Trial Outcomes & Findings for A Study of Gemcitabine, Capecitabine and Bevacizumab to Treat Cancer of the Gall Bladder or Bile Ducts (NCT NCT01007552)
NCT ID: NCT01007552
Last Updated: 2017-03-29
Results Overview
Progression will be evaluated in this study using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST 1.0). Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST criteria. Note: Lesions are either measurable or non-measurable using the criteria provided below. The term "evaluable" in reference to measurability will not be used because it does not provide additional meaning or accuracy.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years
Results posted on
2017-03-29
Participant Flow
Participant milestones
| Measure |
Gemcitabine, Capecitabine and Bevacizumab
Estimate the toxicity of the regimen, and estimate the quality of life (QOL).
Gemcitabine, Capecitabine and Bevacizumab: Bevacizumab 15 mg/ kg every 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 every 21 days.
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
COMPLETED
|
49
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Gemcitabine, Capecitabine and Bevacizumab
Estimate the toxicity of the regimen, and estimate the quality of life (QOL).
Gemcitabine, Capecitabine and Bevacizumab: Bevacizumab 15 mg/ kg every 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 every 21 days.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
A Study of Gemcitabine, Capecitabine and Bevacizumab to Treat Cancer of the Gall Bladder or Bile Ducts
Baseline characteristics by cohort
| Measure |
Gemcitabine, Capecitabine and Bevacizumab
n=50 Participants
Estimate the toxicity of the regimen, and estimate the quality of life (QOL).
Gemcitabine, Capecitabine and Bevacizumab: Bevacizumab 15 mg/ kg every 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 every 21 days.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
20 Participants
n=5 Participants
|
|
Age, Continuous
|
61.6 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 yearsPopulation: All treated and eligible patients
Progression will be evaluated in this study using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST 1.0). Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST criteria. Note: Lesions are either measurable or non-measurable using the criteria provided below. The term "evaluable" in reference to measurability will not be used because it does not provide additional meaning or accuracy.
Outcome measures
| Measure |
Gemcitabine, Capecitabine and Bevacizumab
n=50 Participants
Estimate the toxicity of the regimen, and estimate the quality of life (QOL).
Gemcitabine, Capecitabine and Bevacizumab: Bevacizumab 15 mg/ kg every 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 every 21 days.
|
|---|---|
|
The Primary Objective of This Study is to Assess Progression Free Survival (PFS) With Proposed Therapy for Patients With Locally Advanced or Metastatic Gallbladder and Biliary Cancers.
|
8.1 months
Interval 5.3 to 9.9
|
SECONDARY outcome
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 yearsPopulation: All treated and eligible patients
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Gemcitabine, Capecitabine and Bevacizumab
n=50 Participants
Estimate the toxicity of the regimen, and estimate the quality of life (QOL).
Gemcitabine, Capecitabine and Bevacizumab: Bevacizumab 15 mg/ kg every 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 every 21 days.
|
|---|---|
|
Estimate the Proportion of Patients With Clinical Response
|
24 percentage of participants
Interval 13.0 to 38.0
|
SECONDARY outcome
Timeframe: up to 5 yearsPopulation: All treated and eligible patients
Number of patients with Serious Adverse Events. Please refer to the adverse event reporting for more detail.
Outcome measures
| Measure |
Gemcitabine, Capecitabine and Bevacizumab
n=50 Participants
Estimate the toxicity of the regimen, and estimate the quality of life (QOL).
Gemcitabine, Capecitabine and Bevacizumab: Bevacizumab 15 mg/ kg every 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 every 21 days.
|
|---|---|
|
Assess the Toxicity of the Regimen.
|
30 participants
|
SECONDARY outcome
Timeframe: Baseline, Day 22 and Day 43Population: All treated and eligible patients. Some measures were not complete for leading to missing values.
We utilized the FACT-HEP TOTAL SCORE (version 4) quality-of-life scale, which is a 45 item scale ranging from 96-178. Higher scores of the reflect better quality of life. For a Detailed description see: Nancy Heffernan, David Cella, Kimberly Webster, Linda Odom, Mary Martone, Steven Passik, Marilyn Bookbinder, Yuman Fong, William Jarnagin, and Leslie Blumgart: Measuring Health-Related Quality of Life in Patients With Hepatobiliary Cancers: The Functional Assessment of Cancer Therapy-Hepatobiliary Questionnaire. Journal of Clinical Oncology, Vol 20, No 9 (May 1), 2002: pp 2229-2239. No subscales were analyzed. .
Outcome measures
| Measure |
Gemcitabine, Capecitabine and Bevacizumab
n=49 Participants
Estimate the toxicity of the regimen, and estimate the quality of life (QOL).
Gemcitabine, Capecitabine and Bevacizumab: Bevacizumab 15 mg/ kg every 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 every 21 days.
|
|---|---|
|
Assess the Change in the Quality of Life Among Patients Using the FACT-Hep (Version 4) for Hepatobiliary Cancers.
Baseline
|
136.7 units on a scale
Standard Deviation 20.8
|
|
Assess the Change in the Quality of Life Among Patients Using the FACT-Hep (Version 4) for Hepatobiliary Cancers.
Cycle 2
|
135.6 units on a scale
Standard Deviation 22.1
|
|
Assess the Change in the Quality of Life Among Patients Using the FACT-Hep (Version 4) for Hepatobiliary Cancers.
Cycle 3
|
139.9 units on a scale
Standard Deviation 16.7
|
SECONDARY outcome
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 yearsPopulation: All treated and eligible patients
Outcome measures
| Measure |
Gemcitabine, Capecitabine and Bevacizumab
n=50 Participants
Estimate the toxicity of the regimen, and estimate the quality of life (QOL).
Gemcitabine, Capecitabine and Bevacizumab: Bevacizumab 15 mg/ kg every 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 every 21 days.
|
|---|---|
|
Assess Overall Survival (OS)
|
10.2 months
Interval 7.5 to 13.7
|
SECONDARY outcome
Timeframe: baseline, day 22 and day 43Population: All treated and eligible patients
Mean number of CTCs in 7.5 ml of whole blood
Outcome measures
| Measure |
Gemcitabine, Capecitabine and Bevacizumab
n=50 Participants
Estimate the toxicity of the regimen, and estimate the quality of life (QOL).
Gemcitabine, Capecitabine and Bevacizumab: Bevacizumab 15 mg/ kg every 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 every 21 days.
|
|---|---|
|
Circulating Tumor Cells (CTC) Will be Assessed at Baseline, Day 22 and Day 43
Baseline
|
2.3 cells
Standard Deviation 0.9
|
|
Circulating Tumor Cells (CTC) Will be Assessed at Baseline, Day 22 and Day 43
Day 22
|
1.0 cells
Standard Deviation 0.4
|
|
Circulating Tumor Cells (CTC) Will be Assessed at Baseline, Day 22 and Day 43
Day 43
|
0.8 cells
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: Baseline, day 8 and day 43Population: No patients were analyzed and no data were collected for this Outcome Measure. This was an optional aim and the research team decided to opted out of analyzing.
This was a tissue banking end point of sample collection for future studies. No analysis was completed.
Outcome measures
Outcome data not reported
Adverse Events
Gemcitabine, Capecitabine and Bevacizumab
Serious events: 30 serious events
Other events: 50 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Gemcitabine, Capecitabine and Bevacizumab
n=50 participants at risk
Estimate the toxicity of the regimen, and estimate the quality of life (QOL).
Gemcitabine, Capecitabine and Bevacizumab: Bevacizumab 15 mg/ kg every 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 every 21 days.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.0%
1/50 • Number of events 3
|
|
Blood and lymphatic system disorders
Haemolytic uraemic syndrome
|
2.0%
1/50 • Number of events 3
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.0%
1/50 • Number of events 3
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.0%
1/50 • Number of events 3
|
|
Cardiac disorders
Pericarditis
|
2.0%
1/50 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal pain
|
8.0%
4/50 • Number of events 12
|
|
Gastrointestinal disorders
Colitis
|
6.0%
3/50 • Number of events 9
|
|
Gastrointestinal disorders
Constipation
|
2.0%
1/50 • Number of events 3
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
4.0%
2/50 • Number of events 6
|
|
Gastrointestinal disorders
Intestinal obstruction
|
4.0%
2/50 • Number of events 6
|
|
Gastrointestinal disorders
Large intestine perforation
|
2.0%
1/50 • Number of events 3
|
|
Gastrointestinal disorders
Nausea
|
4.0%
2/50 • Number of events 6
|
|
Gastrointestinal disorders
Varices oesophageal
|
2.0%
1/50 • Number of events 3
|
|
Gastrointestinal disorders
Vomiting
|
4.0%
2/50 • Number of events 6
|
|
General disorders
Fatigue
|
4.0%
2/50 • Number of events 6
|
|
General disorders
Pyrexia
|
8.0%
4/50 • Number of events 12
|
|
Hepatobiliary disorders
Cholangitis
|
8.0%
4/50 • Number of events 15
|
|
Hepatobiliary disorders
Cholecystitis
|
2.0%
1/50 • Number of events 3
|
|
Hepatobiliary disorders
Hepatic failure
|
2.0%
1/50 • Number of events 6
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
2.0%
1/50 • Number of events 3
|
|
Infections and infestations
Abdominal infection
|
2.0%
1/50 • Number of events 3
|
|
Infections and infestations
Bacteraemia
|
6.0%
3/50 • Number of events 12
|
|
Infections and infestations
Biliary sepsis
|
2.0%
1/50 • Number of events 6
|
|
Infections and infestations
Clostridium difficile colitis
|
2.0%
1/50 • Number of events 3
|
|
Infections and infestations
Kidney infection
|
2.0%
1/50 • Number of events 3
|
|
Infections and infestations
Liver abscess
|
2.0%
1/50 • Number of events 3
|
|
Infections and infestations
Pneumonia
|
2.0%
1/50 • Number of events 6
|
|
Infections and infestations
Sepsis
|
6.0%
3/50 • Number of events 9
|
|
Investigations
Kidney injury molecule-1
|
2.0%
1/50 • Number of events 3
|
|
Metabolism and nutrition disorders
Dehydration
|
2.0%
1/50 • Number of events 3
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
4.0%
2/50 • Number of events 6
|
|
Nervous system disorders
Cerebrovascular accident
|
2.0%
1/50 • Number of events 3
|
|
Nervous system disorders
Mental impairment
|
2.0%
1/50 • Number of events 3
|
|
Psychiatric disorders
Confusional state
|
2.0%
1/50 • Number of events 3
|
|
Renal and urinary disorders
Renal failure
|
4.0%
2/50 • Number of events 6
|
|
Renal and urinary disorders
Renal failure acute
|
2.0%
1/50 • Number of events 3
|
|
Renal and urinary disorders
Urethral stenosis
|
2.0%
1/50 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.0%
3/50 • Number of events 12
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.0%
1/50 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.0%
1/50 • Number of events 3
|
|
Vascular disorders
Deep vein thrombosis
|
2.0%
1/50 • Number of events 3
|
|
Vascular disorders
Hypertension
|
2.0%
1/50 • Number of events 3
|
|
Vascular disorders
Vascular occlusion
|
2.0%
1/50 • Number of events 3
|
Other adverse events
| Measure |
Gemcitabine, Capecitabine and Bevacizumab
n=50 participants at risk
Estimate the toxicity of the regimen, and estimate the quality of life (QOL).
Gemcitabine, Capecitabine and Bevacizumab: Bevacizumab 15 mg/ kg every 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 every 21 days.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
68.0%
34/50 • Number of events 399
|
|
Blood and lymphatic system disorders
Leukopenia
|
76.0%
38/50 • Number of events 837
|
|
Blood and lymphatic system disorders
Lymphopenia
|
68.0%
34/50 • Number of events 369
|
|
Blood and lymphatic system disorders
Neutropenia
|
58.0%
29/50 • Number of events 522
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
62.0%
31/50 • Number of events 435
|
|
Cardiac disorders
Pericardial effusion
|
4.0%
2/50 • Number of events 6
|
|
Cardiac disorders
Tachycardia
|
2.0%
1/50 • Number of events 3
|
|
Ear and labyrinth disorders
Ear pain
|
2.0%
1/50 • Number of events 3
|
|
Ear and labyrinth disorders
Vertigo
|
2.0%
1/50 • Number of events 3
|
|
Eye disorders
Abnormal sensation in eye
|
2.0%
1/50 • Number of events 3
|
|
Eye disorders
Cataract
|
2.0%
1/50 • Number of events 3
|
|
Eye disorders
Dacryostenosis acquired
|
2.0%
1/50 • Number of events 3
|
|
Eye disorders
Dry eye
|
2.0%
1/50 • Number of events 3
|
|
Eye disorders
Eye haemorrhage
|
2.0%
1/50 • Number of events 6
|
|
Eye disorders
Keratitis
|
2.0%
1/50 • Number of events 3
|
|
Eye disorders
Periorbital oedema
|
2.0%
1/50 • Number of events 3
|
|
Eye disorders
Photophobia
|
4.0%
2/50 • Number of events 6
|
|
Eye disorders
Vision blurred
|
12.0%
6/50 • Number of events 21
|
|
Eye disorders
Vitreous floaters
|
2.0%
1/50 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal discomfort
|
2.0%
1/50 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal distension
|
20.0%
10/50 • Number of events 36
|
|
Gastrointestinal disorders
Abdominal pain
|
40.0%
20/50 • Number of events 84
|
|
Gastrointestinal disorders
Abdominal pain lower
|
4.0%
2/50 • Number of events 9
|
|
Gastrointestinal disorders
Abdominal pain upper
|
10.0%
5/50 • Number of events 21
|
|
Gastrointestinal disorders
Anal fissure
|
2.0%
1/50 • Number of events 6
|
|
Gastrointestinal disorders
Anal haemorrhage
|
2.0%
1/50 • Number of events 3
|
|
Gastrointestinal disorders
Ascites
|
18.0%
9/50 • Number of events 54
|
|
Gastrointestinal disorders
Cheilitis
|
2.0%
1/50 • Number of events 3
|
|
Gastrointestinal disorders
Colitis
|
2.0%
1/50 • Number of events 6
|
|
Gastrointestinal disorders
Constipation
|
48.0%
24/50 • Number of events 129
|
|
Gastrointestinal disorders
Diarrhoea
|
46.0%
23/50 • Number of events 273
|
|
Gastrointestinal disorders
Dry mouth
|
16.0%
8/50 • Number of events 24
|
|
Gastrointestinal disorders
Dyspepsia
|
20.0%
10/50 • Number of events 36
|
|
Gastrointestinal disorders
Faecal incontinence
|
2.0%
1/50 • Number of events 3
|
|
Gastrointestinal disorders
Flatulence
|
8.0%
4/50 • Number of events 27
|
|
Gastrointestinal disorders
Gingival bleeding
|
2.0%
1/50 • Number of events 3
|
|
Gastrointestinal disorders
Glossodynia
|
2.0%
1/50 • Number of events 3
|
|
Gastrointestinal disorders
Haematochezia
|
6.0%
3/50 • Number of events 9
|
|
Gastrointestinal disorders
Intestinal perforation
|
2.0%
1/50 • Number of events 3
|
|
Gastrointestinal disorders
Loose tooth
|
2.0%
1/50 • Number of events 3
|
|
Gastrointestinal disorders
Nausea
|
62.0%
31/50 • Number of events 378
|
|
Gastrointestinal disorders
Stomatitis
|
34.0%
17/50 • Number of events 84
|
|
Gastrointestinal disorders
Vomiting
|
44.0%
22/50 • Number of events 210
|
|
General disorders
Asthenia
|
14.0%
7/50 • Number of events 27
|
|
General disorders
Chest pain
|
6.0%
3/50 • Number of events 9
|
|
General disorders
Chills
|
34.0%
17/50 • Number of events 126
|
|
General disorders
Fatigue
|
80.0%
40/50 • Number of events 362
|
|
General disorders
Gait disturbance
|
4.0%
2/50 • Number of events 6
|
|
General disorders
Generalised oedema
|
2.0%
1/50 • Number of events 6
|
|
General disorders
Influenza like illness
|
10.0%
5/50 • Number of events 18
|
|
General disorders
Injection site rash
|
2.0%
1/50 • Number of events 3
|
|
General disorders
Localised oedema
|
4.0%
2/50 • Number of events 6
|
|
General disorders
Mucosal inflammation
|
24.0%
12/50 • Number of events 84
|
|
General disorders
Non-cardiac chest pain
|
4.0%
2/50 • Number of events 9
|
|
General disorders
Oedema
|
8.0%
4/50 • Number of events 21
|
|
General disorders
Oedema peripheral
|
48.0%
24/50 • Number of events 129
|
|
General disorders
Pain
|
6.0%
3/50 • Number of events 12
|
|
General disorders
Pyrexia
|
38.0%
19/50 • Number of events 243
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
38.0%
19/50 • Number of events 144
|
|
Infections and infestations
Bacteraemia
|
2.0%
1/50 • Number of events 3
|
|
Infections and infestations
Bacterial infection
|
2.0%
1/50 • Number of events 3
|
|
Infections and infestations
Bronchitis
|
2.0%
1/50 • Number of events 3
|
|
Infections and infestations
Candidiasis
|
2.0%
1/50 • Number of events 3
|
|
Infections and infestations
Cellulitis
|
10.0%
5/50 • Number of events 24
|
|
Infections and infestations
Fungal infection
|
2.0%
1/50 • Number of events 3
|
|
Infections and infestations
Gingival infection
|
2.0%
1/50 • Number of events 3
|
|
Infections and infestations
Infection
|
10.0%
5/50 • Number of events 15
|
|
Infections and infestations
Laryngitis
|
2.0%
1/50 • Number of events 3
|
|
Infections and infestations
Liver abscess
|
2.0%
1/50 • Number of events 3
|
|
Infections and infestations
Nasopharyngitis
|
2.0%
1/50 • Number of events 3
|
|
Infections and infestations
Pneumonia
|
2.0%
1/50 • Number of events 3
|
|
Infections and infestations
Pneumonia klebsiella
|
2.0%
1/50 • Number of events 3
|
|
Infections and infestations
Rhinitis
|
6.0%
3/50 • Number of events 9
|
|
Infections and infestations
Sinusitis
|
4.0%
2/50 • Number of events 6
|
|
Infections and infestations
Tooth abscess
|
2.0%
1/50 • Number of events 3
|
|
Infections and infestations
Upper respiratory tract infection
|
4.0%
2/50 • Number of events 6
|
|
Infections and infestations
Urinary tract infection
|
12.0%
6/50 • Number of events 18
|
|
Injury, poisoning and procedural complications
Contusion
|
6.0%
3/50 • Number of events 9
|
|
Injury, poisoning and procedural complications
Fall
|
4.0%
2/50 • Number of events 9
|
|
Injury, poisoning and procedural complications
Joint injury
|
2.0%
1/50 • Number of events 3
|
|
Investigations
Alanine aminotransferase increased
|
64.0%
32/50 • Number of events 363
|
|
Investigations
Aspartate aminotransferase increased
|
68.0%
34/50 • Number of events 369
|
|
Investigations
Blood albumin decreased
|
2.0%
1/50 • Number of events 6
|
|
Investigations
Blood alkaline phosphatase
|
2.0%
1/50 • Number of events 3
|
|
Investigations
Blood alkaline phosphatase increased
|
44.0%
22/50 • Number of events 153
|
|
Investigations
Blood amylase increased
|
2.0%
1/50 • Number of events 3
|
|
Investigations
Blood bilirubin increased
|
2.0%
1/50 • Number of events 3
|
|
Investigations
Blood calcium decreased
|
2.0%
1/50 • Number of events 3
|
|
Investigations
Blood creatinine increased
|
30.0%
15/50 • Number of events 117
|
|
Investigations
Blood potassium decreased
|
2.0%
1/50 • Number of events 6
|
|
Investigations
Blood urea increased
|
2.0%
1/50 • Number of events 3
|
|
Investigations
Heart rate irregular
|
2.0%
1/50 • Number of events 3
|
|
Investigations
International normalised ratio increased
|
10.0%
5/50 • Number of events 39
|
|
Investigations
Neutrophil count decreased
|
4.0%
2/50 • Number of events 9
|
|
Investigations
Platelet count decreased
|
2.0%
1/50 • Number of events 3
|
|
Investigations
Troponin I increased
|
2.0%
1/50 • Number of events 3
|
|
Investigations
Weight decreased
|
28.0%
14/50 • Number of events 60
|
|
Investigations
Weight increased
|
4.0%
2/50 • Number of events 9
|
|
Investigations
White blood cell count decreased
|
2.0%
1/50 • Number of events 3
|
|
Metabolism and nutrition disorders
Decreased appetite
|
46.0%
23/50 • Number of events 105
|
|
Metabolism and nutrition disorders
Dehydration
|
10.0%
5/50 • Number of events 15
|
|
Metabolism and nutrition disorders
Hyperalbuminaemia
|
4.0%
2/50 • Number of events 6
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
2.0%
1/50 • Number of events 6
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
38.0%
19/50 • Number of events 345
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
16.0%
8/50 • Number of events 48
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
4.0%
2/50 • Number of events 12
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
66.0%
33/50 • Number of events 399
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
44.0%
22/50 • Number of events 165
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
2.0%
1/50 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
34.0%
17/50 • Number of events 93
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
68.0%
34/50 • Number of events 303
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
2.0%
1/50 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
2.0%
1/50 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
22.0%
11/50 • Number of events 66
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
4.0%
2/50 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.0%
8/50 • Number of events 30
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
8.0%
4/50 • Number of events 12
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.0%
3/50 • Number of events 15
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
28.0%
14/50 • Number of events 60
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
2.0%
1/50 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
4.0%
2/50 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.0%
3/50 • Number of events 12
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
4.0%
2/50 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
14.0%
7/50 • Number of events 24
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
4.0%
2/50 • Number of events 6
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leiomyoma
|
2.0%
1/50 • Number of events 3
|
|
Nervous system disorders
Dizziness
|
36.0%
18/50 • Number of events 54
|
|
Nervous system disorders
Dysgeusia
|
36.0%
18/50 • Number of events 81
|
|
Nervous system disorders
Headache
|
32.0%
16/50 • Number of events 72
|
|
Nervous system disorders
Hypoaesthesia
|
10.0%
5/50 • Number of events 21
|
|
Nervous system disorders
Leukoencephalopathy
|
2.0%
1/50 • Number of events 3
|
|
Nervous system disorders
Neuropathy peripheral
|
18.0%
9/50 • Number of events 33
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
8.0%
4/50 • Number of events 12
|
|
Nervous system disorders
Restless legs syndrome
|
2.0%
1/50 • Number of events 3
|
|
Nervous system disorders
Sinus headache
|
8.0%
4/50 • Number of events 21
|
|
Nervous system disorders
Somnolence
|
4.0%
2/50 • Number of events 6
|
|
Nervous system disorders
Tardive dyskinesia
|
2.0%
1/50 • Number of events 3
|
|
Psychiatric disorders
Anxiety
|
20.0%
10/50 • Number of events 36
|
|
Psychiatric disorders
Confusional state
|
6.0%
3/50 • Number of events 15
|
|
Psychiatric disorders
Depression
|
28.0%
14/50 • Number of events 66
|
|
Psychiatric disorders
Hallucination
|
2.0%
1/50 • Number of events 6
|
|
Psychiatric disorders
Insomnia
|
28.0%
14/50 • Number of events 57
|
|
Psychiatric disorders
Mental status changes
|
6.0%
3/50 • Number of events 9
|
|
Renal and urinary disorders
Bladder spasm
|
2.0%
1/50 • Number of events 3
|
|
Renal and urinary disorders
Haematuria
|
2.0%
1/50 • Number of events 3
|
|
Renal and urinary disorders
Micturition urgency
|
2.0%
1/50 • Number of events 3
|
|
Renal and urinary disorders
Pollakiuria
|
2.0%
1/50 • Number of events 3
|
|
Renal and urinary disorders
Proteinuria
|
6.0%
3/50 • Number of events 48
|
|
Renal and urinary disorders
Urinary retention
|
4.0%
2/50 • Number of events 9
|
|
Reproductive system and breast disorders
Pelvic pain
|
2.0%
1/50 • Number of events 12
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
2.0%
1/50 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
2.0%
1/50 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Choking sensation
|
2.0%
1/50 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
24.0%
12/50 • Number of events 45
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
2.0%
1/50 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
12.0%
6/50 • Number of events 21
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
56.0%
28/50 • Number of events 126
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
4.0%
2/50 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
38.0%
19/50 • Number of events 78
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
4.0%
2/50 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.0%
2/50 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
8.0%
4/50 • Number of events 24
|
|
Respiratory, thoracic and mediastinal disorders
Nasal disorder
|
2.0%
1/50 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum perforation
|
4.0%
2/50 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
12.0%
6/50 • Number of events 21
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
8.0%
4/50 • Number of events 12
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
2.0%
1/50 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
10.0%
5/50 • Number of events 15
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary thrombosis
|
2.0%
1/50 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
10.0%
5/50 • Number of events 18
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
2.0%
1/50 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
12.0%
6/50 • Number of events 21
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
4.0%
2/50 • Number of events 9
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
2.0%
1/50 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
2.0%
1/50 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
20.0%
10/50 • Number of events 30
|
|
Skin and subcutaneous tissue disorders
Erythema
|
6.0%
3/50 • Number of events 9
|
|
Skin and subcutaneous tissue disorders
Exfoliative rash
|
2.0%
1/50 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
14.0%
7/50 • Number of events 27
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
14.0%
7/50 • Number of events 21
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
16.0%
8/50 • Number of events 30
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
2.0%
1/50 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
50.0%
25/50 • Number of events 132
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
2.0%
1/50 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.0%
7/50 • Number of events 42
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
2.0%
1/50 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Rash
|
24.0%
12/50 • Number of events 69
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
2.0%
1/50 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
2.0%
1/50 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
2.0%
1/50 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
2.0%
1/50 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
24.0%
12/50 • Number of events 36
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
2.0%
1/50 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Systemic lupus erythematosus rash
|
2.0%
1/50 • Number of events 3
|
|
Surgical and medical procedures
Cataract operation
|
2.0%
1/50 • Number of events 3
|
|
Surgical and medical procedures
Sinus operation
|
2.0%
1/50 • Number of events 3
|
|
Vascular disorders
Deep vein thrombosis
|
4.0%
2/50 • Number of events 9
|
|
Vascular disorders
Embolism arterial
|
2.0%
1/50 • Number of events 3
|
|
Vascular disorders
Flushing
|
2.0%
1/50 • Number of events 3
|
|
Vascular disorders
Haematoma
|
2.0%
1/50 • Number of events 3
|
|
Vascular disorders
Hot flush
|
2.0%
1/50 • Number of events 3
|
|
Vascular disorders
Hypertension
|
28.0%
14/50 • Number of events 90
|
|
Vascular disorders
Hypotension
|
12.0%
6/50 • Number of events 21
|
|
Vascular disorders
Thrombosis
|
2.0%
1/50 • Number of events 3
|
Additional Information
Senior Administrator, Compliance - Clinical Research Services
Roswell Park Cancer Institute
Phone: 716-845-2300
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place