Trial Outcomes & Findings for Calcium Gluconate and Magnesium Sulfate in Preventing Neurotoxicity Caused By Oxaliplatin in Patients Receiving Combination Chemotherapy for Stage II, Stage III, or Stage IV Colorectal Cancer That Has Been Completely Removed By Surgery (NCT NCT00316914)
NCT ID: NCT00316914
Last Updated: 2016-08-11
Results Overview
Neuropathic adverse events were assessed by Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Neurotoxicity evaluation grade: loss of deep tendon reflexes or paresthesia, including tingling, but not interfering with function (Grade 1); objective sensory alteration or paresthesia, including tingling, interfering with function, but not with activities of daily living (Grade 2); sensory alteration or paresthesia interfering with activities of daily living (Grade 3); permanent sensory losses that are disabling (Grade 4)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
104 participants
Primary outcome timeframe
127 days
Results posted on
2016-08-11
Participant Flow
One-hundred and four (104) participants were recruited between January 2006 and June 2007 from 20 North Central Cancer Treatment Group (NCCTG) member sites.
Two participants in Calcium/Magnesium arm canceled prior to study medication begins. These two participants were excluded from all analysis.
Participant milestones
| Measure |
Ca/Mg
Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
|
Placebo
Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
52
|
|
Overall Study
COMPLETED
|
17
|
16
|
|
Overall Study
NOT COMPLETED
|
33
|
36
|
Reasons for withdrawal
| Measure |
Ca/Mg
Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
|
Placebo
Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
3
|
|
Overall Study
Adverse Event
|
8
|
7
|
|
Overall Study
Other Problems
|
6
|
11
|
|
Overall Study
Missing end of treatment documentation
|
14
|
15
|
Baseline Characteristics
Calcium Gluconate and Magnesium Sulfate in Preventing Neurotoxicity Caused By Oxaliplatin in Patients Receiving Combination Chemotherapy for Stage II, Stage III, or Stage IV Colorectal Cancer That Has Been Completely Removed By Surgery
Baseline characteristics by cohort
| Measure |
Ca/Mg
n=50 Participants
Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
|
Placebo
n=52 Participants
Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
|
Total
n=102 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<65
|
33 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Age, Customized
>=65
|
17 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
48 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=5 Participants
|
52 participants
n=7 Participants
|
102 participants
n=5 Participants
|
|
Regimen
FOLFOX4 (Oxaliplatin, Leucovorin, and Fluorouracil
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Regimen
Modified FOLFOX6
|
47 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 127 daysPopulation: Efficacy analyses use all patients that reported at least one value after baseline.
Neuropathic adverse events were assessed by Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Neurotoxicity evaluation grade: loss of deep tendon reflexes or paresthesia, including tingling, but not interfering with function (Grade 1); objective sensory alteration or paresthesia, including tingling, interfering with function, but not with activities of daily living (Grade 2); sensory alteration or paresthesia interfering with activities of daily living (Grade 3); permanent sensory losses that are disabling (Grade 4)
Outcome measures
| Measure |
Ca/Mg
n=50 Participants
Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
|
Placebo
n=52 Participants
Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
|
|---|---|---|
|
Percentage of Patients With Oxaliplatin-induced Grade 2+ Chronic Neuropathic Adverse Event
|
22 Percentage of participants
|
41 Percentage of participants
|
SECONDARY outcome
Timeframe: 127 daysPopulation: Includes all patients that reported at least one value after baseline.
Neurotoxicity were assessed by Common Terminology Criteria for Adverse Events (CTCAE) v3.0.
Outcome measures
| Measure |
Ca/Mg
n=50 Participants
Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
|
Placebo
n=52 Participants
Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
|
|---|---|---|
|
Time to Onset of Grade 2+ Chronic Neurotoxicity
|
NA Days
The median and 95% confidence interval was not calculable because insufficient number of participants reached the event at the final time point for assessment.
|
18.1 Days
Interval 15.0 to
The upper limit of the 95% confidence interval was infinity.
|
SECONDARY outcome
Timeframe: 127 daysPopulation: Includes all patients that reported at least one value after baseline.
Neurotoxicity was assessed by CTCAE v3.0.
Outcome measures
| Measure |
Ca/Mg
n=50 Participants
Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
|
Placebo
n=52 Participants
Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
|
|---|---|---|
|
Time to Onset of Grade 3+ Chronic Neurotoxicity
|
NA Days
The median and 95% confidence interval was not calculable because insufficient number of participants reached the event at the final time point for assessment.
|
NA Days
The median and 95% confidence interval was not calculable because insufficient number of participants reached the event at the final time point for assessment.
|
SECONDARY outcome
Timeframe: 127 daysPopulation: Includes all patients that reported at least one value after baseline.
Neuropathic adverse events were assessed by CTCAE v3.0.
Outcome measures
| Measure |
Ca/Mg
n=50 Participants
Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
|
Placebo
n=52 Participants
Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
|
|---|---|---|
|
Average Duration of Chronic Neuropathic Toxicity
|
81 days
Interval 52.0 to 92.0
|
72 days
Interval 43.0 to 85.0
|
SECONDARY outcome
Timeframe: 127 daysPopulation: Includes all patients that reported at least one value after baseline.
Neurotoxicity were assessed by CTCAE v3.0.
Outcome measures
| Measure |
Ca/Mg
n=50 Participants
Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
|
Placebo
n=52 Participants
Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
|
|---|---|---|
|
Percentage of Patients Discontinuing Therapy for Chronic Neurotoxicity
|
46 Percentage of Participants
|
55.8 Percentage of Participants
|
SECONDARY outcome
Timeframe: 127 daysPopulation: Because of the early closure of this trial, no reliable data were available for this outcome.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 127 daysPopulation: Because of the early closure of this trial, no reliable data were available for this outcome.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 127 daysPopulation: Includes all patients that reported at least one value after baseline.
Acute neuropathic toxicities were measured using the Symptom Experience Diary and supplemental quality of life questions in the scale of 0 (no symptom) to 10 (worst symptom). The item score was reversed and transformed into 0 (low QOL) to 100 (best QOL) scale for analysis. Any score greater than 0 was considered having acute neuropathy.
Outcome measures
| Measure |
Ca/Mg
n=50 Participants
Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
|
Placebo
n=52 Participants
Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
|
|---|---|---|
|
Percentage of Patients With Acute Neuropathic Adverse Event
|
88 Percentage of participants
|
90 Percentage of participants
|
SECONDARY outcome
Timeframe: 127 daysPopulation: Analyses of adverse events includes all patients. Adverse event data is not available on one patient in Placebo arm, which leads to the total of 51 in Placebo arm for analysis.
Adverse Events were measured using CTCAE V3.0.
Outcome measures
| Measure |
Ca/Mg
n=50 Participants
Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
|
Placebo
n=51 Participants
Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
|
|---|---|---|
|
Incidence of Calcium Magnesium (CaMg)-Induced Adverse Event
Urticaria
|
0 Percentage of Participants
|
2 Percentage of Participants
|
|
Incidence of Calcium Magnesium (CaMg)-Induced Adverse Event
Vasc Access Complication
|
2 Percentage of Participants
|
0 Percentage of Participants
|
|
Incidence of Calcium Magnesium (CaMg)-Induced Adverse Event
Abdominal Infection
|
2 Percentage of Participants
|
0 Percentage of Participants
|
|
Incidence of Calcium Magnesium (CaMg)-Induced Adverse Event
Acne NOS
|
2 Percentage of Participants
|
2 Percentage of Participants
|
|
Incidence of Calcium Magnesium (CaMg)-Induced Adverse Event
Anemia
|
4 Percentage of Participants
|
4 Percentage of Participants
|
|
Incidence of Calcium Magnesium (CaMg)-Induced Adverse Event
Anorexia
|
4 Percentage of Participants
|
2 Percentage of Participants
|
|
Incidence of Calcium Magnesium (CaMg)-Induced Adverse Event
Clostridial Infection
|
0 Percentage of Participants
|
2 Percentage of Participants
|
|
Incidence of Calcium Magnesium (CaMg)-Induced Adverse Event
Constipation
|
42 Percentage of Participants
|
47 Percentage of Participants
|
|
Incidence of Calcium Magnesium (CaMg)-Induced Adverse Event
Dehydration
|
2 Percentage of Participants
|
6 Percentage of Participants
|
|
Incidence of Calcium Magnesium (CaMg)-Induced Adverse Event
Diarrhea-No Colostom
|
68 Percentage of Participants
|
73 Percentage of Participants
|
|
Incidence of Calcium Magnesium (CaMg)-Induced Adverse Event
Dry Skin
|
0 Percentage of Participants
|
2 Percentage of Participants
|
|
Incidence of Calcium Magnesium (CaMg)-Induced Adverse Event
Erythema Multiforme
|
4 Percentage of Participants
|
0 Percentage of Participants
|
|
Incidence of Calcium Magnesium (CaMg)-Induced Adverse Event
Fatigue
|
10 Percentage of Participants
|
25 Percentage of Participants
|
|
Incidence of Calcium Magnesium (CaMg)-Induced Adverse Event
Hypercalcemia
|
0 Percentage of Participants
|
2 Percentage of Participants
|
|
Incidence of Calcium Magnesium (CaMg)-Induced Adverse Event
Hyperglycemia
|
2 Percentage of Participants
|
0 Percentage of Participants
|
|
Incidence of Calcium Magnesium (CaMg)-Induced Adverse Event
Hypermagnesemia
|
14 Percentage of Participants
|
18 Percentage of Participants
|
|
Incidence of Calcium Magnesium (CaMg)-Induced Adverse Event
Hypersensitivity
|
6 Percentage of Participants
|
0 Percentage of Participants
|
|
Incidence of Calcium Magnesium (CaMg)-Induced Adverse Event
Hypokalemia
|
4 Percentage of Participants
|
2 Percentage of Participants
|
|
Incidence of Calcium Magnesium (CaMg)-Induced Adverse Event
Hypomagnesemia
|
0 Percentage of Participants
|
2 Percentage of Participants
|
|
Incidence of Calcium Magnesium (CaMg)-Induced Adverse Event
Hyponatremia
|
4 Percentage of Participants
|
0 Percentage of Participants
|
|
Incidence of Calcium Magnesium (CaMg)-Induced Adverse Event
Infection
|
0 Percentage of Participants
|
2 Percentage of Participants
|
|
Incidence of Calcium Magnesium (CaMg)-Induced Adverse Event
Ischemia-Cerebral
|
0 Percentage of Participants
|
2 Percentage of Participants
|
|
Incidence of Calcium Magnesium (CaMg)-Induced Adverse Event
Ischemia/Infarction
|
2 Percentage of Participants
|
0 Percentage of Participants
|
|
Incidence of Calcium Magnesium (CaMg)-Induced Adverse Event
Laryngeal Discomfort
|
0 Percentage of Participants
|
2 Percentage of Participants
|
|
Incidence of Calcium Magnesium (CaMg)-Induced Adverse Event
Leukopenia
|
6 Percentage of Participants
|
10 Percentage of Participants
|
|
Incidence of Calcium Magnesium (CaMg)-Induced Adverse Event
Muscle Weakness
|
2 Percentage of Participants
|
0 Percentage of Participants
|
|
Incidence of Calcium Magnesium (CaMg)-Induced Adverse Event
Myalgia
|
4 Percentage of Participants
|
0 Percentage of Participants
|
|
Incidence of Calcium Magnesium (CaMg)-Induced Adverse Event
Nausea
|
60 Percentage of Participants
|
71 Percentage of Participants
|
|
Incidence of Calcium Magnesium (CaMg)-Induced Adverse Event
Neuro-motor
|
4 Percentage of Participants
|
4 Percentage of Participants
|
|
Incidence of Calcium Magnesium (CaMg)-Induced Adverse Event
Neuro-sensory
|
2 Percentage of Participants
|
12 Percentage of Participants
|
|
Incidence of Calcium Magnesium (CaMg)-Induced Adverse Event
Neutropenia
|
18 Percentage of Participants
|
33 Percentage of Participants
|
|
Incidence of Calcium Magnesium (CaMg)-Induced Adverse Event
Oral cavity MS CE
|
2 Percentage of Participants
|
0 Percentage of Participants
|
|
Incidence of Calcium Magnesium (CaMg)-Induced Adverse Event
Pain-Abdominal
|
0 Percentage of Participants
|
8 Percentage of Participants
|
|
Incidence of Calcium Magnesium (CaMg)-Induced Adverse Event
Pain-Chest
|
0 Percentage of Participants
|
2 Percentage of Participants
|
|
Incidence of Calcium Magnesium (CaMg)-Induced Adverse Event
Pain-Headache
|
0 Percentage of Participants
|
4 Percentage of Participants
|
|
Incidence of Calcium Magnesium (CaMg)-Induced Adverse Event
Rash/Desquamation
|
4 Percentage of Participants
|
0 Percentage of Participants
|
|
Incidence of Calcium Magnesium (CaMg)-Induced Adverse Event
Skin Rxn-Hand/Foot
|
4 Percentage of Participants
|
2 Percentage of Participants
|
|
Incidence of Calcium Magnesium (CaMg)-Induced Adverse Event
Stomatitis
|
2 Percentage of Participants
|
2 Percentage of Participants
|
|
Incidence of Calcium Magnesium (CaMg)-Induced Adverse Event
Taste
|
2 Percentage of Participants
|
2 Percentage of Participants
|
|
Incidence of Calcium Magnesium (CaMg)-Induced Adverse Event
Thrombocytopenia
|
2 Percentage of Participants
|
2 Percentage of Participants
|
|
Incidence of Calcium Magnesium (CaMg)-Induced Adverse Event
Thrombosis
|
6 Percentage of Participants
|
4 Percentage of Participants
|
|
Incidence of Calcium Magnesium (CaMg)-Induced Adverse Event
Vomiting
|
34 Percentage of Participants
|
33 Percentage of Participants
|
SECONDARY outcome
Timeframe: 127 daysPopulation: Data was collected but not analyzed for this outcome.
Activities of daily living were measured using the Symptom Experience Diary and supplemental quality of life questions. The questionnaires' items were in the scale of 0 (no symptom) to 10 (worst symptom).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and One monthPopulation: Includes all patients with at least one assessment after baseline.
Fatigue was measured by Brief Fatigue Inventory in the scale of 0 (no fatigue) to 10 (fatigue as bad as you can imagine). The item score was reversed and transformed into 0 (low quality of life (QOL)) to 100 (best QOL) scale for analysis. Change: score at one month minus score at baseline.
Outcome measures
| Measure |
Ca/Mg
n=50 Participants
Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
|
Placebo
n=52 Participants
Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
|
|---|---|---|
|
Change From Baseline in Fatigue Score at One Month
Fatigue NOW
|
1.0 units on a scale
Standard Deviation 14.96
|
-2.8 units on a scale
Standard Deviation 17.92
|
|
Change From Baseline in Fatigue Score at One Month
Fatigue USUAL
|
3.1 units on a scale
Standard Deviation 15.38
|
-1.6 units on a scale
Standard Deviation 12.81
|
|
Change From Baseline in Fatigue Score at One Month
Fatigue WORST
|
0.0 units on a scale
Standard Deviation 21.38
|
-1.6 units on a scale
Standard Deviation 18.41
|
SECONDARY outcome
Timeframe: Baseline and One monthPopulation: Includes all patients with at least one assessment after baseline.
Quality of Life (QOL) were measured using the Symptom Experience Diary and supplemental quality of life questions. Item score range: 0 (no symptom) to 10 (worst symptom). The score was reversed and transformed into 0 (low QOL) to 100 (best QOL) scale for analysis. Change: score at one month minus score at baseline.
Outcome measures
| Measure |
Ca/Mg
n=50 Participants
Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
|
Placebo
n=52 Participants
Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
|
|---|---|---|
|
Change From Baseline in Quality of Life (QOL) at One Month
Walking
|
-2.5 Units on a scale
Standard Deviation 11.54
|
0.2 Units on a scale
Standard Deviation 12.78
|
|
Change From Baseline in Quality of Life (QOL) at One Month
Buttoning Shirt or Tying Laces
|
-2.0 Units on a scale
Standard Deviation 9.27
|
0.4 Units on a scale
Standard Deviation 21.07
|
|
Change From Baseline in Quality of Life (QOL) at One Month
Diarrhea
|
-7.1 Units on a scale
Standard Deviation 18.43
|
-10.4 Units on a scale
Standard Deviation 21.77
|
|
Change From Baseline in Quality of Life (QOL) at One Month
Constipation
|
-2.9 Units on a scale
Standard Deviation 14.87
|
0.4 Units on a scale
Standard Deviation 26.94
|
|
Change From Baseline in Quality of Life (QOL) at One Month
Abdominal Cramping
|
-2.5 Units on a scale
Standard Deviation 11.75
|
1.3 Units on a scale
Standard Deviation 23.46
|
|
Change From Baseline in Quality of Life (QOL) at One Month
Bowel Problems with Normal Activity
|
-3.2 Units on a scale
Standard Deviation 18.06
|
-9.1 Units on a scale
Standard Deviation 19.05
|
|
Change From Baseline in Quality of Life (QOL) at One Month
Fatigue WORST
|
0.0 Units on a scale
Standard Deviation 21.38
|
-1.6 Units on a scale
Standard Deviation 18.41
|
|
Change From Baseline in Quality of Life (QOL) at One Month
Shortness of Breath (Week 2 - Baseline)
|
-0.7 Units on a scale
Standard Deviation 7.16
|
2.1 Units on a scale
Standard Deviation 22.26
|
|
Change From Baseline in Quality of Life (QOL) at One Month
Swallowing (Week 2 - Baseline)
|
-7.5 Units on a scale
Standard Deviation 17.56
|
2.1 Units on a scale
Standard Deviation 21.87
|
|
Change From Baseline in Quality of Life (QOL) at One Month
Numbness in Fingers, Toes (Week 2 - Baseline)
|
-8.3 Units on a scale
Standard Deviation 16.49
|
-9.6 Units on a scale
Standard Deviation 15.74
|
|
Change From Baseline in Quality of Life (QOL) at One Month
Tingling in Fingers, Toes (Week 2 - Baseline)
|
-14.8 Units on a scale
Standard Deviation 21.65
|
-20.4 Units on a scale
Standard Deviation 20.53
|
Adverse Events
Ca/Mg
Serious events: 2 serious events
Other events: 48 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 46 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ca/Mg
n=50 participants at risk
Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
|
Placebo
n=52 participants at risk
Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
2.0%
1/50 • Number of events 1 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
0.00%
0/52 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
|
Investigations
Neutrophil count decreased
|
2.0%
1/50 • Number of events 1 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
1.9%
1/52 • Number of events 1 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
2.0%
1/50 • Number of events 1 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
0.00%
0/52 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
Other adverse events
| Measure |
Ca/Mg
n=50 participants at risk
Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
|
Placebo
n=52 participants at risk
Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
|
|---|---|---|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
4.0%
2/50 • Number of events 2 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
3.8%
2/52 • Number of events 4 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
|
Cardiac disorders
Myocardial ischemia
|
2.0%
1/50 • Number of events 1 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
0.00%
0/52 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/50 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
7.7%
4/52 • Number of events 4 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
|
Gastrointestinal disorders
Constipation
|
50.0%
25/50 • Number of events 87 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
50.0%
26/52 • Number of events 75 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
|
Gastrointestinal disorders
Diarrhea
|
74.0%
37/50 • Number of events 144 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
76.9%
40/52 • Number of events 170 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
2.0%
1/50 • Number of events 1 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
0.00%
0/52 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
|
Gastrointestinal disorders
Esophageal mucositis
|
0.00%
0/50 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
1.9%
1/52 • Number of events 1 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
|
Gastrointestinal disorders
Mucositis oral
|
2.0%
1/50 • Number of events 6 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
1.9%
1/52 • Number of events 2 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
|
Gastrointestinal disorders
Nausea
|
64.0%
32/50 • Number of events 133 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
73.1%
38/52 • Number of events 150 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/50 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
1.9%
1/52 • Number of events 1 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
|
Gastrointestinal disorders
Vomiting
|
38.0%
19/50 • Number of events 39 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
36.5%
19/52 • Number of events 41 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
|
General disorders
Chest pain
|
0.00%
0/50 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
1.9%
1/52 • Number of events 1 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
|
General disorders
Fatigue
|
14.0%
7/50 • Number of events 15 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
25.0%
13/52 • Number of events 22 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
|
Hepatobiliary disorders
Cholecystitis
|
2.0%
1/50 • Number of events 1 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
0.00%
0/52 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
|
Immune system disorders
Hypersensitivity
|
8.0%
4/50 • Number of events 4 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
0.00%
0/52 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
|
Infections and infestations
Abdominal infection
|
2.0%
1/50 • Number of events 1 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
0.00%
0/52 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
|
Infections and infestations
Colitis, infectious (e.g., Clostridium difficile)
|
0.00%
0/50 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
1.9%
1/52 • Number of events 2 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
|
Infections and infestations
Infection
|
0.00%
0/50 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
1.9%
1/52 • Number of events 1 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
2.0%
1/50 • Number of events 4 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
0.00%
0/52 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
|
Investigations
Alanine aminotransferase increased
|
2.0%
1/50 • Number of events 1 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
0.00%
0/52 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
|
Investigations
Alkaline phosphatase increased
|
2.0%
1/50 • Number of events 2 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
0.00%
0/52 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
|
Investigations
Aspartate aminotransferase increased
|
2.0%
1/50 • Number of events 1 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
0.00%
0/52 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
|
Investigations
Leukocyte count decreased
|
6.0%
3/50 • Number of events 8 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
11.5%
6/52 • Number of events 8 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
|
Investigations
Neutrophil count decreased
|
18.0%
9/50 • Number of events 18 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
38.5%
20/52 • Number of events 24 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
|
Investigations
Platelet count decreased
|
4.0%
2/50 • Number of events 2 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
5.8%
3/52 • Number of events 4 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
|
Investigations
Weight loss
|
2.0%
1/50 • Number of events 2 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
1.9%
1/52 • Number of events 3 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
|
Metabolism and nutrition disorders
Anorexia
|
6.0%
3/50 • Number of events 5 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
1.9%
1/52 • Number of events 1 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
2.0%
1/50 • Number of events 1 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
0.00%
0/52 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.0%
1/50 • Number of events 1 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
5.8%
3/52 • Number of events 4 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
|
Metabolism and nutrition disorders
Serum calcium increased
|
0.00%
0/50 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
3.8%
2/52 • Number of events 3 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
|
Metabolism and nutrition disorders
Serum magnesium decreased
|
2.0%
1/50 • Number of events 1 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
1.9%
1/52 • Number of events 1 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
|
Metabolism and nutrition disorders
Serum magnesium increased
|
18.0%
9/50 • Number of events 21 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
19.2%
10/52 • Number of events 39 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
4.0%
2/50 • Number of events 3 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
5.8%
3/52 • Number of events 3 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
4.0%
2/50 • Number of events 4 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
0.00%
0/52 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
2.0%
1/50 • Number of events 1 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
0.00%
0/52 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.0%
2/50 • Number of events 2 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
1.9%
1/52 • Number of events 2 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
|
Nervous system disorders
Dysgeusia
|
2.0%
1/50 • Number of events 1 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
1.9%
1/52 • Number of events 1 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
|
Nervous system disorders
Headache
|
2.0%
1/50 • Number of events 2 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
3.8%
2/52 • Number of events 2 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
|
Nervous system disorders
Ischemia cerebrovascular
|
0.00%
0/50 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
1.9%
1/52 • Number of events 1 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/50 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
1.9%
1/52 • Number of events 1 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
8.0%
4/50 • Number of events 12 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
5.8%
3/52 • Number of events 3 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
20.0%
10/50 • Number of events 28 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
25.0%
13/52 • Number of events 29 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal pain
|
0.00%
0/50 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
1.9%
1/52 • Number of events 1 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal examination abnormal
|
0.00%
0/50 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
1.9%
1/52 • Number of events 2 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/50 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
1.9%
1/52 • Number of events 1 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
4.0%
2/50 • Number of events 2 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
0.00%
0/52 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
|
Skin and subcutaneous tissue disorders
Hand-and-foot syndrome
|
6.0%
3/50 • Number of events 4 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
5.8%
3/52 • Number of events 4 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
2.0%
1/50 • Number of events 1 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
3.8%
2/52 • Number of events 2 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
4.0%
2/50 • Number of events 7 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
0.00%
0/52 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/50 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
1.9%
1/52 • Number of events 1 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
|
Vascular disorders
Hypotension
|
2.0%
1/50 • Number of events 1 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
0.00%
0/52 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
|
Vascular disorders
Thrombosis
|
6.0%
3/50 • Number of events 7 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
5.8%
3/52 • Number of events 5 • Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place