Trial Outcomes & Findings for Safety And Efficacy Study Of Sunitinib Malate As First-Line Systemic Therapy In Chinese Patients With Metastatic Renal Cell Carcinoma (NCT NCT00706706)
NCT ID: NCT00706706
Last Updated: 2013-01-18
Results Overview
Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease \[PD\]), or from adverse event (AE) data (where the outcome was "Death").
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
105 participants
Primary outcome timeframe
Baseline, Day 28 of Cycles 1, 2, 3, 4 and even cycles thereafter until disease progression or every 2 months until death (up to 88 weeks)
Results posted on
2013-01-18
Participant Flow
Participant milestones
| Measure |
Sunitinib
Sunitinib 50 milligram (mg) capsule orally once daily for 4 weeks followed by 2 weeks off-treatment period in cycles of 6 weeks until disease progression, unacceptable sunitinib-associated toxicity or withdrawal.
|
|---|---|
|
Overall Study
STARTED
|
105
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
105
|
Reasons for withdrawal
| Measure |
Sunitinib
Sunitinib 50 milligram (mg) capsule orally once daily for 4 weeks followed by 2 weeks off-treatment period in cycles of 6 weeks until disease progression, unacceptable sunitinib-associated toxicity or withdrawal.
|
|---|---|
|
Overall Study
Death
|
53
|
|
Overall Study
Lost to Follow-up
|
7
|
|
Overall Study
Study endpoint had reached
|
45
|
Baseline Characteristics
Safety And Efficacy Study Of Sunitinib Malate As First-Line Systemic Therapy In Chinese Patients With Metastatic Renal Cell Carcinoma
Baseline characteristics by cohort
| Measure |
Sunitinib
n=105 Participants
Sunitinib 50 mg capsule orally once daily for 4 weeks followed by 2 weeks off-treatment period in cycles of 6 weeks until disease progression, unacceptable sunitinib-associated toxicity or withdrawal.
|
|---|---|
|
Age Continuous
|
54.6 Years
STANDARD_DEVIATION 12.9 • n=39 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
79 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 28 of Cycles 1, 2, 3, 4 and even cycles thereafter until disease progression or every 2 months until death (up to 88 weeks)Population: Safety population included those participants who had taken at least one dose of the study drug.
Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease \[PD\]), or from adverse event (AE) data (where the outcome was "Death").
Outcome measures
| Measure |
Sunitinib
n=105 Participants
Sunitinib 50 mg capsule orally once daily for 4 weeks followed by 2 weeks off-treatment period in cycles of 6 weeks until disease progression, unacceptable sunitinib-associated toxicity or withdrawal.
|
|---|---|
|
Progression-free Survival (PFS)
|
61.7 Weeks
Interval 45.1 to 106.3
|
SECONDARY outcome
Timeframe: Baseline, Day 28 of Cycles 1, 2, 3, 4 and even cycles thereafter until disease progression or every 2 months until death (up to 88 weeks)Population: Per protocol (PP) population included those participants who had the disease under study, measurable disease and an adequate baseline disease assessment and had taken at least one dose of the study drug.
Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.
Outcome measures
| Measure |
Sunitinib
n=103 Participants
Sunitinib 50 mg capsule orally once daily for 4 weeks followed by 2 weeks off-treatment period in cycles of 6 weeks until disease progression, unacceptable sunitinib-associated toxicity or withdrawal.
|
|---|---|
|
Percentage of Participants With Objective Response (OR)
|
31.1 Percentage of participants
Interval 22.3 to 40.9
|
SECONDARY outcome
Timeframe: Baseline, Day 28 of Cycles 1, 2, 3, 4 and even cycles thereafter until disease progression or every 2 months until death (up to 88 weeks)Population: Safety population included those participants who had taken at least one dose of the study drug.
Time in weeks from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).
Outcome measures
| Measure |
Sunitinib
n=105 Participants
Sunitinib 50 mg capsule orally once daily for 4 weeks followed by 2 weeks off-treatment period in cycles of 6 weeks until disease progression, unacceptable sunitinib-associated toxicity or withdrawal.
|
|---|---|
|
Overall Survival (OS)
|
133.4 Weeks
Interval 94.1 to
Upper limit of confidence interval was not estimable due to the high number of participants censored for survival.
|
SECONDARY outcome
Timeframe: Baseline, Day 28 of Cycles 1, 2, 3, 4 and even cycles thereafter, every 2 months until death (up to 1 year)Population: Safety population included those participants who had taken at least one dose of the study drug.
One year survival probability was defined as the probability of survival at one year after the first dose of study treatment.
Outcome measures
| Measure |
Sunitinib
n=105 Participants
Sunitinib 50 mg capsule orally once daily for 4 weeks followed by 2 weeks off-treatment period in cycles of 6 weeks until disease progression, unacceptable sunitinib-associated toxicity or withdrawal.
|
|---|---|
|
One Year Survival Probability
|
72.0 Percent chance of survival
Interval 62.3 to 79.7
|
Adverse Events
Sunitinib
Serious events: 13 serious events
Other events: 102 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sunitinib
n=105 participants at risk
Sunitinib 50 mg capsule orally once daily for 4 weeks followed by 2 weeks off-treatment period in cycles of 6 weeks until disease progression, unacceptable sunitinib-associated toxicity or withdrawal.
|
|---|---|
|
Cardiac disorders
Right ventricular dysfunction
|
0.95%
1/105 • AEs/SAEs: From signing of informed consent form up to 28 days after last dose
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 nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Death
|
0.95%
1/105 • AEs/SAEs: From signing of informed consent form up to 28 days after last dose
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 nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Disease progression
|
2.9%
3/105 • AEs/SAEs: From signing of informed consent form up to 28 days after last dose
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 nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pneumonia
|
1.9%
2/105 • AEs/SAEs: From signing of informed consent form up to 28 days after last dose
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 nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood creatinine increased
|
0.95%
1/105 • AEs/SAEs: From signing of informed consent form up to 28 days after last dose
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 nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Platelet count decreased
|
0.95%
1/105 • AEs/SAEs: From signing of informed consent form up to 28 days after last dose
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 nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.95%
1/105 • AEs/SAEs: From signing of informed consent form up to 28 days after last dose
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 nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Haematuria
|
0.95%
1/105 • AEs/SAEs: From signing of informed consent form up to 28 days after last dose
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 nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Renal failure
|
0.95%
1/105 • AEs/SAEs: From signing of informed consent form up to 28 days after last dose
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 nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.95%
1/105 • AEs/SAEs: From signing of informed consent form up to 28 days after last dose
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 nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.95%
1/105 • AEs/SAEs: From signing of informed consent form up to 28 days after last dose
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 nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
Sunitinib
n=105 participants at risk
Sunitinib 50 mg capsule orally once daily for 4 weeks followed by 2 weeks off-treatment period in cycles of 6 weeks until disease progression, unacceptable sunitinib-associated toxicity or withdrawal.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
8.6%
9/105 • AEs/SAEs: From signing of informed consent form up to 28 days after last dose
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 nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Leukopenia
|
27.6%
29/105 • AEs/SAEs: From signing of informed consent form up to 28 days after last dose
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 nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
8.6%
9/105 • AEs/SAEs: From signing of informed consent form up to 28 days after last dose
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 nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Neutropenia
|
7.6%
8/105 • AEs/SAEs: From signing of informed consent form up to 28 days after last dose
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 nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
22.9%
24/105 • AEs/SAEs: From signing of informed consent form up to 28 days after last dose
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 nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Endocrine disorders
Hypothyroidism
|
24.8%
26/105 • AEs/SAEs: From signing of informed consent form up to 28 days after last dose
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 nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Eyelid oedema
|
22.9%
24/105 • AEs/SAEs: From signing of informed consent form up to 28 days after last dose
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 nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal distension
|
12.4%
13/105 • AEs/SAEs: From signing of informed consent form up to 28 days after last dose
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 nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
9.5%
10/105 • AEs/SAEs: From signing of informed consent form up to 28 days after last dose
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 nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Constipation
|
7.6%
8/105 • AEs/SAEs: From signing of informed consent form up to 28 days after last dose
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 nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
48.6%
51/105 • AEs/SAEs: From signing of informed consent form up to 28 days after last dose
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 nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Dry mouth
|
8.6%
9/105 • AEs/SAEs: From signing of informed consent form up to 28 days after last dose
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 nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Dyspepsia
|
18.1%
19/105 • AEs/SAEs: From signing of informed consent form up to 28 days after last dose
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 nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.7%
6/105 • AEs/SAEs: From signing of informed consent form up to 28 days after last dose
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 nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Haemorrhoids
|
6.7%
7/105 • AEs/SAEs: From signing of informed consent form up to 28 days after last dose
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 nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Mouth ulceration
|
28.6%
30/105 • AEs/SAEs: From signing of informed consent form up to 28 days after last dose
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 nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
14.3%
15/105 • AEs/SAEs: From signing of informed consent form up to 28 days after last dose
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 nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Stomatitis
|
17.1%
18/105 • AEs/SAEs: From signing of informed consent form up to 28 days after last dose
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 nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Toothache
|
7.6%
8/105 • AEs/SAEs: From signing of informed consent form up to 28 days after last dose
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 nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Vomiting
|
9.5%
10/105 • AEs/SAEs: From signing of informed consent form up to 28 days after last dose
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 nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Chest pain
|
7.6%
8/105 • AEs/SAEs: From signing of informed consent form up to 28 days after last dose
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 nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Face oedema
|
22.9%
24/105 • AEs/SAEs: From signing of informed consent form up to 28 days after last dose
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 nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Fatigue
|
51.4%
54/105 • AEs/SAEs: From signing of informed consent form up to 28 days after last dose
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 nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Mucosal inflammation
|
5.7%
6/105 • AEs/SAEs: From signing of informed consent form up to 28 days after last dose
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 nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Oedema
|
7.6%
8/105 • AEs/SAEs: From signing of informed consent form up to 28 days after last dose
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 nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Oedema peripheral
|
12.4%
13/105 • AEs/SAEs: From signing of informed consent form up to 28 days after last dose
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 nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Pyrexia
|
8.6%
9/105 • AEs/SAEs: From signing of informed consent form up to 28 days after last dose
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 nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Alanine aminotransferase increased
|
16.2%
17/105 • AEs/SAEs: From signing of informed consent form up to 28 days after last dose
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 nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Aspartate aminotransferase increased
|
15.2%
16/105 • AEs/SAEs: From signing of informed consent form up to 28 days after last dose
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 nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood bilirubin increased
|
9.5%
10/105 • AEs/SAEs: From signing of informed consent form up to 28 days after last dose
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 nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood calcium decreased
|
8.6%
9/105 • AEs/SAEs: From signing of informed consent form up to 28 days after last dose
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 nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood creatinine increased
|
18.1%
19/105 • AEs/SAEs: From signing of informed consent form up to 28 days after last dose
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 nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood glucose increased
|
5.7%
6/105 • AEs/SAEs: From signing of informed consent form up to 28 days after last dose
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 nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood phosphorus decreased
|
5.7%
6/105 • AEs/SAEs: From signing of informed consent form up to 28 days after last dose
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 nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
24.8%
26/105 • AEs/SAEs: From signing of informed consent form up to 28 days after last dose
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 nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood urea increased
|
8.6%
9/105 • AEs/SAEs: From signing of informed consent form up to 28 days after last dose
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 nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood uric acid increased
|
7.6%
8/105 • AEs/SAEs: From signing of informed consent form up to 28 days after last dose
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 nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Haemoglobin decreased
|
37.1%
39/105 • AEs/SAEs: From signing of informed consent form up to 28 days after last dose
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 nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Lymphocyte count decreased
|
7.6%
8/105 • AEs/SAEs: From signing of informed consent form up to 28 days after last dose
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 nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Lymphocyte count increased
|
8.6%
9/105 • AEs/SAEs: From signing of informed consent form up to 28 days after last dose
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 nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Neutrophil count decreased
|
39.0%
41/105 • AEs/SAEs: From signing of informed consent form up to 28 days after last dose
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 nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Platelet count decreased
|
51.4%
54/105 • AEs/SAEs: From signing of informed consent form up to 28 days after last dose
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 nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Thyroxine increased
|
5.7%
6/105 • AEs/SAEs: From signing of informed consent form up to 28 days after last dose
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 nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Weight decreased
|
21.9%
23/105 • AEs/SAEs: From signing of informed consent form up to 28 days after last dose
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 nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
White blood cell count decreased
|
52.4%
55/105 • AEs/SAEs: From signing of informed consent form up to 28 days after last dose
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 nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
42.9%
45/105 • AEs/SAEs: From signing of informed consent form up to 28 days after last dose
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 nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.3%
14/105 • AEs/SAEs: From signing of informed consent form up to 28 days after last dose
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 nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.7%
7/105 • AEs/SAEs: From signing of informed consent form up to 28 days after last dose
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 nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Dizziness
|
12.4%
13/105 • AEs/SAEs: From signing of informed consent form up to 28 days after last dose
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 nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Dysgeusia
|
27.6%
29/105 • AEs/SAEs: From signing of informed consent form up to 28 days after last dose
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 nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Headache
|
5.7%
6/105 • AEs/SAEs: From signing of informed consent form up to 28 days after last dose
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 nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Insomnia
|
5.7%
6/105 • AEs/SAEs: From signing of informed consent form up to 28 days after last dose
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 nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Proteinuria
|
7.6%
8/105 • AEs/SAEs: From signing of informed consent form up to 28 days after last dose
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 nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Reproductive system and breast disorders
Genital rash
|
5.7%
6/105 • AEs/SAEs: From signing of informed consent form up to 28 days after last dose
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 nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.6%
8/105 • AEs/SAEs: From signing of informed consent form up to 28 days after last dose
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 nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
10.5%
11/105 • AEs/SAEs: From signing of informed consent form up to 28 days after last dose
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 nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.7%
7/105 • AEs/SAEs: From signing of informed consent form up to 28 days after last dose
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 nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
6.7%
7/105 • AEs/SAEs: From signing of informed consent form up to 28 days after last dose
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 nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Hair colour changes
|
10.5%
11/105 • AEs/SAEs: From signing of informed consent form up to 28 days after last dose
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 nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
63.8%
67/105 • AEs/SAEs: From signing of informed consent form up to 28 days after last dose
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 nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
26.7%
28/105 • AEs/SAEs: From signing of informed consent form up to 28 days after last dose
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 nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
13.3%
14/105 • AEs/SAEs: From signing of informed consent form up to 28 days after last dose
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 nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
5.7%
6/105 • AEs/SAEs: From signing of informed consent form up to 28 days after last dose
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 nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Yellow skin
|
14.3%
15/105 • AEs/SAEs: From signing of informed consent form up to 28 days after last dose
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 nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Hypertension
|
37.1%
39/105 • AEs/SAEs: From signing of informed consent form up to 28 days after last dose
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 nonserious in another subject, or one subject 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