Trial Outcomes & Findings for Erlotinib and Radiation Therapy in Treating Older Patients With Stage I, Stage II, Stage III, or Stage IV Esophageal Cancer (NCT NCT00524121)
NCT ID: NCT00524121
Last Updated: 2016-04-14
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
22 participants
Primary outcome timeframe
5 years
Results posted on
2016-04-14
Participant Flow
Participant milestones
| Measure |
Erlotinib in Combination With Radiotherapy
Erlotinib (150 mg) administered orally once daily starting day 1 and continued with radiotherapy (RT) and through day 365 (one year therapy duration). RT will be administered day 1-28 (Mon-Fri) in dose of 1.8 Gy per fraction.
|
|---|---|
|
Overall Study
STARTED
|
22
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
19
|
Reasons for withdrawal
| Measure |
Erlotinib in Combination With Radiotherapy
Erlotinib (150 mg) administered orally once daily starting day 1 and continued with radiotherapy (RT) and through day 365 (one year therapy duration). RT will be administered day 1-28 (Mon-Fri) in dose of 1.8 Gy per fraction.
|
|---|---|
|
Overall Study
Disease progression
|
6
|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
Patient refused
|
2
|
|
Overall Study
Other
|
1
|
|
Overall Study
Death
|
1
|
|
Overall Study
Not treated (became ineligible)
|
4
|
|
Overall Study
Not treated (changed mind)
|
1
|
Baseline Characteristics
Erlotinib and Radiation Therapy in Treating Older Patients With Stage I, Stage II, Stage III, or Stage IV Esophageal Cancer
Baseline characteristics by cohort
| Measure |
Erlotinib in Combination With Radiotherapy
n=17 Participants
Erlotinib (150 mg) administered orally once daily starting day 1 and continued with radiotherapy (RT) and through day 365 (one year therapy duration). RT will be administered day 1-28 (Mon-Fri) in dose of 1.8 Gy per fraction.
|
|---|---|
|
Age, Continuous
|
79.94 years
STANDARD_DEVIATION 6.44 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 yearsOutcome measures
| Measure |
Erlotinib in Combination With Radiotherapy
n=17 Participants
Erlotinib (150 mg) administered orally once daily starting day 1 and continued with radiotherapy (RT) and through day 365 (one year therapy duration). RT will be administered day 1-28 (Mon-Fri) in dose of 1.8 Gy per fraction.
|
Erlotinib in Combination With Radiotherapy at Week 3
Erlotinib (150 mg) administered orally once daily starting day 1 and continued with radiotherapy (RT) and through day 365 (one year therapy duration). RT will be administered day 1-28 (Mon-Fri) in dose of 1.8 Gy per fraction.
|
Never Smokers
|
|---|---|---|---|
|
Overall Survival
|
7.3 months
Interval 3.8 to 22.3
|
—
|
—
|
SECONDARY outcome
Timeframe: 4-8 weeks after completion of radiation.Population: Patients Treated with Study Therapy
Response assessment by CT scans and upper endoscopy performed between 4-8 weeks after completion of radiation. Complete Response (CR) is defined as absence of viable tumor in endoscopic evaluation post chemoradiation, with four-quadrant biopsies taken at 1 cm intervals throughout length of original tumor.
Outcome measures
| Measure |
Erlotinib in Combination With Radiotherapy
n=17 Participants
Erlotinib (150 mg) administered orally once daily starting day 1 and continued with radiotherapy (RT) and through day 365 (one year therapy duration). RT will be administered day 1-28 (Mon-Fri) in dose of 1.8 Gy per fraction.
|
Erlotinib in Combination With Radiotherapy at Week 3
Erlotinib (150 mg) administered orally once daily starting day 1 and continued with radiotherapy (RT) and through day 365 (one year therapy duration). RT will be administered day 1-28 (Mon-Fri) in dose of 1.8 Gy per fraction.
|
Never Smokers
|
|---|---|---|---|
|
Complete Response
|
11.76 percentage of participants
Interval 1.46 to 36.44
|
—
|
—
|
SECONDARY outcome
Timeframe: Every 3 months, up to 5 yearsProgression is defined as at least a 20% increase in the sum of long distance of target lesions taking as reference the smallest sum long distance 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 |
Erlotinib in Combination With Radiotherapy
n=17 Participants
Erlotinib (150 mg) administered orally once daily starting day 1 and continued with radiotherapy (RT) and through day 365 (one year therapy duration). RT will be administered day 1-28 (Mon-Fri) in dose of 1.8 Gy per fraction.
|
Erlotinib in Combination With Radiotherapy at Week 3
Erlotinib (150 mg) administered orally once daily starting day 1 and continued with radiotherapy (RT) and through day 365 (one year therapy duration). RT will be administered day 1-28 (Mon-Fri) in dose of 1.8 Gy per fraction.
|
Never Smokers
|
|---|---|---|---|
|
Progresssion-Free Survival
|
4.5 months
Interval 2.4 to 7.3
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 3Population: Patients Treated with Study Therapy and with FACT-E scores available
Functional Assessment of Cancer Therapy-Esophagus (FACT-E) is a health-related quality of life instrument validated in esophageal cancer patients. All of the scales and single-item measures range in score from 0 to 4. The ranges of average quality of life scores was from 0 to 4 and was adjusted as lower scores indicate better outcomes
Outcome measures
| Measure |
Erlotinib in Combination With Radiotherapy
n=17 Participants
Erlotinib (150 mg) administered orally once daily starting day 1 and continued with radiotherapy (RT) and through day 365 (one year therapy duration). RT will be administered day 1-28 (Mon-Fri) in dose of 1.8 Gy per fraction.
|
Erlotinib in Combination With Radiotherapy at Week 3
n=14 Participants
Erlotinib (150 mg) administered orally once daily starting day 1 and continued with radiotherapy (RT) and through day 365 (one year therapy duration). RT will be administered day 1-28 (Mon-Fri) in dose of 1.8 Gy per fraction.
|
Never Smokers
|
|---|---|---|---|
|
Effect of Study Therapy on Overall Quality of Life as Assessed by FACT-E Scale
|
1.05 FACT-E Score
Interval 0.16 to 2.61
|
1.36 FACT-E Score
Interval 0.51 to 2.26
|
—
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: Patients Treated with Study Therapy
Outcome measures
| Measure |
Erlotinib in Combination With Radiotherapy
n=3 Participants
Erlotinib (150 mg) administered orally once daily starting day 1 and continued with radiotherapy (RT) and through day 365 (one year therapy duration). RT will be administered day 1-28 (Mon-Fri) in dose of 1.8 Gy per fraction.
|
Erlotinib in Combination With Radiotherapy at Week 3
n=12 Participants
Erlotinib (150 mg) administered orally once daily starting day 1 and continued with radiotherapy (RT) and through day 365 (one year therapy duration). RT will be administered day 1-28 (Mon-Fri) in dose of 1.8 Gy per fraction.
|
Never Smokers
n=2 Participants
|
|---|---|---|---|
|
Correlation of Smoking Status With Overall Survival
|
2.4 months
Interval 2.4 to 7.3
|
7.2 months
Interval 3.8 to 42.0
|
16.6 months
Interval 10.9 to 22.3
|
SECONDARY outcome
Timeframe: Radiologic evaluation every 3 months, up to 5 yearsOutcome measures
| Measure |
Erlotinib in Combination With Radiotherapy
n=8 Participants
Erlotinib (150 mg) administered orally once daily starting day 1 and continued with radiotherapy (RT) and through day 365 (one year therapy duration). RT will be administered day 1-28 (Mon-Fri) in dose of 1.8 Gy per fraction.
|
Erlotinib in Combination With Radiotherapy at Week 3
n=8 Participants
Erlotinib (150 mg) administered orally once daily starting day 1 and continued with radiotherapy (RT) and through day 365 (one year therapy duration). RT will be administered day 1-28 (Mon-Fri) in dose of 1.8 Gy per fraction.
|
Never Smokers
|
|---|---|---|---|
|
Response by Epidermal Growth Factor Receptor (EGFR) Expression
Non-responder
|
6 participants
|
5 participants
|
—
|
|
Response by Epidermal Growth Factor Receptor (EGFR) Expression
Responder
|
2 participants
|
3 participants
|
—
|
SECONDARY outcome
Timeframe: Radiologic evaluation every 3 months, up to 5 yearsOutcome measures
| Measure |
Erlotinib in Combination With Radiotherapy
n=8 Participants
Erlotinib (150 mg) administered orally once daily starting day 1 and continued with radiotherapy (RT) and through day 365 (one year therapy duration). RT will be administered day 1-28 (Mon-Fri) in dose of 1.8 Gy per fraction.
|
Erlotinib in Combination With Radiotherapy at Week 3
n=8 Participants
Erlotinib (150 mg) administered orally once daily starting day 1 and continued with radiotherapy (RT) and through day 365 (one year therapy duration). RT will be administered day 1-28 (Mon-Fri) in dose of 1.8 Gy per fraction.
|
Never Smokers
|
|---|---|---|---|
|
Response by Phosphor Epidermal Growth Factor Receptor (pEGFR) Expression
Responder
|
3 participants
|
2 participants
|
—
|
|
Response by Phosphor Epidermal Growth Factor Receptor (pEGFR) Expression
Non-responder
|
5 participants
|
6 participants
|
—
|
SECONDARY outcome
Timeframe: Radiologic evaluation every 3 months, up to 5 yearsOutcome measures
| Measure |
Erlotinib in Combination With Radiotherapy
n=12 Participants
Erlotinib (150 mg) administered orally once daily starting day 1 and continued with radiotherapy (RT) and through day 365 (one year therapy duration). RT will be administered day 1-28 (Mon-Fri) in dose of 1.8 Gy per fraction.
|
Erlotinib in Combination With Radiotherapy at Week 3
n=4 Participants
Erlotinib (150 mg) administered orally once daily starting day 1 and continued with radiotherapy (RT) and through day 365 (one year therapy duration). RT will be administered day 1-28 (Mon-Fri) in dose of 1.8 Gy per fraction.
|
Never Smokers
|
|---|---|---|---|
|
Response by EGFR Mutation Status
Nonresponder
|
9 participants
|
2 participants
|
—
|
|
Response by EGFR Mutation Status
Responder
|
3 participants
|
2 participants
|
—
|
Adverse Events
Erlotinib in Combination With Radiotherapy
Serious events: 9 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Erlotinib in Combination With Radiotherapy
n=17 participants at risk
Erlotinib (150 mg) administered orally once daily starting day 1 and continued with radiotherapy (RT) and through day 365 (one year therapy duration). RT will be administered day 1-28 (Mon-Fri) in dose of 1.8 Gy per fraction.
|
|---|---|
|
Cardiac disorders
Cardiac failure congestive - Grade 5
|
5.9%
1/17 • Number of events 1
|
|
Cardiac disorders
Myocardial infarction - Grade 4
|
5.9%
1/17 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea - Grade 3
|
17.6%
3/17 • Number of events 5
|
|
Gastrointestinal disorders
Ileus - Grade 3
|
11.8%
2/17 • Number of events 2
|
|
Gastrointestinal disorders
Oesophageal stenosis - Grade 2
|
5.9%
1/17 • Number of events 1
|
|
General disorders
Death - Grade 5
|
11.8%
2/17 • Number of events 2
|
|
General disorders
Fatigue - Grade 3
|
5.9%
1/17 • Number of events 1
|
|
General disorders
Non-cardiac chest pain - Grade 3
|
5.9%
1/17 • Number of events 1
|
|
Infections and infestations
Pneumonia - Grade 3
|
5.9%
1/17 • Number of events 1
|
|
Investigations
Haemoglobin - Grade 2
|
5.9%
1/17 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration - Grade 3
|
17.6%
3/17 • Number of events 4
|
|
Metabolism and nutrition disorders
Hyperglycaemia - Grade 2
|
5.9%
1/17 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia - Grade 2
|
5.9%
1/17 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity - Grade 3
|
5.9%
1/17 • Number of events 1
|
|
Nervous system disorders
Nervous system disorder - Grade 4
|
5.9%
1/17 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea - Grade 4
|
5.9%
1/17 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress - Grade 3
|
5.9%
1/17 • Number of events 1
|
Other adverse events
| Measure |
Erlotinib in Combination With Radiotherapy
n=17 participants at risk
Erlotinib (150 mg) administered orally once daily starting day 1 and continued with radiotherapy (RT) and through day 365 (one year therapy duration). RT will be administered day 1-28 (Mon-Fri) in dose of 1.8 Gy per fraction.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia - Grade 1
|
5.9%
1/17 • Number of events 2
|
|
Blood and lymphatic system disorders
Anaemia - Grade 2
|
11.8%
2/17 • Number of events 2
|
|
Blood and lymphatic system disorders
Leukopenia - Grade 1
|
17.6%
3/17 • Number of events 4
|
|
Blood and lymphatic system disorders
Leukopenia - Grade 2
|
5.9%
1/17 • Number of events 1
|
|
Blood and lymphatic system disorders
Lymphopenia - Grade 1
|
41.2%
7/17 • Number of events 10
|
|
Blood and lymphatic system disorders
Lymphopenia - Grade 2
|
64.7%
11/17 • Number of events 17
|
|
Blood and lymphatic system disorders
Lymphopenia - Grade 3
|
47.1%
8/17 • Number of events 10
|
|
Blood and lymphatic system disorders
Lymphopenia - Grade 4
|
11.8%
2/17 • Number of events 2
|
|
Blood and lymphatic system disorders
Neutropenia - Grade 1
|
5.9%
1/17 • Number of events 2
|
|
Blood and lymphatic system disorders
Neutropenia - Grade 2
|
5.9%
1/17 • Number of events 1
|
|
Blood and lymphatic system disorders
Thrombocytopenia - Grade 1
|
11.8%
2/17 • Number of events 2
|
|
Cardiac disorders
Acute myocardial infarction - Grade 4
|
5.9%
1/17 • Number of events 1
|
|
Cardiac disorders
Angina pectoris - Grade 1
|
5.9%
1/17 • Number of events 1
|
|
Cardiac disorders
Angina pectoris - Grade 2
|
5.9%
1/17 • Number of events 2
|
|
Cardiac disorders
Ventricular arrhythmia - Grade 4
|
5.9%
1/17 • Number of events 1
|
|
Eye disorders
Vision blurred - Grade 3
|
5.9%
1/17 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal distension - Grade 1
|
5.9%
1/17 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain - Grade 1
|
17.6%
3/17 • Number of events 3
|
|
Gastrointestinal disorders
Chapped lips - Grade 1
|
5.9%
1/17 • Number of events 1
|
|
Gastrointestinal disorders
Constipation - Grade 1
|
11.8%
2/17 • Number of events 2
|
|
Gastrointestinal disorders
Constipation - Grade 2
|
5.9%
1/17 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhoea - Grade 1
|
47.1%
8/17 • Number of events 16
|
|
Gastrointestinal disorders
Diarrhoea - Grade 2
|
17.6%
3/17 • Number of events 3
|
|
Gastrointestinal disorders
Dyspepsia - Grade 1
|
5.9%
1/17 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia - Grade 2
|
5.9%
1/17 • Number of events 1
|
|
Gastrointestinal disorders
Dysphagia - Grade 1
|
11.8%
2/17 • Number of events 2
|
|
Gastrointestinal disorders
Dysphagia - Grade 2
|
29.4%
5/17 • Number of events 5
|
|
Gastrointestinal disorders
Dysphagia - Grade 3
|
11.8%
2/17 • Number of events 2
|
|
Gastrointestinal disorders
Eructation - Grade 1
|
5.9%
1/17 • Number of events 1
|
|
Gastrointestinal disorders
Flatulence - Grade 1
|
5.9%
1/17 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis - Grade 1
|
5.9%
1/17 • Number of events 1
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease - Grade 1
|
5.9%
1/17 • Number of events 1
|
|
Gastrointestinal disorders
Impaired gastric emptying - Grade 2
|
5.9%
1/17 • Number of events 1
|
|
Gastrointestinal disorders
Nausea - Grade 1
|
35.3%
6/17 • Number of events 10
|
|
Gastrointestinal disorders
Nausea - Grade 2
|
5.9%
1/17 • Number of events 1
|
|
Gastrointestinal disorders
Nausea - Grade 3
|
5.9%
1/17 • Number of events 1
|
|
Gastrointestinal disorders
Odynophagia - Grade 1
|
5.9%
1/17 • Number of events 1
|
|
Gastrointestinal disorders
Odynophagia - Grade 2
|
5.9%
1/17 • Number of events 1
|
|
Gastrointestinal disorders
Oesophageal obstruction - Grade 3
|
5.9%
1/17 • Number of events 1
|
|
Gastrointestinal disorders
Oesophageal stenosis - Grade 2
|
11.8%
2/17 • Number of events 2
|
|
Gastrointestinal disorders
Oesophageal stenosis - Grade 3
|
5.9%
1/17 • Number of events 1
|
|
Gastrointestinal disorders
Oesophagitis - Grade 1
|
5.9%
1/17 • Number of events 1
|
|
Gastrointestinal disorders
Oesophagitis - Grade 2
|
11.8%
2/17 • Number of events 2
|
|
Gastrointestinal disorders
Reflux oesophagitis - Grade 1
|
5.9%
1/17 • Number of events 1
|
|
Gastrointestinal disorders
Reflux oesophagitis - Grade 2
|
11.8%
2/17 • Number of events 2
|
|
Gastrointestinal disorders
Retching - Grade 1
|
5.9%
1/17 • Number of events 1
|
|
Gastrointestinal disorders
Stomatitis - Grade 1
|
11.8%
2/17 • Number of events 2
|
|
Gastrointestinal disorders
Stomatitis - Grade 2
|
11.8%
2/17 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting - Grade 1
|
23.5%
4/17 • Number of events 8
|
|
Gastrointestinal disorders
Vomiting - Grade 2
|
17.6%
3/17 • Number of events 3
|
|
General disorders
Chills - Grade 1
|
5.9%
1/17 • Number of events 1
|
|
General disorders
Early satiety - Grade 2
|
5.9%
1/17 • Number of events 1
|
|
General disorders
Fatigue - Grade 1
|
64.7%
11/17 • Number of events 14
|
|
General disorders
Fatigue - Grade 2
|
70.6%
12/17 • Number of events 12
|
|
General disorders
Fatigue - Grade 3
|
5.9%
1/17 • Number of events 1
|
|
General disorders
Mucosal inflammation - Grade 1
|
23.5%
4/17 • Number of events 6
|
|
General disorders
Oedema - Grade 1
|
5.9%
1/17 • Number of events 1
|
|
General disorders
Oedema peripheral - Grade 1
|
17.6%
3/17 • Number of events 3
|
|
General disorders
Oedema peripheral - Grade 2
|
5.9%
1/17 • Number of events 1
|
|
General disorders
Pain - Grade 2
|
17.6%
3/17 • Number of events 3
|
|
Hepatobiliary disorders
Hyperbilirubinaemia - Grade 1
|
11.8%
2/17 • Number of events 4
|
|
Hepatobiliary disorders
Hyperbilirubinaemia - Grade 2
|
5.9%
1/17 • Number of events 1
|
|
Infections and infestations
Fungal skin infection - Grade 1
|
5.9%
1/17 • Number of events 1
|
|
Infections and infestations
Fungal skin infection - Grade 2
|
5.9%
1/17 • Number of events 2
|
|
Infections and infestations
Infection - Grade 2
|
5.9%
1/17 • Number of events 2
|
|
Infections and infestations
Urinary tract infection - Grade 2
|
11.8%
2/17 • Number of events 2
|
|
Injury, poisoning and procedural complications
Contusion - Grade 1
|
5.9%
1/17 • Number of events 1
|
|
Injury, poisoning and procedural complications
Facial bones fracture - Grade 2
|
5.9%
1/17 • Number of events 1
|
|
Injury, poisoning and procedural complications
Procedural site reaction - Grade 2
|
5.9%
1/17 • Number of events 1
|
|
Injury, poisoning and procedural complications
Rib fracture - Grade 2
|
5.9%
1/17 • Number of events 1
|
|
Injury, poisoning and procedural complications
Skin laceration - Grade 2
|
5.9%
1/17 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased - Grade 1
|
17.6%
3/17 • Number of events 3
|
|
Investigations
Aspartate aminotransferase - Grade 1
|
11.8%
2/17 • Number of events 2
|
|
Investigations
Aspartate aminotransferase increased - Grade 1
|
29.4%
5/17 • Number of events 7
|
|
Investigations
Aspartate aminotransferase increased - Grade 2
|
5.9%
1/17 • Number of events 1
|
|
Investigations
Blood alkaline phosphatase - Grade 1
|
11.8%
2/17 • Number of events 3
|
|
Investigations
Blood alkaline phosphatase - Grade 2
|
5.9%
1/17 • Number of events 1
|
|
Investigations
Blood alkaline phosphatase increased - Grade 1
|
5.9%
1/17 • Number of events 1
|
|
Investigations
Blood bilirubin - Grade 1
|
11.8%
2/17 • Number of events 2
|
|
Investigations
Blood bilirubin - Grade 2
|
11.8%
2/17 • Number of events 2
|
|
Investigations
Blood bilirubin increased - Grade 1
|
5.9%
1/17 • Number of events 1
|
|
Investigations
Blood bilirubin increased - Grade 2
|
5.9%
1/17 • Number of events 2
|
|
Investigations
Blood calcium decreased - Grade 1
|
5.9%
1/17 • Number of events 1
|
|
Investigations
Blood creatine - Grade 2
|
5.9%
1/17 • Number of events 1
|
|
Investigations
Blood creatine increased - Grade 1
|
5.9%
1/17 • Number of events 1
|
|
Investigations
Blood creatinine - Grade 1
|
17.6%
3/17 • Number of events 3
|
|
Investigations
Blood creatinine - Grade 2
|
5.9%
1/17 • Number of events 5
|
|
Investigations
Haemoglobin - Grade 1
|
35.3%
6/17 • Number of events 7
|
|
Investigations
International normalised ratio increased - Grade 1
|
5.9%
1/17 • Number of events 1
|
|
Investigations
International normalised ratio increased - Grade 2
|
5.9%
1/17 • Number of events 1
|
|
Investigations
International normalised ratio increased - Grade 3
|
5.9%
1/17 • Number of events 2
|
|
Investigations
Platelet count decreased - Grade 1
|
23.5%
4/17 • Number of events 6
|
|
Investigations
Troponin I increased - Grade 4
|
5.9%
1/17 • Number of events 1
|
|
Investigations
Weight decreased - Grade 1
|
58.8%
10/17 • Number of events 11
|
|
Investigations
Weight decreased - Grade 2
|
29.4%
5/17 • Number of events 5
|
|
Metabolism and nutrition disorders
Anorexia - Grade 1
|
23.5%
4/17 • Number of events 6
|
|
Metabolism and nutrition disorders
Anorexia - Grade 2
|
29.4%
5/17 • Number of events 6
|
|
Metabolism and nutrition disorders
Anorexia - Grade 3
|
5.9%
1/17 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration - Grade 1
|
5.9%
1/17 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration - Grade 2
|
29.4%
5/17 • Number of events 6
|
|
Metabolism and nutrition disorders
Gout - Grade 2
|
5.9%
1/17 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypercalcaemia - Grade 1
|
5.9%
1/17 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyperglycaemia - Grade 1
|
23.5%
4/17 • Number of events 7
|
|
Metabolism and nutrition disorders
Hyperglycaemia - Grade 2
|
23.5%
4/17 • Number of events 5
|
|
Metabolism and nutrition disorders
Hyperkalaemia - Grade 1
|
17.6%
3/17 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypernatraemia - Grade 1
|
5.9%
1/17 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia - Grade 1
|
29.4%
5/17 • Number of events 5
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia - Grade 2
|
23.5%
4/17 • Number of events 6
|
|
Metabolism and nutrition disorders
Hypocalcaemia - Grade 1
|
11.8%
2/17 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypocalcaemia - Grade 2
|
5.9%
1/17 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoglycaemia - Grade 1
|
5.9%
1/17 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypokalaemia - Grade 1
|
11.8%
2/17 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypomagnesaemia - Grade 1
|
5.9%
1/17 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyponatraemia - Grade 1
|
35.3%
6/17 • Number of events 8
|
|
Metabolism and nutrition disorders
Hyponatraemia - Grade 3
|
5.9%
1/17 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia - Grade 1
|
5.9%
1/17 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Back pain - Grade 1
|
17.6%
3/17 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Buttock pain - Grade 1
|
5.9%
1/17 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis - Grade 1
|
5.9%
1/17 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Groin pain - Grade 1
|
11.8%
2/17 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Groin pain - Grade 2
|
5.9%
1/17 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms - Grade 1
|
5.9%
1/17 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain - Grade 1
|
5.9%
1/17 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain - Grade 2
|
5.9%
1/17 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain - Grade 2
|
11.8%
2/17 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity - Grade 1
|
5.9%
1/17 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity - Grade 2
|
11.8%
2/17 • Number of events 2
|
|
Nervous system disorders
Dizziness - Grade 1
|
5.9%
1/17 • Number of events 3
|
|
Nervous system disorders
Dizziness - Grade 2
|
5.9%
1/17 • Number of events 1
|
|
Nervous system disorders
Dysgeusia - Grade 1
|
23.5%
4/17 • Number of events 5
|
|
Nervous system disorders
Headache - Grade 1
|
5.9%
1/17 • Number of events 1
|
|
Nervous system disorders
Syncope - Grade 3
|
11.8%
2/17 • Number of events 2
|
|
Nervous system disorders
Tremor - Grade 1
|
5.9%
1/17 • Number of events 1
|
|
Psychiatric disorders
Depression - Grade 1
|
5.9%
1/17 • Number of events 1
|
|
Psychiatric disorders
Depression - Grade 2
|
11.8%
2/17 • Number of events 2
|
|
Psychiatric disorders
Insomnia - Grade 1
|
5.9%
1/17 • Number of events 1
|
|
Psychiatric disorders
Insomnia - Grade 2
|
11.8%
2/17 • Number of events 2
|
|
Renal and urinary disorders
Pollakiuria - Grade 2
|
5.9%
1/17 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough - Grade 1
|
23.5%
4/17 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia - Grade 1
|
11.8%
2/17 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia - Grade 2
|
5.9%
1/17 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea - Grade 1
|
11.8%
2/17 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea - Grade 3
|
11.8%
2/17 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis - Grade 1
|
5.9%
1/17 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis - Grade 2
|
5.9%
1/17 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups - Grade 1
|
5.9%
1/17 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer - Grade 2
|
5.9%
1/17 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform - Grade 1
|
5.9%
1/17 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform - Grade 2
|
5.9%
1/17 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Drug eruption - Grade 1
|
17.6%
3/17 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Drug eruption - Grade 2
|
17.6%
3/17 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis - Grade 2
|
5.9%
1/17 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome - Grade 1
|
11.8%
2/17 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome - Grade 2
|
11.8%
2/17 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Pruritus - Grade 1
|
5.9%
1/17 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus - Grade 2
|
5.9%
1/17 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash - Grade 1
|
35.3%
6/17 • Number of events 14
|
|
Skin and subcutaneous tissue disorders
Rash - Grade 2
|
41.2%
7/17 • Number of events 8
|
|
Skin and subcutaneous tissue disorders
Rash pruritic - Grade 2
|
5.9%
1/17 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin disorder - Grade 2
|
5.9%
1/17 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation - Grade 1
|
5.9%
1/17 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin ulcer - Grade 1
|
5.9%
1/17 • Number of events 1
|
|
Vascular disorders
Deep vein thrombosis - Grade 3
|
5.9%
1/17 • Number of events 1
|
|
Vascular disorders
Hypotension - Grade 2
|
5.9%
1/17 • Number of events 1
|
|
Vascular disorders
Hypotension - Grade 4
|
5.9%
1/17 • Number of events 1
|
|
Vascular disorders
Orthostatic hypotension - Grade 1
|
5.9%
1/17 • Number of events 2
|
|
Vascular disorders
Orthostatic hypotension - Grade 2
|
5.9%
1/17 • 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