Trial Outcomes & Findings for SU011248 In The Treatment Of Patients With Bevacizumab (Avastin)-Refractory Metastatic Renal Cell Carcinoma (NCT NCT00089648)
NCT ID: NCT00089648
Last Updated: 2010-01-12
Results Overview
Objective disease response = subjects with confirmed complete response (CR) or partial response (PR) according to RECIST. A CR was defined as the disappearance of all target lesions. A PR was defined as a ≥ 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
COMPLETED
PHASE2
61 participants
4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation including 28 day post study follow up
2010-01-12
Participant Flow
Participant milestones
| Measure |
Sunitinib
50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
|
|---|---|
|
Overall Study
STARTED
|
61
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
41
|
Reasons for withdrawal
| Measure |
Sunitinib
50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
|
|---|---|
|
Overall Study
Adverse Event
|
7
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Lack of Efficacy
|
33
|
Baseline Characteristics
SU011248 In The Treatment Of Patients With Bevacizumab (Avastin)-Refractory Metastatic Renal Cell Carcinoma
Baseline characteristics by cohort
| Measure |
Sunitinib
n=61 Participants
50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
|
|---|---|
|
Age, Customized
< 65 years
|
43 participants
n=5 Participants
|
|
Age, Customized
> = 65 years
|
18 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation including 28 day post study follow upPopulation: Intent-to-treat (ITT)=all subjects enrolled in the study that received at least 1 dose of study medication.
Objective disease response = subjects with confirmed complete response (CR) or partial response (PR) according to RECIST. A CR was defined as the disappearance of all target lesions. A PR was defined as a ≥ 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=61 Participants
50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
|
|---|---|
|
Number of Subjects With Overall Confirmed Objective Disease Response According to the Response Evaluation Criteria in Solid Tumors (RECIST)
|
14 participants
|
SECONDARY outcome
Timeframe: 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation including 28 day post study follow upPopulation: ITT. 20 subjects were censored.
TTP was defined as the time from the date of first dose of study medication to the date of the first documentation of tumor progression. If tumor progression data included more than 1 date, the first date was used. TTP (in weeks) was calculated as (first event date minus first dose date +1)/7. Kaplan-Meier method was used.
Outcome measures
| Measure |
Sunitinib
n=61 Participants
50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
|
|---|---|
|
Time to Tumor Progression (TTP)
|
30.4 weeks
Interval 18.3 to 36.7
|
SECONDARY outcome
Timeframe: 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation including 28 day post study follow upPopulation: ITT subjects (i.e, all subjects enrolled in the study that received at least 1 dose of study medication) who had a confirmed CR or PR. 14 subjects who had a response were analyzed for DR.
DR was defined as the time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression or to death due to to any cause that occurred within 28 days after the last dose of study medication, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. DR was only calculated for the subgroup of subjects with a confirmed objective response. DR was calculated as \[the end date for DR minus first CR or PR that was subsequently confirmed +1\]/7. Kaplan-Meier method was used.
Outcome measures
| Measure |
Sunitinib
n=61 Participants
50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
|
|---|---|
|
Duration of Response (DR)
|
36.1 weeks
Interval 25.0 to 999.0
|
SECONDARY outcome
Timeframe: 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation including 28 day post study follow upPopulation: ITT
OS was defined as the time from start of study treatment to date of death due to any cause. OS (in weeks) was calculated as \[date of death minus first dose date +1\]/7. For a subject not expiring, the OS time was censored on the last date of known contact that they were known to be alive. Subjects lacking data beyond the day of the first dose had their OS times censored at 1 day. Kaplan-Meier method was used.
Outcome measures
| Measure |
Sunitinib
n=61 Participants
50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
|
|---|---|
|
Overall Survival (OS)
|
47.1 weeks
Interval 36.9 to 69.7
|
SECONDARY outcome
Timeframe: 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation including 28 day post study follow upPopulation: ITT. 20 subjects were censored.
PFS was defined as the time from start of study medication to first documentation of objective tumor progression or to death due to any cause that occurred on treatment including within 28 days after the last dose of study medication, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. PFS (in weeks) was calculated as (first event date minus first dose date +1)/7. Kaplan-Meier method was used.
Outcome measures
| Measure |
Sunitinib
n=61 Participants
50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
|
|---|---|
|
Progression Free Survival (PFS)
|
30.4 weeks
Interval 18.3 to 36.7
|
SECONDARY outcome
Timeframe: Day 28 of Cycle 1 to Cycle 4Population: ITT
Outcome measures
| Measure |
Sunitinib
n=59 Participants
50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
|
|---|---|
|
Trough Plasma Concentrations (Cmin) of Sunitinib
Cycle 1, Day 28 (n=20)
|
52.05 ng/mL
Interval 29.8 to 91.4
|
|
Trough Plasma Concentrations (Cmin) of Sunitinib
Cycle 2, Day 28 (n=23)
|
43.50 ng/mL
Interval 8.69 to 93.0
|
|
Trough Plasma Concentrations (Cmin) of Sunitinib
Cycle 3, Day 28 (n=10)
|
46.10 ng/mL
Interval 24.8 to 72.0
|
|
Trough Plasma Concentrations (Cmin) of Sunitinib
Cycle 4, Day 28 (n=16)
|
44.90 ng/mL
Interval 13.1 to 103.0
|
SECONDARY outcome
Timeframe: Day 28 of Cycle 1 to Cycle 4Population: ITT
Outcome measures
| Measure |
Sunitinib
n=59 Participants
50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
|
|---|---|
|
Trough Plasma Concentrations (Cmin) of SU012662
Cycle 1, Day 28 (n=20)
|
30.50 ng/mL
Interval 14.1 to 64.0
|
|
Trough Plasma Concentrations (Cmin) of SU012662
Cycle 2, Day 28 (n=23)
|
21.40 ng/mL
Interval 5.51 to 55.2
|
|
Trough Plasma Concentrations (Cmin) of SU012662
Cycle 3, Day 28 (n=10)
|
22.10 ng/mL
Interval 8.49 to 40.7
|
|
Trough Plasma Concentrations (Cmin) of SU012662
Cycle 4, Day 28 (n=16)
|
23.75 ng/mL
Interval 11.4 to 47.8
|
SECONDARY outcome
Timeframe: Day 28 of Cycle 1 to Cycle 4Population: ITT
Outcome measures
| Measure |
Sunitinib
n=59 Participants
50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
|
|---|---|
|
Trough Plasma Concentrations (Cmin) of Total Drug (Sunitinib + SU012662)
Cycle 1, Day 28 (n=20)
|
85.40 ng/mL
Interval 43.9 to 141.7
|
|
Trough Plasma Concentrations (Cmin) of Total Drug (Sunitinib + SU012662)
Cycle 2, Day 28 (n=23)
|
66.60 ng/mL
Interval 18.32 to 129.4
|
|
Trough Plasma Concentrations (Cmin) of Total Drug (Sunitinib + SU012662)
Cycle 3, Day 28 (n=10)
|
68.40 ng/mL
Interval 41.29 to 106.1
|
|
Trough Plasma Concentrations (Cmin) of Total Drug (Sunitinib + SU012662)
Cycle 4, Day 28 (n=16)
|
68.15 ng/mL
Interval 29.2 to 126.0
|
SECONDARY outcome
Timeframe: Cycle 1 (Days 1, 14, and 28), Cycle 2 (Day 1)Population: ITT
Plasma concentrations of VEGF-A that may be associated with tumor proliferation or angiogenesis collected from a subset of subjects were analyzed by ELISA analysis. Samples below the limit of quantitation and samples with insufficient volume available were excluded.
Outcome measures
| Measure |
Sunitinib
n=61 Participants
50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
|
|---|---|
|
Plasma Concentration of Vascular Endothelial Growth Factor-A (VEGF-A)
Cycle 1, Day 1 (Baseline) (n=59)
|
567.4 pg/mL
Interval 57.0 to 3692.0
|
|
Plasma Concentration of Vascular Endothelial Growth Factor-A (VEGF-A)
Cycle 1, Day 14 (n=57)
|
1320.6 pg/mL
Interval 104.5 to 4751.0
|
|
Plasma Concentration of Vascular Endothelial Growth Factor-A (VEGF-A)
Cycle 1, Day 28 (n=55)
|
1212.3 pg/mL
Interval 105.2 to 6137.0
|
|
Plasma Concentration of Vascular Endothelial Growth Factor-A (VEGF-A)
Cycle 2, Day 1 (n=54)
|
316.2 pg/mL
Interval 56.9 to 1724.0
|
SECONDARY outcome
Timeframe: Cycle 1 (Days 1, 14, and 28), Cycle 2 (Day 1)Population: ITT
Plasma concentrations of sVEGFR-3 that may be associated with tumor proliferation or angiogenesis collected from a subset of subjects were analyzed by ELISA analysis. Samples below the limit of quantitation and samples with insufficient volume available were excluded.
Outcome measures
| Measure |
Sunitinib
n=61 Participants
50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
|
|---|---|
|
Plasma Concentration of Soluble VEGF Receptor-3 (sVEGFR-3)
Cycle 1, Day 1 (Baseline) (n=54)
|
54170.4 pg/mL
Interval 21300.0 to 202900.0
|
|
Plasma Concentration of Soluble VEGF Receptor-3 (sVEGFR-3)
Cycle 1, Day 14 (n=32)
|
37747.0 pg/mL
Interval 21500.0 to 122900.0
|
|
Plasma Concentration of Soluble VEGF Receptor-3 (sVEGFR-3)
Cycle 1, Day 28 (n=22)
|
46891.0 pg/mL
Interval 22700.0 to 109700.0
|
|
Plasma Concentration of Soluble VEGF Receptor-3 (sVEGFR-3)
Cycle 2, Day 1 (n=46)
|
51280.0 pg/mL
Interval 21700.0 to 122900.0
|
SECONDARY outcome
Timeframe: Cycle 1 (Days 1, 14, and 28)Population: ITT
Plasma concentrations of PlGF that may be associated with tumor proliferation or angiogenesis collected from a subset of subjects were analyzed by ELISA analysis. Samples below the limit of quantitation and samples with insufficient volume available were excluded.
Outcome measures
| Measure |
Sunitinib
n=61 Participants
50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
|
|---|---|
|
Plasma Concentration of Placental Growth Factor (PlGF)
Cycle 1, Day 1 (Baseline) (n=37)
|
55.0 pg/mL
Interval 24.4 to 257.0
|
|
Plasma Concentration of Placental Growth Factor (PlGF)
Cycle 1, Day 14 (n=58)
|
146.1 pg/mL
Interval 44.8 to 408.0
|
|
Plasma Concentration of Placental Growth Factor (PlGF)
Cycle 1, Day 28 (n=53)
|
137.9 pg/mL
Interval 28.2 to 490.0
|
SECONDARY outcome
Timeframe: Cycle 1 (Days 1, 14, and 28)Population: ITT
Plasma concentrations of VEGF-C that may be associated with tumor proliferation or angiogenesis collected from a subset of subjects were analyzed by ELISA analysis. Samples below the limit of quantitation and samples with insufficient volume available were excluded.
Outcome measures
| Measure |
Sunitinib
n=61 Participants
50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
|
|---|---|
|
Plasma Concentration of VEGF-C
Cycle 1, Day 1 (Baseline) (n=57)
|
833.0 pg/mL
Interval 332.0 to 3167.0
|
|
Plasma Concentration of VEGF-C
Cycle 1, Day 14 (n=57)
|
688.0 pg/mL
Interval 284.5 to 1353.0
|
|
Plasma Concentration of VEGF-C
Cycle 1, Day 28 (n=54)
|
566.5 pg/mL
Interval 213.0 to 1391.0
|
SECONDARY outcome
Timeframe: 1 yearPlasma concentrations of sVEGFR-2 that may be associated with tumor proliferation or angiogenesis collected from a subset of subjects were to have been analyzed by ELISA analysis; however, no data were collected.
Outcome measures
Outcome data not reported
Adverse Events
Sunitinib
Serious adverse events
| Measure |
Sunitinib
n=61 participants at risk
50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.3%
2/61
|
|
Cardiac disorders
Angina pectoris
|
1.6%
1/61
|
|
Cardiac disorders
Atrial fibrillation
|
1.6%
1/61
|
|
Cardiac disorders
Pericardial effusion
|
1.6%
1/61
|
|
Endocrine disorders
Adrenal insufficiency
|
3.3%
2/61
|
|
Endocrine disorders
Hypothyroidism
|
1.6%
1/61
|
|
Gastrointestinal disorders
Nausea
|
6.6%
4/61
|
|
Gastrointestinal disorders
Vomiting
|
6.6%
4/61
|
|
Gastrointestinal disorders
Abdominal pain
|
3.3%
2/61
|
|
Gastrointestinal disorders
Ascites
|
3.3%
2/61
|
|
Gastrointestinal disorders
Diarrhoea
|
3.3%
2/61
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
3.3%
2/61
|
|
Gastrointestinal disorders
Abdominal distension
|
1.6%
1/61
|
|
Gastrointestinal disorders
Abdominal pain lower
|
1.6%
1/61
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
1.6%
1/61
|
|
General disorders
Disease progression
|
8.2%
5/61
|
|
General disorders
Fatigue
|
6.6%
4/61
|
|
General disorders
Pyrexia
|
3.3%
2/61
|
|
General disorders
Chest pain
|
1.6%
1/61
|
|
General disorders
Generalised oedema
|
1.6%
1/61
|
|
General disorders
Oedema
|
1.6%
1/61
|
|
General disorders
Pain
|
1.6%
1/61
|
|
Infections and infestations
Diverticulitis
|
3.3%
2/61
|
|
Infections and infestations
Pneumonia
|
3.3%
2/61
|
|
Infections and infestations
Wound infection
|
3.3%
2/61
|
|
Infections and infestations
Abdominal abscess
|
1.6%
1/61
|
|
Infections and infestations
Appendicitis
|
1.6%
1/61
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
1.6%
1/61
|
|
Investigations
Activated partial thromboplastin time prolonged
|
1.6%
1/61
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
1.6%
1/61
|
|
Metabolism and nutrition disorders
Dehydration
|
4.9%
3/61
|
|
Metabolism and nutrition disorders
Anorexia
|
3.3%
2/61
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.6%
1/61
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.6%
1/61
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.6%
1/61
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
1.6%
1/61
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
1.6%
1/61
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.6%
1/61
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
1.6%
1/61
|
|
Nervous system disorders
Cerebral haemorrhage
|
1.6%
1/61
|
|
Nervous system disorders
Depressed level of consciousness
|
1.6%
1/61
|
|
Nervous system disorders
Loss of consciousness
|
1.6%
1/61
|
|
Nervous system disorders
Spinal cord compression
|
1.6%
1/61
|
|
Nervous system disorders
Syncope
|
1.6%
1/61
|
|
Psychiatric disorders
Confusional state
|
1.6%
1/61
|
|
Psychiatric disorders
Psychotic disorder
|
1.6%
1/61
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.2%
5/61
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.3%
2/61
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.6%
1/61
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.6%
1/61
|
|
Skin and subcutaneous tissue disorders
Angioneurotic oedema
|
1.6%
1/61
|
|
Vascular disorders
Deep vein thrombosis
|
3.3%
2/61
|
Other adverse events
| Measure |
Sunitinib
n=61 participants at risk
50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
|
|---|---|
|
Nervous system disorders
Peripheral sensory neuropathy
|
6.6%
4/61
|
|
Psychiatric disorders
Anxiety
|
9.8%
6/61
|
|
Blood and lymphatic system disorders
Anaemia
|
26.2%
16/61
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.6%
4/61
|
|
Endocrine disorders
Hypothyroidism
|
23.0%
14/61
|
|
Eye disorders
Lacrimation increased
|
8.2%
5/61
|
|
Gastrointestinal disorders
Abdominal distension
|
6.6%
4/61
|
|
Gastrointestinal disorders
Abdominal pain
|
16.4%
10/61
|
|
Gastrointestinal disorders
Cheilitis
|
13.1%
8/61
|
|
Gastrointestinal disorders
Constipation
|
41.0%
25/61
|
|
Gastrointestinal disorders
Diarrhoea
|
68.9%
42/61
|
|
Gastrointestinal disorders
Dry mouth
|
9.8%
6/61
|
|
Gastrointestinal disorders
Dyspepsia
|
32.8%
20/61
|
|
Gastrointestinal disorders
Eructation
|
6.6%
4/61
|
|
Gastrointestinal disorders
Flatulence
|
11.5%
7/61
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
16.4%
10/61
|
|
Gastrointestinal disorders
Glossodynia
|
6.6%
4/61
|
|
Gastrointestinal disorders
Haemorrhoids
|
11.5%
7/61
|
|
Gastrointestinal disorders
Nausea
|
60.7%
37/61
|
|
Gastrointestinal disorders
Stomatitis
|
45.9%
28/61
|
|
Gastrointestinal disorders
Vomiting
|
47.5%
29/61
|
|
General disorders
Chest pain
|
13.1%
8/61
|
|
General disorders
Chills
|
19.7%
12/61
|
|
General disorders
Fatigue
|
88.5%
54/61
|
|
General disorders
Mucosal inflammation
|
34.4%
21/61
|
|
General disorders
Oedema peripheral
|
32.8%
20/61
|
|
General disorders
Pain
|
8.2%
5/61
|
|
General disorders
Pyrexia
|
21.3%
13/61
|
|
Infections and infestations
Sinusitis
|
13.1%
8/61
|
|
Infections and infestations
Upper respiratory tract infection
|
8.2%
5/61
|
|
Infections and infestations
Urinary tract infection
|
16.4%
10/61
|
|
Infections and infestations
Excoriation
|
6.6%
4/61
|
|
Investigations
Alanine aminotransferase increased
|
9.8%
6/61
|
|
Investigations
Aspartate aminotransferase increased
|
13.1%
8/61
|
|
Investigations
Blood creatinine increased
|
14.8%
9/61
|
|
Investigations
Blood glucose increased
|
6.6%
4/61
|
|
Investigations
Blood phosphorus decreased
|
6.6%
4/61
|
|
Investigations
Blood uric acid increased
|
6.6%
4/61
|
|
Investigations
Ejection fraction decreased
|
11.5%
7/61
|
|
Investigations
Haemoglobin decreased
|
8.2%
5/61
|
|
Investigations
Lipase increased
|
8.2%
5/61
|
|
Investigations
Neutrophil count decreased
|
13.1%
8/61
|
|
Investigations
Platelet count decreased
|
8.2%
5/61
|
|
Investigations
Weight decreased
|
18.0%
11/61
|
|
Investigations
Weight increased
|
8.2%
5/61
|
|
Investigations
White blood cell count decreased
|
11.5%
7/61
|
|
Metabolism and nutrition disorders
Anorexia
|
60.7%
37/61
|
|
Metabolism and nutrition disorders
Dehydration
|
14.8%
9/61
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
9.8%
6/61
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
6.6%
4/61
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
8.2%
5/61
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
9.8%
6/61
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
6.6%
4/61
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.1%
8/61
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
23.0%
14/61
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
6.6%
4/61
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.6%
4/61
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
6.6%
4/61
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
6.6%
4/61
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
8.2%
5/61
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
13.1%
8/61
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
8.2%
5/61
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
32.8%
20/61
|
|
Nervous system disorders
Dizziness
|
19.7%
12/61
|
|
Nervous system disorders
Dysgeusia
|
55.7%
34/61
|
|
Nervous system disorders
Headache
|
23.0%
14/61
|
|
Psychiatric disorders
Confusional state
|
6.6%
4/61
|
|
Psychiatric disorders
Insomnia
|
21.3%
13/61
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
32.8%
20/61
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
8.2%
5/61
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
36.1%
22/61
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
16.4%
10/61
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
6.6%
4/61
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.6%
4/61
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
14.8%
9/61
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
8.2%
5/61
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.6%
4/61
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
19.7%
12/61
|
|
Skin and subcutaneous tissue disorders
Exfoliative rash
|
8.2%
5/61
|
|
Skin and subcutaneous tissue disorders
Hair colour changes
|
13.1%
8/61
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
36.1%
22/61
|
|
Skin and subcutaneous tissue disorders
Periorbital oedema
|
13.1%
8/61
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.2%
5/61
|
|
Skin and subcutaneous tissue disorders
Rash
|
19.7%
12/61
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
39.3%
24/61
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
18.0%
11/61
|
|
Vascular disorders
Hypertension
|
32.8%
20/61
|
|
Vascular disorders
Hypotension
|
8.2%
5/61
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of \< 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), \< 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