Trial Outcomes & Findings for Gemcitabine, Capecitabine, and Bevacizumab in Treating Patients With Metastatic or Unresectable Pancreatic Cancer (NCT NCT00100815)
NCT ID: NCT00100815
Last Updated: 2015-12-24
Results Overview
Progressive Disease is defined using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee \[JNCI 92(3):205-216, 2000\], as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions, or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
every 2-4 months for 1 year and then every 6 months for 5 years
Results posted on
2015-12-24
Participant Flow
Participant milestones
| Measure |
GEMCITABINE, CAPECITABINE and AVASTIN
Avastin 15 mg/ kg q 3 weeks, starting day 1; capecitabine 650 mg/m2 bid x 14 days starting day 1, gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated q 21 days.
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
49
|
Reasons for withdrawal
| Measure |
GEMCITABINE, CAPECITABINE and AVASTIN
Avastin 15 mg/ kg q 3 weeks, starting day 1; capecitabine 650 mg/m2 bid x 14 days starting day 1, gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated q 21 days.
|
|---|---|
|
Overall Study
Progression
|
24
|
|
Overall Study
Adverse Event
|
18
|
|
Overall Study
Death
|
4
|
|
Overall Study
Other
|
3
|
Baseline Characteristics
Gemcitabine, Capecitabine, and Bevacizumab in Treating Patients With Metastatic or Unresectable Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
GEMCITABINE, CAPECITABINE and AVASTIN
n=50 Participants
Avastin 15 mg/ kg q 3 weeks, starting day 1; capecitabine 650 mg/m2 bid x 14 days starting day 1, gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated q 21 days.
|
|---|---|
|
Age, Continuous
|
64.18 years
STANDARD_DEVIATION 11.62 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: every 2-4 months for 1 year and then every 6 months for 5 yearsPopulation: All treated and eligible patients
Progressive Disease is defined using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee \[JNCI 92(3):205-216, 2000\], as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions, or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
Outcome measures
| Measure |
GEMCITABINE, CAPECITABINE and AVASTIN
n=50 Participants
Avastin 15 mg/ kg q 3 weeks, starting day 1; capecitabine 650 mg/m2 bid x 14 days starting day 1, gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated q 21 days.
|
|---|---|
|
Progression-free Survival
|
5.7 months
Interval 4.2 to 7.2
|
SECONDARY outcome
Timeframe: Subjects were evaluated for adverse events at each study visit for the duration of their participation in the study, up to 5 yearsPopulation: All treated and eligible patients
Grade 3, 4 or 5 toxicity rate
Outcome measures
| Measure |
GEMCITABINE, CAPECITABINE and AVASTIN
n=50 Participants
Avastin 15 mg/ kg q 3 weeks, starting day 1; capecitabine 650 mg/m2 bid x 14 days starting day 1, gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated q 21 days.
|
|---|---|
|
Percentage of Participants With Grades 3-5 Treatment Related Toxicities
|
70 percentage of participants
Interval 55.4 to 82.1
|
SECONDARY outcome
Timeframe: assessed at baseline then weekly for 3 weeksPopulation: All treated and eligible patients
Quality of Life was assessed using EORTC QLQ-PAN26. All measures range in score from 1 to 4 as lower scores indicate better outcomes. The improved Quality of Life is defined as a greater than 5% decrease in 2 consecutive scores compared with the baseline score.
Outcome measures
| Measure |
GEMCITABINE, CAPECITABINE and AVASTIN
n=50 Participants
Avastin 15 mg/ kg q 3 weeks, starting day 1; capecitabine 650 mg/m2 bid x 14 days starting day 1, gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated q 21 days.
|
|---|---|
|
Percentage of Participants With Improved Quality of Life
|
56.0 percentage of participants
Interval 41.3 to 70.0
|
SECONDARY outcome
Timeframe: Pre-treatment and every 6 weeks from treatment.Population: All treated and eligible patients
Response was evaluated using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee \[JNCI 92(3):205-216, 2000\]. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
GEMCITABINE, CAPECITABINE and AVASTIN
n=50 Participants
Avastin 15 mg/ kg q 3 weeks, starting day 1; capecitabine 650 mg/m2 bid x 14 days starting day 1, gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated q 21 days.
|
|---|---|
|
Clinical Response
|
22.0 percentage of participants
Interval 11.5 to 35.9
|
SECONDARY outcome
Timeframe: every 2-4 months for 1 year and then every 6 months for 5 yearsPopulation: All treated and eligible patients
Outcome measures
| Measure |
GEMCITABINE, CAPECITABINE and AVASTIN
n=50 Participants
Avastin 15 mg/ kg q 3 weeks, starting day 1; capecitabine 650 mg/m2 bid x 14 days starting day 1, gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated q 21 days.
|
|---|---|
|
Overall Survival
|
9.8 months
Interval 8.3 to 12.6
|
Adverse Events
GEMCITABINE, CAPECITABINE and AVASTIN
Serious events: 27 serious events
Other events: 47 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GEMCITABINE, CAPECITABINE and AVASTIN
n=50 participants at risk
Avastin 15 mg/ kg q 3 weeks, starting day 1; capecitabine 650 mg/m2 bid x 14 days starting day 1, gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated q 21 days.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
4.0%
2/50 • Number of events 2
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.0%
3/50 • Number of events 3
|
|
Cardiac disorders
Myocardial infarction
|
2.0%
1/50 • Number of events 1
|
|
Eye disorders
Blindness
|
2.0%
1/50 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
8.0%
4/50 • Number of events 4
|
|
Gastrointestinal disorders
Constipation
|
2.0%
1/50 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
4.0%
2/50 • Number of events 2
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
2.0%
1/50 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
6.0%
3/50 • Number of events 5
|
|
Gastrointestinal disorders
Gastrointestinal ulcer haemorrhage
|
2.0%
1/50 • Number of events 1
|
|
Gastrointestinal disorders
Intestinal obstruction
|
2.0%
1/50 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
2.0%
1/50 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
6.0%
3/50 • Number of events 5
|
|
General disorders
Asthenia
|
2.0%
1/50 • Number of events 1
|
|
General disorders
Death
|
10.0%
5/50 • Number of events 5
|
|
General disorders
Device occlusion
|
2.0%
1/50 • Number of events 1
|
|
General disorders
Fatigue
|
2.0%
1/50 • Number of events 1
|
|
General disorders
Mucosal inflammation
|
2.0%
1/50 • Number of events 1
|
|
General disorders
Pain
|
6.0%
3/50 • Number of events 3
|
|
General disorders
Pyrexia
|
10.0%
5/50 • Number of events 6
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
2.0%
1/50 • Number of events 1
|
|
Infections and infestations
Clostridium difficile colitis
|
2.0%
1/50 • Number of events 1
|
|
Infections and infestations
Diverticulitis
|
2.0%
1/50 • Number of events 1
|
|
Infections and infestations
Febrile infection
|
2.0%
1/50 • Number of events 1
|
|
Infections and infestations
Infection
|
2.0%
1/50 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
4.0%
2/50 • Number of events 2
|
|
Infections and infestations
Sepsis
|
4.0%
2/50 • Number of events 2
|
|
Investigations
Aspartate aminotransferase increased
|
2.0%
1/50 • Number of events 1
|
|
Investigations
Blood alkaline phosphatase increased
|
2.0%
1/50 • Number of events 2
|
|
Investigations
Haemoglobin
|
2.0%
1/50 • Number of events 1
|
|
Investigations
Neutrophil count
|
2.0%
1/50 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
8.0%
4/50 • Number of events 4
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.0%
1/50 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.0%
2/50 • Number of events 2
|
|
Nervous system disorders
Balance disorder
|
2.0%
1/50 • Number of events 1
|
|
Nervous system disorders
Headache
|
2.0%
1/50 • Number of events 1
|
|
Psychiatric disorders
Confusional state
|
2.0%
1/50 • Number of events 1
|
|
Renal and urinary disorders
Haematuria
|
2.0%
1/50 • Number of events 1
|
|
Reproductive system and breast disorders
Female genital tract fistula
|
2.0%
1/50 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.0%
2/50 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
2.0%
1/50 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
4.0%
2/50 • Number of events 2
|
|
Vascular disorders
Deep vein thrombosis
|
4.0%
2/50 • Number of events 2
|
|
Vascular disorders
Haemorrhage
|
2.0%
1/50 • Number of events 1
|
|
Vascular disorders
Hypertension
|
2.0%
1/50 • Number of events 1
|
|
Vascular disorders
Thrombophlebitis superficial
|
2.0%
1/50 • Number of events 1
|
Other adverse events
| Measure |
GEMCITABINE, CAPECITABINE and AVASTIN
n=50 participants at risk
Avastin 15 mg/ kg q 3 weeks, starting day 1; capecitabine 650 mg/m2 bid x 14 days starting day 1, gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated q 21 days.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
36.0%
18/50 • Number of events 29
|
|
Blood and lymphatic system disorders
Leukopenia
|
12.0%
6/50 • Number of events 9
|
|
Blood and lymphatic system disorders
Lymphopenia
|
6.0%
3/50 • Number of events 4
|
|
Blood and lymphatic system disorders
Neutropenia
|
32.0%
16/50 • Number of events 31
|
|
Blood and lymphatic system disorders
Spleen disorder
|
2.0%
1/50 • Number of events 1
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
14.0%
7/50 • Number of events 16
|
|
Cardiac disorders
Arrhythmia
|
2.0%
1/50 • Number of events 1
|
|
Cardiac disorders
Cardiomegaly
|
2.0%
1/50 • Number of events 1
|
|
Cardiac disorders
Tachycardia
|
2.0%
1/50 • Number of events 1
|
|
Ear and labyrinth disorders
Ear pain
|
2.0%
1/50 • Number of events 1
|
|
Ear and labyrinth disorders
Tinnitus
|
2.0%
1/50 • Number of events 1
|
|
Eye disorders
Eye swelling
|
2.0%
1/50 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal distension
|
4.0%
2/50 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal pain
|
26.0%
13/50 • Number of events 14
|
|
Gastrointestinal disorders
Abdominal pain lower
|
2.0%
1/50 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.0%
1/50 • Number of events 1
|
|
Gastrointestinal disorders
Chapped lips
|
2.0%
1/50 • Number of events 1
|
|
Gastrointestinal disorders
Colitis
|
6.0%
3/50 • Number of events 3
|
|
Gastrointestinal disorders
Constipation
|
26.0%
13/50 • Number of events 16
|
|
Gastrointestinal disorders
Diarrhoea
|
34.0%
17/50 • Number of events 24
|
|
Gastrointestinal disorders
Dry mouth
|
4.0%
2/50 • Number of events 2
|
|
Gastrointestinal disorders
Dyspepsia
|
2.0%
1/50 • Number of events 1
|
|
Gastrointestinal disorders
Dysphagia
|
6.0%
3/50 • Number of events 3
|
|
Gastrointestinal disorders
Faecaloma
|
2.0%
1/50 • Number of events 1
|
|
Gastrointestinal disorders
Faeces discoloured
|
2.0%
1/50 • Number of events 1
|
|
Gastrointestinal disorders
Flatulence
|
6.0%
3/50 • Number of events 3
|
|
Gastrointestinal disorders
Gastric varices
|
2.0%
1/50 • Number of events 1
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.0%
1/50 • Number of events 1
|
|
Gastrointestinal disorders
Gingival bleeding
|
2.0%
1/50 • Number of events 1
|
|
Gastrointestinal disorders
Gingival polyp
|
2.0%
1/50 • Number of events 1
|
|
Gastrointestinal disorders
Glossodynia
|
2.0%
1/50 • Number of events 1
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
2.0%
1/50 • Number of events 1
|
|
Gastrointestinal disorders
Haemorrhoids
|
2.0%
1/50 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
42.0%
21/50 • Number of events 28
|
|
Gastrointestinal disorders
Oesophagitis
|
2.0%
1/50 • Number of events 1
|
|
Gastrointestinal disorders
Oral pain
|
10.0%
5/50 • Number of events 6
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
2.0%
1/50 • Number of events 1
|
|
Gastrointestinal disorders
Stomatitis
|
14.0%
7/50 • Number of events 13
|
|
Gastrointestinal disorders
Toothache
|
2.0%
1/50 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
22.0%
11/50 • Number of events 12
|
|
General disorders
Asthenia
|
8.0%
4/50 • Number of events 5
|
|
General disorders
Chest pain
|
6.0%
3/50 • Number of events 3
|
|
General disorders
Chills
|
14.0%
7/50 • Number of events 7
|
|
General disorders
Device occlusion
|
8.0%
4/50 • Number of events 4
|
|
General disorders
Fatigue
|
60.0%
30/50 • Number of events 44
|
|
General disorders
Influenza like illness
|
4.0%
2/50 • Number of events 2
|
|
General disorders
Local swelling
|
2.0%
1/50 • Number of events 1
|
|
General disorders
Mucosal inflammation
|
6.0%
3/50 • Number of events 3
|
|
General disorders
Oedema
|
22.0%
11/50 • Number of events 15
|
|
General disorders
Oedema peripheral
|
8.0%
4/50 • Number of events 5
|
|
General disorders
Pain
|
24.0%
12/50 • Number of events 14
|
|
General disorders
Pyrexia
|
18.0%
9/50 • Number of events 14
|
|
Hepatobiliary disorders
Bile duct obstruction
|
2.0%
1/50 • Number of events 1
|
|
Hepatobiliary disorders
Cholangitis
|
2.0%
1/50 • Number of events 1
|
|
Hepatobiliary disorders
Cholelithiasis
|
2.0%
1/50 • Number of events 1
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
2.0%
1/50 • Number of events 3
|
|
Infections and infestations
Cellulitis
|
2.0%
1/50 • Number of events 1
|
|
Infections and infestations
Cystitis
|
2.0%
1/50 • Number of events 1
|
|
Infections and infestations
Device related infection
|
2.0%
1/50 • Number of events 1
|
|
Infections and infestations
Infection
|
4.0%
2/50 • Number of events 2
|
|
Infections and infestations
Influenza
|
4.0%
2/50 • Number of events 2
|
|
Infections and infestations
Pneumonia
|
2.0%
1/50 • Number of events 1
|
|
Infections and infestations
Sinusitis
|
2.0%
1/50 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fall
|
2.0%
1/50 • Number of events 1
|
|
Injury, poisoning and procedural complications
Limb injury
|
2.0%
1/50 • Number of events 2
|
|
Injury, poisoning and procedural complications
Wound complication
|
2.0%
1/50 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
22.0%
11/50 • Number of events 18
|
|
Investigations
Antineutrophil cytoplasmic antibody
|
2.0%
1/50 • Number of events 1
|
|
Investigations
Aspartate aminotransferase increased
|
26.0%
13/50 • Number of events 25
|
|
Investigations
Blood albumin
|
30.0%
15/50 • Number of events 18
|
|
Investigations
Blood albumin decreased
|
8.0%
4/50 • Number of events 4
|
|
Investigations
Blood alkaline phosphatase
|
32.0%
16/50 • Number of events 31
|
|
Investigations
Blood alkaline phosphatase increased
|
6.0%
3/50 • Number of events 3
|
|
Investigations
Blood amylase increased
|
2.0%
1/50 • Number of events 1
|
|
Investigations
Blood bicarbonate
|
12.0%
6/50 • Number of events 6
|
|
Investigations
Blood bilirubin
|
20.0%
10/50 • Number of events 18
|
|
Investigations
Blood bilirubin increased
|
2.0%
1/50 • Number of events 2
|
|
Investigations
Blood calcium
|
16.0%
8/50 • Number of events 10
|
|
Investigations
Blood chloride
|
10.0%
5/50 • Number of events 6
|
|
Investigations
Blood creatinine
|
14.0%
7/50 • Number of events 7
|
|
Investigations
Blood creatinine decreased
|
2.0%
1/50 • Number of events 1
|
|
Investigations
Blood creatinine increased
|
2.0%
1/50 • Number of events 1
|
|
Investigations
Blood glucose
|
12.0%
6/50 • Number of events 18
|
|
Investigations
Blood lactate dehydrogenase
|
8.0%
4/50 • Number of events 5
|
|
Investigations
Blood lactate dehydrogenase increased
|
2.0%
1/50 • Number of events 1
|
|
Investigations
Blood potassium
|
24.0%
12/50 • Number of events 19
|
|
Investigations
Blood potassium increased
|
2.0%
1/50 • Number of events 1
|
|
Investigations
Blood pressure
|
12.0%
6/50 • Number of events 8
|
|
Investigations
Blood sodium
|
14.0%
7/50 • Number of events 8
|
|
Investigations
Blood urea
|
12.0%
6/50 • Number of events 6
|
|
Investigations
Blood uric acid decreased
|
8.0%
4/50 • Number of events 5
|
|
Investigations
Blood uric acid increased
|
8.0%
4/50 • Number of events 4
|
|
Investigations
Carbon dioxide abnormal
|
2.0%
1/50 • Number of events 1
|
|
Investigations
Creatinine renal clearance
|
2.0%
1/50 • Number of events 2
|
|
Investigations
Haematocrit
|
12.0%
6/50 • Number of events 7
|
|
Investigations
Haemoglobin
|
40.0%
20/50 • Number of events 30
|
|
Investigations
Haemoglobin decreased
|
4.0%
2/50 • Number of events 2
|
|
Investigations
International normalised ratio
|
8.0%
4/50 • Number of events 5
|
|
Investigations
International normalised ratio increased
|
2.0%
1/50 • Number of events 1
|
|
Investigations
Lipase
|
2.0%
1/50 • Number of events 1
|
|
Investigations
Liver function test
|
2.0%
1/50 • Number of events 1
|
|
Investigations
Lymphocyte count
|
2.0%
1/50 • Number of events 2
|
|
Investigations
Lymphocyte count abnormal
|
2.0%
1/50 • Number of events 1
|
|
Investigations
Neutrophil count
|
34.0%
17/50 • Number of events 31
|
|
Investigations
Neutrophil count decreased
|
2.0%
1/50 • Number of events 1
|
|
Investigations
Platelet count
|
26.0%
13/50 • Number of events 20
|
|
Investigations
Platelet count decreased
|
10.0%
5/50 • Number of events 6
|
|
Investigations
Platelet count increased
|
4.0%
2/50 • Number of events 3
|
|
Investigations
Protein total
|
8.0%
4/50 • Number of events 5
|
|
Investigations
Protein total decreased
|
6.0%
3/50 • Number of events 3
|
|
Investigations
Protein urine
|
2.0%
1/50 • Number of events 1
|
|
Investigations
Prothrombin time prolonged
|
2.0%
1/50 • Number of events 1
|
|
Investigations
Red blood cell count
|
22.0%
11/50 • Number of events 14
|
|
Investigations
Urine output increased
|
2.0%
1/50 • Number of events 1
|
|
Investigations
Weight
|
2.0%
1/50 • Number of events 1
|
|
Investigations
Weight decreased
|
26.0%
13/50 • Number of events 17
|
|
Investigations
White blood cell count
|
32.0%
16/50 • Number of events 22
|
|
Investigations
White blood cell count abnormal
|
2.0%
1/50 • Number of events 1
|
|
Investigations
White blood cell count decreased
|
10.0%
5/50 • Number of events 6
|
|
Investigations
White blood cell count increased
|
4.0%
2/50 • Number of events 2
|
|
Metabolism and nutrition disorders
Decreased appetite
|
32.0%
16/50 • Number of events 18
|
|
Metabolism and nutrition disorders
Dehydration
|
14.0%
7/50 • Number of events 9
|
|
Metabolism and nutrition disorders
Hyperalbuminaemia
|
2.0%
1/50 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
42.0%
21/50 • Number of events 30
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
10.0%
5/50 • Number of events 6
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
4.0%
2/50 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
10.0%
5/50 • Number of events 16
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
4.0%
2/50 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
8.0%
4/50 • Number of events 4
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
8.0%
4/50 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.0%
1/50 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.0%
6/50 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.0%
1/50 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
2.0%
1/50 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
2.0%
1/50 • Number of events 1
|
|
Nervous system disorders
Ageusia
|
2.0%
1/50 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
18.0%
9/50 • Number of events 9
|
|
Nervous system disorders
Dysarthria
|
2.0%
1/50 • Number of events 1
|
|
Nervous system disorders
Dysgeusia
|
2.0%
1/50 • Number of events 1
|
|
Nervous system disorders
Headache
|
8.0%
4/50 • Number of events 5
|
|
Nervous system disorders
Neuropathy peripheral
|
2.0%
1/50 • Number of events 1
|
|
Nervous system disorders
Paraesthesia
|
2.0%
1/50 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
2.0%
1/50 • Number of events 1
|
|
Psychiatric disorders
Depressed mood
|
2.0%
1/50 • Number of events 1
|
|
Psychiatric disorders
Depression
|
6.0%
3/50 • Number of events 3
|
|
Psychiatric disorders
Dysphoria
|
4.0%
2/50 • Number of events 2
|
|
Psychiatric disorders
Insomnia
|
8.0%
4/50 • Number of events 5
|
|
Psychiatric disorders
Restlessness
|
2.0%
1/50 • Number of events 1
|
|
Renal and urinary disorders
Micturition urgency
|
2.0%
1/50 • Number of events 1
|
|
Renal and urinary disorders
Nephrotic syndrome
|
2.0%
1/50 • Number of events 1
|
|
Renal and urinary disorders
Pollakiuria
|
4.0%
2/50 • Number of events 2
|
|
Renal and urinary disorders
Proteinuria
|
4.0%
2/50 • Number of events 3
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
2.0%
1/50 • Number of events 1
|
|
Reproductive system and breast disorders
Pelvic pain
|
2.0%
1/50 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.0%
3/50 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
4.0%
2/50 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.0%
8/50 • Number of events 11
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
10.0%
5/50 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
4.0%
2/50 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
2.0%
1/50 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.0%
1/50 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus discomfort
|
2.0%
1/50 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.0%
1/50 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
2.0%
1/50 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
4.0%
2/50 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
2.0%
1/50 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
2.0%
1/50 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.0%
2/50 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.0%
1/50 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.0%
1/50 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
2.0%
1/50 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
16.0%
8/50 • Number of events 14
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.0%
1/50 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.0%
6/50 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
2.0%
1/50 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Yellow skin
|
2.0%
1/50 • Number of events 1
|
|
Vascular disorders
Deep vein thrombosis
|
4.0%
2/50 • Number of events 2
|
|
Vascular disorders
Hot flush
|
2.0%
1/50 • Number of events 1
|
|
Vascular disorders
Hypertension
|
32.0%
16/50 • Number of events 27
|
|
Vascular disorders
Hypotension
|
10.0%
5/50 • Number of events 6
|
|
Vascular disorders
Orthostatic hypotension
|
6.0%
3/50 • Number of events 3
|
|
Vascular disorders
Phlebitis
|
2.0%
1/50 • Number of events 1
|
|
Vascular disorders
Subclavian vein thrombosis
|
2.0%
1/50 • Number of events 1
|
Additional Information
Senior Administrator, Compliance - Clinical Research Services
Roswell Park Cancer Institute
Phone: 716-845-2300
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place