
n=5 Participants
|
|
Prevalence of hypothyroidism
Hypothyroidism absent
|
171 participants
n=5 Participants
|
|
Prevalence of Hypertension
Hypertension present
|
119 participants
n=5 Participants
|
|
Prevalence of Hypertension
Hypertension absent
|
67 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Full analysis set (FAS): all participants who received at least one dose of the study medication.
Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR). CR is defined as the disappearance of all target lesions. PR is defined as at least 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
Outcome measures
| Measure |
Sunitinib
n=186 Participants
The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
|
|---|---|
|
Percentage of Participants With Objective Response
|
25.3 percentage of participants
Interval 19.2 to 32.1
|
PRIMARY outcome
Timeframe: Baseline to measured progressive disease (up to 12 months)Population: FAS
The period from study entry until disease progression, death, or date of last contact.
Outcome measures
| Measure |
Sunitinib
n=186 Participants
The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
|
|---|---|
|
Progression-free Survival (PFS)
|
9.8 months
Interval 9.1 to 12.5
|
PRIMARY outcome
Timeframe: Baseline to date of death (up to 12 months)Population: FAS
OS is the duration from enrollment to death.
Outcome measures
| Measure |
Sunitinib
n=186 Participants
The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
|
|---|---|
|
Overall Survival (OS)
|
NA months
NA=not available. No median available, very few deaths observed.
|
PRIMARY outcome
Timeframe: Week 6Population: FAS. Percentages based on entire FAS population.
Following are ECOG grades. 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of selfcare, unable to carry out any work activities, up and about more than (\>) 50% of waking hours. 3: Capable of limited selfcare, confined to bed or chair \>50% of waking hours. 4: Completely disabled, not capable of any selfcare, totally confined to bed or chair. 5: Dead. Participants in "Not reported" category were on study, had no data for this time point.
Outcome measures
| Measure |
Sunitinib
n=186 Participants
The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
|
|---|---|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Week 6
ECOG Grade 0
|
18.8 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Week 6
ECOG Grade 1
|
68.3 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Week 6
ECOG Grade 2
|
8.6 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Week 6
ECOG Grade 3
|
2.2 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Week 6
ECOG Grade 4
|
0.0 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Week 6
ECOG Grade 5
|
0.0 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Week 6
Not Reported
|
2.2 percentage of participants
|
PRIMARY outcome
Timeframe: Month 3Population: FAS. Percentages based on entire FAS population.
Following are ECOG grades. 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of selfcare, unable to carry out any work activities, up and about more than (\>) 50% of waking hours. 3: Capable of limited selfcare, confined to bed or chair \>50% of waking hours. 4: Completely disabled, not capable of any selfcare, totally confined to bed or chair. 5: Dead. Participants in "Not reported" category were on study, had no data for this time point.
Outcome measures
| Measure |
Sunitinib
n=186 Participants
The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
|
|---|---|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Month 3
ECOG Grade 0
|
16.7 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Month 3
ECOG Grade 1
|
60.2 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Month 3
ECOG Grade 2
|
10.2 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Month 3
ECOG Grade 3
|
2.7 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Month 3
ECOG Grade 4
|
0.0 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Month 3
ECOG Grade 5
|
0.0 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Month 3
Not Reported
|
10.2 percentage of participants
|
PRIMARY outcome
Timeframe: Month 6Population: FAS. Percentages based on entire FAS population.
Following are ECOG grades. 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of selfcare, unable to carry out any work activities, up and about more than (\>) 50% of waking hours. 3: Capable of limited selfcare, confined to bed or chair \>50% of waking hours. 4: Completely disabled, not capable of any selfcare, totally confined to bed or chair. 5: Dead. Participants in "Not reported" category were on study, had no data for this time point.
Outcome measures
| Measure |
Sunitinib
n=186 Participants
The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
|
|---|---|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Month 6
ECOG Grade 0
|
14.5 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Month 6
ECOG Grade 1
|
47.8 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Month 6
ECOG Grade 2
|
4.3 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Month 6
ECOG Grade 3
|
1.6 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Month 6
ECOG Grade 4
|
1.1 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Month 6
ECOG Grade 5
|
0.0 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Month 6
Not Reported
|
30.6 percentage of participants
|
PRIMARY outcome
Timeframe: Month 9Population: FAS. Percentages based on entire FAS population.
Following are ECOG grades. 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of selfcare, unable to carry out any work activities, up and about more than (\>) 50% of waking hours. 3: Capable of limited selfcare, confined to bed or chair \>50% of waking hours. 4: Completely disabled, not capable of any selfcare, totally confined to bed or chair. 5: Dead. Participants in "Not reported" category were on study, had no data for this time point.
Outcome measures
| Measure |
Sunitinib
n=186 Participants
The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
|
|---|---|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Month 9
ECOG Grade 0
|
11.8 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Month 9
ECOG Grade 1
|
36.6 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Month 9
ECOG Grade 2
|
4.8 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Month 9
ECOG Grade 3
|
0.5 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Month 9
ECOG Grade 4
|
0.0 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Month 9
ECOG Grade 5
|
0.0 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Month 9
Not Reported
|
46.2 percentage of participants
|
PRIMARY outcome
Timeframe: Month 12Population: FAS. Percentages based on entire FAS population.
Following are ECOG grades. 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of selfcare, unable to carry out any work activities, up and about more than (\>) 50% of waking hours. 3: Capable of limited selfcare, confined to bed or chair \>50% of waking hours. 4: Completely disabled, not capable of any selfcare, totally confined to bed or chair. 5: Dead. Participants in "Not reported" category were on study, had no data for this time point.
Outcome measures
| Measure |
Sunitinib
n=186 Participants
The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
|
|---|---|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Month 12
ECOG Grade 0
|
15.1 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Month 12
ECOG Grade 1
|
39.8 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Month 12
ECOG Grade 2
|
8.1 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Month 12
ECOG Grade 3
|
4.8 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Month 12
ECOG Grade 4
|
0.5 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Month 12
ECOG Grade 5
|
1.1 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Month 12
Not Reported
|
30.6 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline to date of first documentation of response to treatment (up to 12 months)Population: FAS
Sunitinib-induced hypertension was determined using blood pressure recorded at each postbaseline visit. Once participants were identified as having sunitinib-induced hypertension, they retained that status at subsequent visits. PFS is the time from start of study treatment to first documentation of tumor response to treatment. Hazard ratio represents the relationship between sunitinib-induced hypertension and PFS (presence/absence of hypertension).
Outcome measures
| Measure |
Sunitinib
n=186 Participants
The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
|
|---|---|
|
Correlation Between Sunitinib-induced Hypertension and Tumor Response to Treatment (PFS)
Sunitinib-induced hypertension starting at Week 6
|
39 participants
Interval 0.257 to 0.609
|
|
Correlation Between Sunitinib-induced Hypertension and Tumor Response to Treatment (PFS)
Sunitinib-induced hypertension starting at Month 3
|
16 participants
|
|
Correlation Between Sunitinib-induced Hypertension and Tumor Response to Treatment (PFS)
Sunitinib-induced hypertension starting at Month 6
|
11 participants
|
|
Correlation Between Sunitinib-induced Hypertension and Tumor Response to Treatment (PFS)
Sunitinib-induced hypertension starting at Month 9
|
12 participants
|
|
Correlation Between Sunitinib-induced Hypertension and Tumor Response to Treatment (PFS)
Sunitinib-induced hypertension starting Month 12
|
4 participants
|
PRIMARY outcome
Timeframe: Baseline to date of death (up to 12 months)Population: FAS
Sunitinib-induced hypertension was determined using blood pressure recorded at each postbaseline visit. Once participants were identified as having sunitinib-induced hypertension, they retained that status at subsequent visits. OS is the time from start of study treatment to death. Hazard ratio represents the relationship between sunitinib-induced hypertension and OS.
Outcome measures
| Measure |
Sunitinib
n=186 Participants
The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
|
|---|---|
|
Correlation Between Sunitinib-induced Hypertension and Tumor Response to Treatment (OS)
Sunitinib-induced hypertension starting at Week 6
|
39 participants
Interval 0.151 to 0.864
|
|
Correlation Between Sunitinib-induced Hypertension and Tumor Response to Treatment (OS)
Sunitinib-induced hypertension starting at Month 3
|
16 participants
|
|
Correlation Between Sunitinib-induced Hypertension and Tumor Response to Treatment (OS)
Sunitinib-induced hypertension starting at Month 6
|
11 participants
|
|
Correlation Between Sunitinib-induced Hypertension and Tumor Response to Treatment (OS)
Sunitinib-induced hypertension starting at Month 9
|
12 participants
|
|
Correlation Between Sunitinib-induced Hypertension and Tumor Response to Treatment (OS)
Sunitinib-induced hypertension starting Month 12
|
4 participants
|
PRIMARY outcome
Timeframe: Baseline, Months 3, 6, 9, 12Population: FAS. n = number of participants with evaluable data at that time point.
TSH and FT4 levels were measured and hypothyroidism was defined as a TSH level \>5.0 mIU/L at that time point.
Outcome measures
| Measure |
Sunitinib
n=186 Participants
The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
|
|---|---|
|
Percentage of Participants With Hypothyroidism
Baseline (n=186)
|
8.1 percentage of participants
|
|
Percentage of Participants With Hypothyroidism
Month 3 (n=168)
|
17.9 percentage of participants
|
|
Percentage of Participants With Hypothyroidism
Month 6 (n=131)
|
18.3 percentage of participants
|
|
Percentage of Participants With Hypothyroidism
Month 9 (n=100)
|
20.0 percentage of participants
|
|
Percentage of Participants With Hypothyroidism
Month 12 (n=134)
|
20.9 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline, Week 6, Months 3, 6, 9, 12Population: FAS. n = number of participants with evaluable data at that time point.
Hypertension was defined as follows. Grade 1: Asymptomatic, transient (less than \[\<\]24 hours) increase by \>20mm Hg (diastolic) or to \>150/100 mm Hg if previously within normal limits (WNL). Grade 2: Recurrent or persistent (24 hours or more) or symptomatic increase by \>20 mm Hg (diastolic) or to \>150/100 mm Hg if previously WNL. Grade 3: Requiring \>1 drug or more intensive therapy than previously. Grade 4: Life-threatening. Grade 5: Death.
Outcome measures
| Measure |
Sunitinib
n=186 Participants
The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
|
|---|---|
|
Percentage of Participants With Hypertension
Baseline (n=186)
|
64.0 percentage of participants
|
|
Percentage of Participants With Hypertension
Week 6 (n=182)
|
51.1 percentage of participants
|
|
Percentage of Participants With Hypertension
Month 3 (n=168)
|
48.8 percentage of participants
|
|
Percentage of Participants With Hypertension
Month 6 (n=131)
|
54.2 percentage of participants
|
|
Percentage of Participants With Hypertension
Month 9 (n=100)
|
54.0 percentage of participants
|
|
Percentage of Participants With Hypertension
Month 12 (n=134)
|
39.6 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to 12 monthsPopulation: Number of participants analyzed = All participants who required dose modification because of an adverse event. The total number of participants may exceed the number of participants analyzed because one participant may have reported more than one adverse event.
Adverse events (AEs) or treatment-emergent adverse events (TEAEs) were defined as newly occurring or worsening after first dose. Study drug modifications included reduced dose or temporary discontinuation of treatment.
Outcome measures
| Measure |
Sunitinib
n=17 Participants
The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
|
|---|---|
|
Summary of Adverse Events for Participants Who Required Dose Modification
Pyrexia
|
1 participants
|
|
Summary of Adverse Events for Participants Who Required Dose Modification
Anaemia
|
2 participants
|
|
Summary of Adverse Events for Participants Who Required Dose Modification
Leukopenia
|
2 participants
|
|
Summary of Adverse Events for Participants Who Required Dose Modification
Neutropenia
|
1 participants
|
|
Summary of Adverse Events for Participants Who Required Dose Modification
Thrombocytopenia
|
6 participants
|
|
Summary of Adverse Events for Participants Who Required Dose Modification
Hypothyroidism
|
1 participants
|
|
Summary of Adverse Events for Participants Who Required Dose Modification
Aphthous stomatitis
|
1 participants
|
|
Summary of Adverse Events for Participants Who Required Dose Modification
Stomatitis
|
2 participants
|
|
Summary of Adverse Events for Participants Who Required Dose Modification
Disease progression
|
9 participants
|
|
Summary of Adverse Events for Participants Who Required Dose Modification
Oedema peripheral
|
1 participants
|
|
Summary of Adverse Events for Participants Who Required Dose Modification
Jaundice
|
1 participants
|
|
Summary of Adverse Events for Participants Who Required Dose Modification
Bronchopneumonia
|
2 participants
|
|
Summary of Adverse Events for Participants Who Required Dose Modification
Herpes dermatitis
|
1 participants
|
|
Summary of Adverse Events for Participants Who Required Dose Modification
Urinary tract infection
|
2 participants
|
|
Summary of Adverse Events for Participants Who Required Dose Modification
False positive investigation result
|
1 participants
|
|
Summary of Adverse Events for Participants Who Required Dose Modification
Decreased appetite
|
2 participants
|
|
Summary of Adverse Events for Participants Who Required Dose Modification
Osteonecrosis of jaw
|
1 participants
|
|
Summary of Adverse Events for Participants Who Required Dose Modification
Leukaemia
|
1 participants
|
|
Summary of Adverse Events for Participants Who Required Dose Modification
Renal cell carcinoma
|
2 participants
|
|
Summary of Adverse Events for Participants Who Required Dose Modification
Cerebellar syndrome
|
1 participants
|
|
Summary of Adverse Events for Participants Who Required Dose Modification
Cerebrovascular accident
|
1 participants
|
|
Summary of Adverse Events for Participants Who Required Dose Modification
Loss of consciousness
|
1 participants
|
|
Summary of Adverse Events for Participants Who Required Dose Modification
Haematuria
|
1 participants
|
|
Summary of Adverse Events for Participants Who Required Dose Modification
Renal disorder
|
1 participants
|
|
Summary of Adverse Events for Participants Who Required Dose Modification
Asthma
|
1 participants
|
|
Summary of Adverse Events for Participants Who Required Dose Modification
Haemoptysis
|
1 participants
|
|
Summary of Adverse Events for Participants Who Required Dose Modification
Pulmonary embolism
|
1 participants
|
|
Summary of Adverse Events for Participants Who Required Dose Modification
Dermatitis exfoliative
|
1 participants
|
|
Summary of Adverse Events for Participants Who Required Dose Modification
Palmar-plantar erythrodysaesthesia syndrome
|
3 participants
|
|
Summary of Adverse Events for Participants Who Required Dose Modification
Rash
|
1 participants
|
|
Summary of Adverse Events for Participants Who Required Dose Modification
Skin erosion
|
1 participants
|
|
Summary of Adverse Events for Participants Who Required Dose Modification
Swelling face
|
1 participants
|
|
Summary of Adverse Events for Participants Who Required Dose Modification
Deep vein thrombosis
|
1 participants
|
|
Summary of Adverse Events for Participants Who Required Dose Modification
Hypertension
|
4 participants
|
|
Summary of Adverse Events for Participants Who Required Dose Modification
Infarction
|
1 participants
|
|
Summary of Adverse Events for Participants Who Required Dose Modification
Venous thrombosis limb
|
1 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to 12 monthsPopulation: All participants
Sunitinib-induced hypertension: not present at baseline but developed through the study, or if present at baseline increased by more than (\>) 20% during the study. Grade 1: Asymptomatic, transient (less than \[\<\]24 hours) increase by \>20 millimeters of Mercury (mm Hg) (diastolic) or to \>150/100 mm Hg if previously within normal limits (WNL); Grade 2: Recurrent or persistent (\>=24 hours) or symptomatic increase by \>20 mm Hg (diastolic) or to \>150/100 mm Hg if previously WNL; Grade 3: Requiring \>1 drug or more intensive therapy than previously; Grade 4: Life-threatening; Grade 5: Death.
Outcome measures
| Measure |
Sunitinib
n=186 Participants
The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
|
|---|---|
|
Percentage of Participants With Treatment-emergent Hypertension, by Common Terminology Criteria for Adverse Events (CTCAE) Grade
Hypertension, Grade 1
|
3.2 percentage of participants
|
|
Percentage of Participants With Treatment-emergent Hypertension, by Common Terminology Criteria for Adverse Events (CTCAE) Grade
Hypertension, Grade 2
|
1.1 percentage of participants
|
|
Percentage of Participants With Treatment-emergent Hypertension, by Common Terminology Criteria for Adverse Events (CTCAE) Grade
Hypertension, Grade 3
|
0.5 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsPopulation: All participants
Response categories for target lesions: Complete response (CR): Disappearance of all target lesions; Partial response (PR): At least a 30% decrease in the sum of the longest dimensions, reference=baseline sum of longest dimensions; Progressive disease (PD): At least a 20% increase in the sum of the longest dimensions, or the appearance of 1 or more new lesions; Stable disease (SD): Not sufficient shrinkage to qualify for PR, not sufficient increase to qualify for PD; Reference for PD and SD: smallest sum of longest dimensions since treatment started.
Outcome measures
| Measure |
Sunitinib
n=186 Participants
The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
|
|---|---|
|
Percentage of Participants Responding to Treatment
Complete response
|
2.2 percentage of participants
|
|
Percentage of Participants Responding to Treatment
Partial response
|
23.1 percentage of participants
|
|
Percentage of Participants Responding to Treatment
Stable / No response
|
46.2 percentage of participants
|
|
Percentage of Participants Responding to Treatment
Progressive disease
|
19.9 percentage of participants
|
Adverse Events
Sunitinib
Serious events: 31 serious events
Other events: 52 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sunitinib
n=186 participants at risk
The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.54%
1/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.2%
4/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Cardiac failure
|
0.54%
1/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Endocrine disorders
Hypothyroidism
|
0.54%
1/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.54%
1/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.54%
1/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Stomatitis
|
0.54%
1/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Disease progression
|
8.1%
15/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Bronchopneumonia
|
0.54%
1/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Empyema
|
0.54%
1/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.54%
1/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Weight decreased
|
0.54%
1/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.54%
1/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.54%
1/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.54%
1/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
0.54%
1/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.54%
1/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
1.1%
2/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Cerebellar syndrome
|
0.54%
1/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.54%
1/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Loss of consciousness
|
0.54%
1/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Haematuria
|
0.54%
1/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Renal disorder
|
0.54%
1/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.54%
1/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative
|
0.54%
1/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Deep vein thrombosis
|
0.54%
1/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Hypertension
|
0.54%
1/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Infarction
|
0.54%
1/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
Sunitinib
n=186 participants at risk
The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.54%
1/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.6%
3/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.6%
3/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.1%
2/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
4.3%
8/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Endocrine disorders
Hyperthyroidism
|
0.54%
1/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Endocrine disorders
Hypothyroidism
|
1.1%
2/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.54%
1/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.6%
3/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.54%
1/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
1.1%
2/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Periodontitis
|
0.54%
1/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Stomatitis
|
1.6%
3/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Adverse event
|
0.54%
1/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Chest pain
|
0.54%
1/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Disease progression
|
0.54%
1/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Face oedema
|
0.54%
1/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Fatigue
|
2.2%
4/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Mucosal inflammation
|
1.1%
2/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Oedema peripheral
|
1.1%
2/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Pyrexia
|
1.1%
2/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Hepatobiliary disorders
Jaundice
|
0.54%
1/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Bronchopneumonia
|
0.54%
1/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Herpes dermatitis
|
0.54%
1/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Urinary tract infection
|
1.1%
2/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Alanine aminotransferase increased
|
0.54%
1/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Aspartate aminotransferase increased
|
0.54%
1/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood creatinine increased
|
0.54%
1/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood parathyroid hormone increased
|
0.54%
1/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.54%
1/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
False positive investigation result
|
0.54%
1/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Weight decreased
|
1.1%
2/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.54%
1/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.2%
4/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.54%
1/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.54%
1/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.54%
1/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.54%
1/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.54%
1/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia
|
1.1%
2/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Paraesthesia
|
0.54%
1/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Insomnia
|
0.54%
1/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Urinary retention
|
0.54%
1/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.54%
1/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.54%
1/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.6%
3/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.54%
1/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.54%
1/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.54%
1/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
2.2%
4/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.2%
4/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.54%
1/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Skin erosion
|
0.54%
1/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Skin toxicity
|
0.54%
1/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Hypertension
|
4.3%
8/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Phlebitis
|
0.54%
1/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Varicose vein
|
0.54%
1/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Venous thrombosis limb
|
0.54%
1/186
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER