Trial Outcomes & Findings for Sutent Rechallenge In mRCC Patients (NCT NCT01827254)
NCT ID: NCT01827254
Last Updated: 2015-04-30
Results Overview
The PFS was defined as the time interval between the start date of treatment and the date of progression as assessed by the investigator or date of death occurring after treatment initiation, whichever occurred first. Duration of progression free survival= \[(Date of mRCC progression - Start date of the treatment) + 1)\]/ 365.25 x 12. Progression was defined as an increase in visible disease.
Recruitment status
COMPLETED
Target enrollment
61 participants
Primary outcome timeframe
From start of treatment up to 66.6 months
Results posted on
2015-04-30
Participant Flow
Participant milestones
| Measure |
Metastatic Renal Cell Carcinoma (mRCC) Cohort
Participants diagnosed with mRCC who met the selection criteria and received first-line sunitinib as per standard local practice, followed by one or more lines of different treatments (bevacizumab with interferon, bevacizumab without interferon, sorafenib, axitinib, temsirolimus or everolimus), and, lastly were rechallenged with sunitinib between 2006 and May 2013 were included in this non-interventional study.
|
|---|---|
|
Overall Study
STARTED
|
61
|
|
Overall Study
Evaluable Population
|
52
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
59
|
Reasons for withdrawal
| Measure |
Metastatic Renal Cell Carcinoma (mRCC) Cohort
Participants diagnosed with mRCC who met the selection criteria and received first-line sunitinib as per standard local practice, followed by one or more lines of different treatments (bevacizumab with interferon, bevacizumab without interferon, sorafenib, axitinib, temsirolimus or everolimus), and, lastly were rechallenged with sunitinib between 2006 and May 2013 were included in this non-interventional study.
|
|---|---|
|
Overall Study
Death
|
10
|
|
Overall Study
Case report form not completed
|
4
|
|
Overall Study
Invalidated centre
|
3
|
|
Overall Study
Discontinued prior initiation: sunitinib
|
1
|
|
Overall Study
Did not complete re-challenge
|
1
|
|
Overall Study
Disease progression
|
36
|
|
Overall Study
Intolerance to treatment
|
4
|
Baseline Characteristics
Sutent Rechallenge In mRCC Patients
Baseline characteristics by cohort
| Measure |
Metastatic Renal Cell Carcinoma (mRCC) Cohort
n=52 Participants
Participants diagnosed with mRCC who met the selection criteria and received first-line sunitinib as per standard local practice, followed by one or more lines of different treatments (bevacizumab with interferon, bevacizumab without interferon, sorafenib, axitinib, temsirolimus or everolimus), and, lastly were rechallenged with sunitinib between 2006 and May 2013 were included in this non-interventional study.
|
|---|---|
|
Age, Continuous
|
60.1 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From start of treatment up to 66.6 monthsPopulation: Evaluable population: All participants included in the analysis.
The PFS was defined as the time interval between the start date of treatment and the date of progression as assessed by the investigator or date of death occurring after treatment initiation, whichever occurred first. Duration of progression free survival= \[(Date of mRCC progression - Start date of the treatment) + 1)\]/ 365.25 x 12. Progression was defined as an increase in visible disease.
Outcome measures
| Measure |
Metastatic Renal Cell Carcinoma (mRCC) Cohort
n=52 Participants
Participants diagnosed with metastatic renal cell carcinoma (MRCC) who met the selection criteria and received sunitinib as first-line therapy as per standard local practice.
|
|---|---|
|
Progression Free Survival With Sunitinib as First Line of Therapy
|
18.4 months
Interval 12.5 to 23.7
|
PRIMARY outcome
Timeframe: From start of treatment up to 52.2 monthsPopulation: Evaluable population: All participants included in the analysis. Here "N" signifies number of participants who were analyzed for this outcome measure.
The PFS was defined as the time interval between the start date of treatment and the date of progression as assessed by the investigator or date of death occurring after treatment initiation, whichever occurred first. Duration of progression free survival= \[(Date of mRCC progression - Start date of the treatment) + 1)\]/ 365.25 x 12. Progression was defined as an increase in visible disease.
Outcome measures
| Measure |
Metastatic Renal Cell Carcinoma (mRCC) Cohort
n=51 Participants
Participants diagnosed with metastatic renal cell carcinoma (MRCC) who met the selection criteria and received sunitinib as first-line therapy as per standard local practice.
|
|---|---|
|
Progression Free Survival for Re-challenge With Sunitinib
|
7.9 months
Interval 5.4 to 13.2
|
PRIMARY outcome
Timeframe: From start of treatment up to 22.9 monthsPopulation: Evaluable population: All participants included in the analysis. Here "N" signifies number of participants who were analyzed for this outcome measure and "n" signifies those participants who were evaluable for respective treatment group.
The PFS was defined as the time interval between the start date of treatment and the date of progression as assessed by the investigator or date of death occurring after treatment initiation, whichever occurred first. Duration of progression free survival= \[(Date of mRCC progression - Start date of the treatment) + 1)\]/ 365.25 x 12. Progression was defined as an increase in visible disease. Second-line treatment were divided in two groups: Group A (received treatment with: bevacizumab (with interferon), bevacizumab (without interferon), sorafenib, axitinib) and Group B (received treatment with: temsirolimus, everolimus).
Outcome measures
| Measure |
Metastatic Renal Cell Carcinoma (mRCC) Cohort
n=50 Participants
Participants diagnosed with metastatic renal cell carcinoma (MRCC) who met the selection criteria and received sunitinib as first-line therapy as per standard local practice.
|
|---|---|
|
Progression Free Survival: Second Line of Treatment
Group A (n=21)
|
5.0 months
Interval 2.8 to 7.0
|
|
Progression Free Survival: Second Line of Treatment
Group B (n=29)
|
6.2 months
Interval 3.7 to 7.9
|
PRIMARY outcome
Timeframe: From start of treatment up to 23.7 monthsPopulation: Evaluable population: All participants included in the analysis. Here "N" signifies number of participants who were analyzed for this outcome measure and "n" signifies those participants who were evaluable for respective treatment group.
The PFS was defined as the time interval between the start date of treatment and the date of progression as assessed by the investigator or date of death occurring after treatment initiation, whichever occurred first. Duration of progression free survival= \[(Date of mRCC progression - Start date of the treatment) + 1)\]/ 365.25 x 12. Progression was defined as an increase in visible disease. Third-line treatment were divided in two groups: Group A (received treatment with: bevacizumab (with interferon), bevacizumab (without interferon), sorafenib, axitinib) and Group B (received treatment with: temsirolimus, everolimus).
Outcome measures
| Measure |
Metastatic Renal Cell Carcinoma (mRCC) Cohort
n=39 Participants
Participants diagnosed with metastatic renal cell carcinoma (MRCC) who met the selection criteria and received sunitinib as first-line therapy as per standard local practice.
|
|---|---|
|
Progression Free Survival: Third Line Treatment
Group A (n=20)
|
4.8 months
Interval 3.1 to 8.7
|
|
Progression Free Survival: Third Line Treatment
Group B (n=19)
|
10.8 months
Interval 7.0 to 14.6
|
SECONDARY outcome
Timeframe: Baseline up to death or end of study (up to 98.0 months)Population: Evaluable population: All participants included in the analysis.
Overall survival of patients under treatment was evaluated by calculating the time between date of initiation of treatment (1st line) and date of death, if the latter occurred before the end of the study. Duration of Overall Survival =(Date of death - Start date of treatment) + 1)/365.25 x 12.
Outcome measures
| Measure |
Metastatic Renal Cell Carcinoma (mRCC) Cohort
n=52 Participants
Participants diagnosed with metastatic renal cell carcinoma (MRCC) who met the selection criteria and received sunitinib as first-line therapy as per standard local practice.
|
|---|---|
|
Overall Survival
|
55.9 months
Interval 48.0 to 63.7
|
SECONDARY outcome
Timeframe: Baseline up to 98.0 monthsPopulation: Evaluable population: All participants included in the analysis.
Percentage of participants with objective response based assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as complete disappearance of all target lesions and non-target lesions, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis \<10 mm). No new lesions. PR was defined as \>=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. Percentage of participants with objective response was calculated for the 1st-line of therapy with Sunitinib, Sunitinib re-challenge and for retreatment with Sunitinib as 3rd-line of therapy or more.
Outcome measures
| Measure |
Metastatic Renal Cell Carcinoma (mRCC) Cohort
n=52 Participants
Participants diagnosed with metastatic renal cell carcinoma (MRCC) who met the selection criteria and received sunitinib as first-line therapy as per standard local practice.
|
|---|---|
|
Percentage of Participants With Objective Response
First line treatment
|
53.8 percentage of participants
Interval 40.3 to 67.4
|
|
Percentage of Participants With Objective Response
Third line treatment
|
15.4 percentage of participants
Interval 5.6 to 25.2
|
|
Percentage of Participants With Objective Response
Sunitinib re-challenge
|
75.0 percentage of participants
Interval 45.0 to 100.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to 24 monthsPopulation: Evaluable population: All participants included in the analysis.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs include both serious as well as non-serious AEs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Outcome measures
| Measure |
Metastatic Renal Cell Carcinoma (mRCC) Cohort
n=52 Participants
Participants diagnosed with metastatic renal cell carcinoma (MRCC) who met the selection criteria and received sunitinib as first-line therapy as per standard local practice.
|
|---|---|
|
Number of Participant With Adverse Events (AEs) or Serious Adverse Events (SAEs)
AEs
|
24 participants
Interval 48.0 to 63.7
|
|
Number of Participant With Adverse Events (AEs) or Serious Adverse Events (SAEs)
SAEs
|
21 participants
|
Adverse Events
Metastatic Renal Cell Carcinoma (mRCC) Cohort
Serious events: 21 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Metastatic Renal Cell Carcinoma (mRCC) Cohort
n=52 participants at risk
Participants diagnosed with mRCC who met the selection criteria and received first-line sunitinib as per standard local practice, followed by one or more lines of different treatments (bevacizumab with interferon, bevacizumab without interferon, sorafenib, axitinib, temsirolimus or everolimus), and, lastly were rechallenged with sunitinib between 2006 and May 2013 were included in this non-interventional study.
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
3.8%
2/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Death
|
7.7%
4/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Disease progression
|
17.3%
9/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
General disorders
General physical health deterioration
|
3.8%
2/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Clavicle fracture
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic renal cell carcinoma
|
3.8%
2/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
7.7%
4/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer metastatic
|
5.8%
3/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Confusional state
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Skin toxicity
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
Other adverse events
| Measure |
Metastatic Renal Cell Carcinoma (mRCC) Cohort
n=52 participants at risk
Participants diagnosed with mRCC who met the selection criteria and received first-line sunitinib as per standard local practice, followed by one or more lines of different treatments (bevacizumab with interferon, bevacizumab without interferon, sorafenib, axitinib, temsirolimus or everolimus), and, lastly were rechallenged with sunitinib between 2006 and May 2013 were included in this non-interventional study.
|
|---|---|
|
Renal and urinary disorders
Proteinuria
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Renal disorder
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.8%
2/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
Anaemia
|
3.8%
2/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
Macrocytosis
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Ear and labyrinth disorders
Vertigo
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Endocrine disorders
Hypothyroidism
|
3.8%
2/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Eye disorders
Conjunctivitis
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Eye disorders
Visual impairment
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.8%
2/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Constipation
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
9.6%
5/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.8%
3/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Flatulence
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Gastrointestinal toxicity
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Gingivitis
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
3.8%
2/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Stomatitis
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Vomiting
|
5.8%
3/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Asthenia
|
15.4%
8/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Fatigue
|
5.8%
3/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
General disorders
General physical health deterioration
|
3.8%
2/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Mucosal inflammation
|
3.8%
2/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Oedema
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Oedema peripheral
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
3.8%
2/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Weight decreased
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Ageusia
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Dizziness
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Dysgeusia
|
3.8%
2/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Sciatica
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Haematuria
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Hair colour changes
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
5.8%
3/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Blood pressure inadequately controlled
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Hypertension
|
3.8%
2/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious 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