Trial Outcomes & Findings for Everolimus and Combination Chemotherapy in Treating Patients With Metastatic Stomach or Esophageal Cancer (NCT NCT01231399)
NCT ID: NCT01231399
Last Updated: 2017-05-31
Results Overview
The highest dose tested in which fewer than 33% of patients experience an attributable DLT to the study drug, when at least 6 patients are treated at that dose and are evaluable for toxicity. Toxicities will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
6 participants
Primary outcome timeframe
Course 1 (first 28 days)
Results posted on
2017-05-31
Participant Flow
Participant milestones
| Measure |
Dose Level 1 - 2.5 mg Everolimus Daily
Patients receive 400 mg/m\^2 fluorouracil (5-FU) IV slow push day 1, 2,400 mg/m\^2 fluorouracil (5-FU) IV continuously over 46 hours days 1-2, 400 mg/m\^2 leucovorin calcium IV over 2 hours, and 85 mg/m\^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 2.5 mg oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
fluorouracil: Given IV
leucovorin calcium: Given IV
oxaliplatin: Given IV
everolimus: Given orally
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Everolimus and Combination Chemotherapy in Treating Patients With Metastatic Stomach or Esophageal Cancer
Baseline characteristics by cohort
| Measure |
Dose Level 1 - 2.5 mg Everolimus Daily
n=6 Participants
Patients receive 400 mg/m\^2 fluorouracil (5-FU) IV slow push day 1, 2,400 mg/m\^2 fluorouracil (5-FU) IV continuously over 46 hours days 1-2, 400 mg/m\^2 leucovorin calcium IV over 2 hours, and 85 mg/m\^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 2.5 mg oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
fluorouracil: Given IV
leucovorin calcium: Given IV
oxaliplatin: Given IV
everolimus: Given orally
|
|---|---|
|
Age, Continuous
|
58 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Course 1 (first 28 days)Population: All patients observed for 28 days while receiving a full course of therapy or who experienced a DLT. Patients withdrawing before completion of the first course, for reasons other than DLT, were replaced.
The highest dose tested in which fewer than 33% of patients experience an attributable DLT to the study drug, when at least 6 patients are treated at that dose and are evaluable for toxicity. Toxicities will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
Outcome measures
| Measure |
Dose Level 1 - 2.5 mg Everolimus
n=6 Participants
Patients receive 400 mg/m\^2 fluorouracil (5-FU) IV slow push day 1, 2,400 mg/m\^2 fluorouracil (5-FU) IV continuously over 46 hours days 1-2, 400 mg/m\^2 leucovorin calcium IV over 2 hours, and 85 mg/m\^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 2.5 mg oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
fluorouracil: Given IV
leucovorin calcium: Given IV
oxaliplatin: Given IV
everolimus: Given orally
|
|---|---|
|
Maximum Tolerated Dose (MTD) of Everolimus
|
2.5 mg
|
PRIMARY outcome
Timeframe: Up to 5 yearsPer 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 |
Dose Level 1 - 2.5 mg Everolimus
n=6 Participants
Patients receive 400 mg/m\^2 fluorouracil (5-FU) IV slow push day 1, 2,400 mg/m\^2 fluorouracil (5-FU) IV continuously over 46 hours days 1-2, 400 mg/m\^2 leucovorin calcium IV over 2 hours, and 85 mg/m\^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 2.5 mg oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
fluorouracil: Given IV
leucovorin calcium: Given IV
oxaliplatin: Given IV
everolimus: Given orally
|
|---|---|
|
Number of Subject With Overall Response
|
5 participants
|
PRIMARY outcome
Timeframe: up to 5 yearsEstimated using the product-limit method of Kaplan and Meier. From the date treatment started until the date of first documented progression or date of death from any cause, whichever came first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Dose Level 1 - 2.5 mg Everolimus
n=6 Participants
Patients receive 400 mg/m\^2 fluorouracil (5-FU) IV slow push day 1, 2,400 mg/m\^2 fluorouracil (5-FU) IV continuously over 46 hours days 1-2, 400 mg/m\^2 leucovorin calcium IV over 2 hours, and 85 mg/m\^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 2.5 mg oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
fluorouracil: Given IV
leucovorin calcium: Given IV
oxaliplatin: Given IV
everolimus: Given orally
|
|---|---|
|
Progression-free Survival
|
14.5 Months
Interval 2.0 to 21.0
|
PRIMARY outcome
Timeframe: Up to 5 years.Estimated using the product-limit method of Kaplan and Meier. From the date treatment started until the date of death from any cause.
Outcome measures
| Measure |
Dose Level 1 - 2.5 mg Everolimus
n=6 Participants
Patients receive 400 mg/m\^2 fluorouracil (5-FU) IV slow push day 1, 2,400 mg/m\^2 fluorouracil (5-FU) IV continuously over 46 hours days 1-2, 400 mg/m\^2 leucovorin calcium IV over 2 hours, and 85 mg/m\^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 2.5 mg oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
fluorouracil: Given IV
leucovorin calcium: Given IV
oxaliplatin: Given IV
everolimus: Given orally
|
|---|---|
|
Overall Survival
|
20.3 Months
Interval 15.6 to 28.9
|
Adverse Events
Dose Level 1 - 2.5 mg Everolimus Daily
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dose Level 1 - 2.5 mg Everolimus Daily
n=6 participants at risk
Patients receive 400 mg/m\^2 fluorouracil (5-FU) IV slow push day 1, 2,400 mg/m\^2 fluorouracil (5-FU) IV continuously over 46 hours days 1-2, 400 mg/m\^2 leucovorin calcium IV over 2 hours, and 85 mg/m\^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 2.5 mg oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
fluorouracil: Given IV
leucovorin calcium: Given IV
oxaliplatin: Given IV
everolimus: Given orally
|
|---|---|
|
Gastrointestinal disorders
Mucositis oral
|
16.7%
1/6 • Number of events 2 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Chills
|
16.7%
1/6 • Number of events 1 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Fever
|
16.7%
1/6 • Number of events 1 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Flu like symptoms
|
16.7%
1/6 • Number of events 1 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Catheter related infection
|
16.7%
1/6 • Number of events 1 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
Other adverse events
| Measure |
Dose Level 1 - 2.5 mg Everolimus Daily
n=6 participants at risk
Patients receive 400 mg/m\^2 fluorouracil (5-FU) IV slow push day 1, 2,400 mg/m\^2 fluorouracil (5-FU) IV continuously over 46 hours days 1-2, 400 mg/m\^2 leucovorin calcium IV over 2 hours, and 85 mg/m\^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 2.5 mg oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
fluorouracil: Given IV
leucovorin calcium: Given IV
oxaliplatin: Given IV
everolimus: Given orally
|
|---|---|
|
Investigations
Hyperglycemia
|
66.7%
4/6 • Number of events 8 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Hypocalcemia
|
50.0%
3/6 • Number of events 15 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
6/6 • Number of events 66 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Sinus bradycardia
|
33.3%
2/6 • Number of events 5 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Sinus tachycardia
|
50.0%
3/6 • Number of events 8 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Eye disorders
Watering eyes
|
16.7%
1/6 • Number of events 1 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
50.0%
3/6 • Number of events 25 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Bloating
|
16.7%
1/6 • Number of events 1 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Constipation
|
66.7%
4/6 • Number of events 21 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
3/6 • Number of events 6 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
33.3%
2/6 • Number of events 3 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
50.0%
3/6 • Number of events 6 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
33.3%
2/6 • Number of events 5 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Esophageal pain
|
16.7%
1/6 • Number of events 1 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Flatulence
|
16.7%
1/6 • Number of events 1 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
33.3%
2/6 • Number of events 9 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, spec
|
33.3%
2/6 • Number of events 3 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Hemorrhoids
|
16.7%
1/6 • Number of events 3 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Mucositis oral
|
66.7%
4/6 • Number of events 14 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Nausea
|
100.0%
6/6 • Number of events 34 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Oral pain
|
16.7%
1/6 • Number of events 1 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
16.7%
1/6 • Number of events 2 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
3/6 • Number of events 5 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Chills
|
16.7%
1/6 • Number of events 2 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Edema face
|
16.7%
1/6 • Number of events 1 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Fatigue
|
100.0%
6/6 • Number of events 56 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Fever
|
33.3%
2/6 • Number of events 4 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Flu like symptoms
|
16.7%
1/6 • Number of events 1 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Gait disturbance
|
16.7%
1/6 • Number of events 1 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Infusion related reaction
|
16.7%
1/6 • Number of events 1 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Injection site reaction
|
33.3%
2/6 • Number of events 3 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Pain
|
33.3%
2/6 • Number of events 4 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Mucosal infection
|
16.7%
1/6 • Number of events 1 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Skin infection
|
16.7%
1/6 • Number of events 3 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Upper respiratory infection
|
16.7%
1/6 • Number of events 1 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Urinary tract infection
|
16.7%
1/6 • Number of events 1 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Wound infection
|
16.7%
1/6 • Number of events 2 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
33.3%
2/6 • Number of events 2 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Activated partial thromboplastin time pr
|
33.3%
2/6 • Number of events 10 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Alanine aminotransferase increased
|
83.3%
5/6 • Number of events 31 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Alkaline phosphatase increased
|
83.3%
5/6 • Number of events 35 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
83.3%
5/6 • Number of events 37 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
CPK increased
|
16.7%
1/6 • Number of events 2 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Cholesterol high
|
83.3%
5/6 • Number of events 32 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Creatinine increased
|
16.7%
1/6 • Number of events 2 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Haptoglobin decreased
|
16.7%
1/6 • Number of events 1 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
INR increased
|
16.7%
1/6 • Number of events 8 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Lymphocyte count decreased
|
50.0%
3/6 • Number of events 8 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Lymphocyte count increased
|
16.7%
1/6 • Number of events 1 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Neutrophil count decreased
|
100.0%
6/6 • Number of events 29 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Platelet count decreased
|
83.3%
5/6 • Number of events 30 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Weight gain
|
33.3%
2/6 • Number of events 3 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Weight loss
|
50.0%
3/6 • Number of events 17 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
White blood cell decreased
|
100.0%
6/6 • Number of events 28 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
66.7%
4/6 • Number of events 17 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
16.7%
1/6 • Number of events 1 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
16.7%
1/6 • Number of events 2 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
66.7%
4/6 • Number of events 37 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
16.7%
1/6 • Number of events 3 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
66.7%
4/6 • Number of events 11 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
33.3%
2/6 • Number of events 2 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
50.0%
3/6 • Number of events 19 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Obesity
|
50.0%
3/6 • Number of events 17 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
50.0%
3/6 • Number of events 4 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
50.0%
3/6 • Number of events 20 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
50.0%
3/6 • Number of events 3 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
16.7%
1/6 • Number of events 1 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
16.7%
1/6 • Number of events 1 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness trunk
|
16.7%
1/6 • Number of events 1 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue di
|
16.7%
1/6 • Number of events 1 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.7%
1/6 • Number of events 1 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
16.7%
1/6 • Number of events 1 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.7%
1/6 • Number of events 1 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
16.7%
1/6 • Number of events 5 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Akathisia
|
16.7%
1/6 • Number of events 1 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Ataxia
|
16.7%
1/6 • Number of events 2 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Cognitive disturbance
|
16.7%
1/6 • Number of events 1 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Dysarthria
|
33.3%
2/6 • Number of events 2 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Dysgeusia
|
50.0%
3/6 • Number of events 10 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Dysphasia
|
16.7%
1/6 • Number of events 1 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Headache
|
33.3%
2/6 • Number of events 2 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Memory impairment
|
16.7%
1/6 • Number of events 2 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Paresthesia
|
66.7%
4/6 • Number of events 12 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
33.3%
2/6 • Number of events 6 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
83.3%
5/6 • Number of events 30 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Somnolence
|
16.7%
1/6 • Number of events 1 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Tremor
|
16.7%
1/6 • Number of events 13 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Agitation
|
16.7%
1/6 • Number of events 1 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Anxiety
|
33.3%
2/6 • Number of events 11 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Confusion
|
33.3%
2/6 • Number of events 3 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Depression
|
50.0%
3/6 • Number of events 20 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Insomnia
|
33.3%
2/6 • Number of events 23 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Restlessness
|
16.7%
1/6 • Number of events 1 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Suicidal ideation
|
16.7%
1/6 • Number of events 1 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Hematuria
|
50.0%
3/6 • Number of events 11 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Proteinuria
|
50.0%
3/6 • Number of events 9 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Urinary frequency
|
16.7%
1/6 • Number of events 1 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Urinary tract pain
|
16.7%
1/6 • Number of events 1 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
16.7%
1/6 • Number of events 4 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
3/6 • Number of events 3 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
16.7%
1/6 • Number of events 1 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal di
|
33.3%
2/6 • Number of events 3 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
33.3%
2/6 • Number of events 2 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
16.7%
1/6 • Number of events 1 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
16.7%
1/6 • Number of events 1 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
50.0%
3/6 • Number of events 9 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders -
|
16.7%
1/6 • Number of events 1 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Hypertension
|
100.0%
6/6 • Number of events 74 • Adverse events occurred over a period of 2 years, 6 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place