Trial Outcomes & Findings for Macrogol 3350-based Oral Osmotic Laxative in Preventing Cancer in Patients at Risk of Colorectal Cancer (NCT NCT00828984)
NCT ID: NCT00828984
Last Updated: 2017-04-18
Results Overview
Evaluate the effect of polyethylene glycol (PEG) 3350 (administered at 8g or 17g/day for six months) versus placebo on EGFR expression.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
87 participants
Primary outcome timeframe
6 months - baseline
Results posted on
2017-04-18
Participant Flow
Age 18 and older; Recruitment sites: NorthShore University HealthSystem, University of Chicago, Boston University (no accrual occurred)
History of any size adenoma or colon cancer within the last 6 years;
Participant milestones
| Measure |
Arm A (High-dose PEG 3350)
Patients receive high-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.
17g day/macrogol 3350-based oral osmotic laxative: Given PO
Laboratory Biomarker Analysis: Correlative studies
|
Arm B (Low-dose Polyethylene Glycol)
Patients receive low-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.
8g day/macrogol 3350-based oral osmotic laxative: Given PO
Laboratory Biomarker Analysis: Correlative studies
|
Arm C (Placebo)
Patients receive placebo PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.
Placebo: Given PO
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|---|---|
|
Overall Study
STARTED
|
28
|
31
|
28
|
|
Overall Study
Randomization
|
28
|
31
|
28
|
|
Overall Study
Treatment
|
24
|
26
|
24
|
|
Overall Study
Flexible Sigmoidoscopy
|
20
|
19
|
19
|
|
Overall Study
Post Intervention Follow-Up
|
15
|
16
|
19
|
|
Overall Study
COMPLETED
|
14
|
15
|
19
|
|
Overall Study
NOT COMPLETED
|
14
|
16
|
9
|
Reasons for withdrawal
| Measure |
Arm A (High-dose PEG 3350)
Patients receive high-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.
17g day/macrogol 3350-based oral osmotic laxative: Given PO
Laboratory Biomarker Analysis: Correlative studies
|
Arm B (Low-dose Polyethylene Glycol)
Patients receive low-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.
8g day/macrogol 3350-based oral osmotic laxative: Given PO
Laboratory Biomarker Analysis: Correlative studies
|
Arm C (Placebo)
Patients receive placebo PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.
Placebo: Given PO
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
3
|
0
|
|
Overall Study
Lost to Follow-up
|
5
|
3
|
1
|
|
Overall Study
Withdrawal by Subject
|
4
|
4
|
4
|
|
Overall Study
Ineligable
|
1
|
2
|
0
|
|
Overall Study
Medical Contraindication
|
0
|
1
|
0
|
|
Overall Study
Noncompliant
|
1
|
2
|
3
|
|
Overall Study
ConMed
|
1
|
1
|
1
|
Baseline Characteristics
Macrogol 3350-based Oral Osmotic Laxative in Preventing Cancer in Patients at Risk of Colorectal Cancer
Baseline characteristics by cohort
| Measure |
Arm A (High-dose PEG 3350)
n=28 Participants
Patients receive high-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.
macrogol 3350-based oral osmotic laxative: Given PO
Laboratory Biomarker Analysis: Correlative studies
|
Arm B (Low-dose Polyethylene Glycol)
n=31 Participants
Patients receive low-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.
macrogol 3350-based oral osmotic laxative: Given PO
Laboratory Biomarker Analysis: Correlative studies
|
Arm C (Placebo)
n=28 Participants
Patients receive placebo PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.
Placebo: Given PO
Laboratory Biomarker Analysis: Correlative studies
|
Total
n=87 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
84 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
76 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 6 months - baselinePopulation: The study population includes men and women of all races and ethnicities who are scheduled to undergo colonoscopy for a history of colonic neoplasia (within the past 6 years of either colonic adenoma ≥ 5 mm or carcinoma).
Evaluate the effect of polyethylene glycol (PEG) 3350 (administered at 8g or 17g/day for six months) versus placebo on EGFR expression.
Outcome measures
| Measure |
Arm A (High-dose PEG 3350)
n=14 Participants
Patients receive high-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.
17g day/macrogol 3350-based oral osmotic laxative: Given PO
Laboratory Biomarker Analysis: Correlative studies
|
Arm B (Low-dose Polyethylene Glycol)
n=15 Participants
Patients receive low-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.
8g day/macrogol 3350-based oral osmotic laxative: Given PO
Laboratory Biomarker Analysis: Correlative studies
|
Arm C (Placebo)
n=19 Participants
Patients receive placebo PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.
Placebo: Given PO
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|---|---|
|
Difference (After Treatment Minus Before Treatment) of EGFR Expression
|
0.17 ng/ml
Standard Deviation 1.07
|
-0.40 ng/ml
Standard Deviation 0.66
|
0.21 ng/ml
Standard Deviation 0.67
|
SECONDARY outcome
Timeframe: 6 months - baselinePopulation: The study population includes men and women of all races and ethnicities who are scheduled to undergo colonoscopy for a history of colonic neoplasia (within the past 6 years of either colonic adenoma ≥ 5 mm or carcinoma).
To determine the effect of PEG 3350 on aberrant crypt foci (ACF) number and to compare the reduction in ACF number between the low dose (8g PEG 3350 / day) and higher dose (17g PEG 3350 / day) groups
Outcome measures
| Measure |
Arm A (High-dose PEG 3350)
n=14 Participants
Patients receive high-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.
17g day/macrogol 3350-based oral osmotic laxative: Given PO
Laboratory Biomarker Analysis: Correlative studies
|
Arm B (Low-dose Polyethylene Glycol)
n=15 Participants
Patients receive low-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.
8g day/macrogol 3350-based oral osmotic laxative: Given PO
Laboratory Biomarker Analysis: Correlative studies
|
Arm C (Placebo)
n=19 Participants
Patients receive placebo PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.
Placebo: Given PO
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|---|---|
|
Change in ACF Count as Measured in Endoscopically Normal (Non-ACF) Mucosal Biopsies
|
2.11 Aberrant Crypt Foci
Standard Deviation 4.63
|
1 Aberrant Crypt Foci
Standard Deviation 1.73
|
-0.73 Aberrant Crypt Foci
Standard Deviation 2.74
|
SECONDARY outcome
Timeframe: 6 months - baselinePopulation: To determine the effect of PEG 3350 on aberrant crypt foci (ACF) number and to compare the reduction in ACF number between the low dose (8g PEG 3350 / day) and higher dose (17g PEG 3350 / day) groups.
To determine the effect of PEG 3350 on mucosal epithelial proliferation (Ki-67)
Outcome measures
| Measure |
Arm A (High-dose PEG 3350)
n=14 Participants
Patients receive high-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.
17g day/macrogol 3350-based oral osmotic laxative: Given PO
Laboratory Biomarker Analysis: Correlative studies
|
Arm B (Low-dose Polyethylene Glycol)
n=15 Participants
Patients receive low-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.
8g day/macrogol 3350-based oral osmotic laxative: Given PO
Laboratory Biomarker Analysis: Correlative studies
|
Arm C (Placebo)
n=19 Participants
Patients receive placebo PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.
Placebo: Given PO
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|---|---|
|
Change in Ki-67 (Proliferation) Expression as Measured in Endoscopically Normal (Non-ACF) Mucosal Biopsies
|
2.74 ng/ml
Standard Deviation 5.20
|
-0.86 ng/ml
Standard Deviation 6.62
|
-3.58 ng/ml
Standard Deviation 11.84
|
SECONDARY outcome
Timeframe: 6 months - baselinePopulation: The study population includes men and women of all races and ethnicities who are scheduled to undergo colonoscopy for a history of colonic neoplasia (within the past 6 years of either colonic adenoma ≥ 5 mm or carcinoma).
Change in activated caspase-3 (apoptosis) expression as measured in endoscopically normal (non-ACF) mucosal biopsies
Outcome measures
| Measure |
Arm A (High-dose PEG 3350)
n=14 Participants
Patients receive high-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.
17g day/macrogol 3350-based oral osmotic laxative: Given PO
Laboratory Biomarker Analysis: Correlative studies
|
Arm B (Low-dose Polyethylene Glycol)
n=15 Participants
Patients receive low-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.
8g day/macrogol 3350-based oral osmotic laxative: Given PO
Laboratory Biomarker Analysis: Correlative studies
|
Arm C (Placebo)
n=19 Participants
Patients receive placebo PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.
Placebo: Given PO
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|---|---|
|
Change in Mucosal Apoptosis (Cleaved Caspase-3) as Measured in Endoscopically Normal (Non-ACF) Mucosal Biopsies
|
-0.27 ng/ml
Standard Deviation 2.97
|
0.25 ng/ml
Standard Deviation 3.18
|
-0.15 ng/ml
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: 6 months - baselinePopulation: The study population includes men and women of all races and ethnicities who are scheduled to undergo colonoscopy for a history of colonic neoplasia (within the past 6 years of either colonic adenoma ≥ 5 mm or carcinoma).
Outcome measures
| Measure |
Arm A (High-dose PEG 3350)
n=14 Participants
Patients receive high-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.
17g day/macrogol 3350-based oral osmotic laxative: Given PO
Laboratory Biomarker Analysis: Correlative studies
|
Arm B (Low-dose Polyethylene Glycol)
n=15 Participants
Patients receive low-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.
8g day/macrogol 3350-based oral osmotic laxative: Given PO
Laboratory Biomarker Analysis: Correlative studies
|
Arm C (Placebo)
n=19 Participants
Patients receive placebo PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.
Placebo: Given PO
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|---|---|
|
Change in SNAIL Expression as Measured in Endoscopically Normal (Non-ACF) Mucosal Biopsies
|
0.45 ng/ml
Standard Deviation 0.58
|
0.55 ng/ml
Standard Deviation 0.88
|
0.08 ng/ml
Standard Deviation 0.70
|
SECONDARY outcome
Timeframe: 6 months - baselinePopulation: The study population includes men and women of all races and ethnicities who are scheduled to undergo colonoscopy for a history of colonic neoplasia (within the past 6 years of either colonic adenoma ≥ 5 mm or carcinoma).
Outcome measures
| Measure |
Arm A (High-dose PEG 3350)
n=14 Participants
Patients receive high-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.
17g day/macrogol 3350-based oral osmotic laxative: Given PO
Laboratory Biomarker Analysis: Correlative studies
|
Arm B (Low-dose Polyethylene Glycol)
n=15 Participants
Patients receive low-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.
8g day/macrogol 3350-based oral osmotic laxative: Given PO
Laboratory Biomarker Analysis: Correlative studies
|
Arm C (Placebo)
n=19 Participants
Patients receive placebo PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.
Placebo: Given PO
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|---|---|
|
Change in E-cadherin Expression as Measured in Endoscopically Normal (Non-ACF) Mucosal Biopsies
|
-0.17 ng/ml
Standard Deviation 1.75
|
0.15 ng/ml
Standard Deviation 0.59
|
-0.18 ng/ml
Standard Deviation 0.82
|
Adverse Events
Arm A (High-dose PEG 3350)
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Arm B (Low-dose Polyethylene Glycol)
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
Arm C (Placebo)
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A (High-dose PEG 3350)
n=28 participants at risk
Patients receive high-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.
17g day/macrogol 3350-based oral osmotic laxative: Given PO
Laboratory Biomarker Analysis: Correlative studies
|
Arm B (Low-dose Polyethylene Glycol)
n=31 participants at risk
Patients receive low-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.
8g day/macrogol 3350-based oral osmotic laxative: Given PO
Laboratory Biomarker Analysis: Correlative studies
|
Arm C (Placebo)
n=28 participants at risk
Patients receive placebo PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.
Placebo: Given PO
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Hemorrgae/Bleeding,CNS
|
0.00%
0/28 • 6 months
|
0.00%
0/31 • 6 months
|
3.6%
1/28 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Perforation,GI: Colon
|
0.00%
0/28 • 6 months
|
3.2%
1/31 • Number of events 1 • 6 months
|
0.00%
0/28 • 6 months
|
|
Infections and infestations
Infection - Other
|
0.00%
0/28 • 6 months
|
0.00%
0/31 • 6 months
|
3.6%
1/28 • Number of events 1 • 6 months
|
Other adverse events
| Measure |
Arm A (High-dose PEG 3350)
n=28 participants at risk
Patients receive high-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.
17g day/macrogol 3350-based oral osmotic laxative: Given PO
Laboratory Biomarker Analysis: Correlative studies
|
Arm B (Low-dose Polyethylene Glycol)
n=31 participants at risk
Patients receive low-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.
8g day/macrogol 3350-based oral osmotic laxative: Given PO
Laboratory Biomarker Analysis: Correlative studies
|
Arm C (Placebo)
n=28 participants at risk
Patients receive placebo PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.
Placebo: Given PO
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Edema; Limb
|
0.00%
0/28 • 6 months
|
3.2%
1/31 • Number of events 1 • 6 months
|
3.6%
1/28 • Number of events 1 • 6 months
|
|
Blood and lymphatic system disorders
Hemorrhage, GI: Rectum
|
0.00%
0/28 • 6 months
|
3.2%
1/31 • Number of events 1 • 6 months
|
0.00%
0/28 • 6 months
|
|
Cardiac disorders
Cardiac arrythmia: Supraventricular and nodal arrhythmia: Atrial fibrillation
|
0.00%
0/28 • 6 months
|
0.00%
0/31 • 6 months
|
3.6%
1/28 • Number of events 1 • 6 months
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/28 • 6 months
|
3.2%
1/31 • Number of events 1 • 6 months
|
0.00%
0/28 • 6 months
|
|
Ear and labyrinth disorders
Otitis, Middle Ear (Non-Infectious)
|
0.00%
0/28 • 6 months
|
0.00%
0/31 • 6 months
|
3.6%
1/28 • Number of events 1 • 6 months
|
|
Ear and labyrinth disorders
Otitis, External Ear (Non-Infectious)
|
0.00%
0/28 • 6 months
|
0.00%
0/31 • 6 months
|
3.6%
1/28 • Number of events 1 • 6 months
|
|
Endocrine disorders
Endocrine - Other (Specify, __)
|
28.6%
8/28 • Number of events 17 • 6 months
|
3.2%
1/31 • Number of events 1 • 6 months
|
0.00%
0/28 • 6 months
|
|
Gastrointestinal disorders
Diarrhea
|
28.6%
8/28 • Number of events 8 • 6 months
|
12.9%
4/31 • Number of events 5 • 6 months
|
14.3%
4/28 • Number of events 5 • 6 months
|
|
Gastrointestinal disorders
Flatulence
|
7.1%
2/28 • Number of events 8 • 6 months
|
6.5%
2/31 • Number of events 2 • 6 months
|
10.7%
3/28 • Number of events 4 • 6 months
|
|
Gastrointestinal disorders
Distention/bloating, Abdominal
|
21.4%
6/28 • Number of events 13 • 6 months
|
9.7%
3/31 • Number of events 4 • 6 months
|
10.7%
3/28 • Number of events 5 • 6 months
|
|
Gastrointestinal disorders
Heartburn/Dyspepsia
|
0.00%
0/28 • 6 months
|
3.2%
1/31 • Number of events 2 • 6 months
|
0.00%
0/28 • 6 months
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/28 • 6 months
|
6.5%
2/31 • Number of events 2 • 6 months
|
0.00%
0/28 • 6 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/28 • 6 months
|
0.00%
0/31 • 6 months
|
3.6%
1/28 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Nausea
|
3.6%
1/28 • Number of events 1 • 6 months
|
0.00%
0/31 • 6 months
|
3.6%
1/28 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Gastrointestinal - Other (Specify)
|
7.1%
2/28 • Number of events 2 • 6 months
|
0.00%
0/31 • 6 months
|
0.00%
0/28 • 6 months
|
|
General disorders
Pain: Pain Nos
|
0.00%
0/28 • 6 months
|
3.2%
1/31 • Number of events 1 • 6 months
|
0.00%
0/28 • 6 months
|
|
General disorders
Pain - Other (Specify, __)
|
0.00%
0/28 • 6 months
|
3.2%
1/31 • Number of events 4 • 6 months
|
0.00%
0/28 • 6 months
|
|
General disorders
Pain: Muscle
|
0.00%
0/28 • 6 months
|
3.2%
1/31 • Number of events 1 • 6 months
|
0.00%
0/28 • 6 months
|
|
General disorders
Pain: Abdomen Nos
|
7.1%
2/28 • Number of events 6 • 6 months
|
3.2%
1/31 • Number of events 1 • 6 months
|
14.3%
4/28 • Number of events 6 • 6 months
|
|
General disorders
Pain: Joint
|
0.00%
0/28 • 6 months
|
3.2%
1/31 • Number of events 2 • 6 months
|
7.1%
2/28 • Number of events 8 • 6 months
|
|
General disorders
Pain: Neuralgia/Peripheral Nerve
|
0.00%
0/28 • 6 months
|
3.2%
1/31 • Number of events 1 • 6 months
|
0.00%
0/28 • 6 months
|
|
General disorders
Pain: Throat/Pharynx/Larynx
|
0.00%
0/28 • 6 months
|
3.2%
1/31 • Number of events 1 • 6 months
|
0.00%
0/28 • 6 months
|
|
General disorders
Pain: Stomach
|
0.00%
0/28 • 6 months
|
0.00%
0/31 • 6 months
|
3.6%
1/28 • Number of events 1 • 6 months
|
|
General disorders
Pain: Rectum
|
0.00%
0/28 • 6 months
|
0.00%
0/31 • 6 months
|
3.6%
1/28 • Number of events 1 • 6 months
|
|
General disorders
Pain: Chest/Thorax Nos
|
0.00%
0/28 • 6 months
|
0.00%
0/31 • 6 months
|
3.6%
1/28 • Number of events 1 • 6 months
|
|
General disorders
Pain: Back
|
3.6%
1/28 • Number of events 1 • 6 months
|
0.00%
0/31 • 6 months
|
3.6%
1/28 • Number of events 1 • 6 months
|
|
General disorders
Pain: Dental/Teeth/Peridontal
|
0.00%
0/28 • 6 months
|
0.00%
0/31 • 6 months
|
3.6%
1/28 • Number of events 1 • 6 months
|
|
General disorders
Pain: Headache
|
3.6%
1/28 • Number of events 1 • 6 months
|
0.00%
0/31 • 6 months
|
0.00%
0/28 • 6 months
|
|
General disorders
"Constitutional Symptoms: Fever (In the absence of Neutropenia, where Neutropenia is defined as ANC
|
0.00%
0/28 • 6 months
|
3.2%
1/31 • Number of events 1 • 6 months
|
0.00%
0/28 • 6 months
|
|
General disorders
Constitutional Symptoms: Fatigue (Asthenia, Lethargy, Malaise)
|
0.00%
0/28 • 6 months
|
0.00%
0/31 • 6 months
|
3.6%
1/28 • Number of events 1 • 6 months
|
|
General disorders
Syndromes: Flu-like Syndrome
|
0.00%
0/28 • 6 months
|
6.5%
2/31 • Number of events 6 • 6 months
|
0.00%
0/28 • 6 months
|
|
Immune system disorders
Allergic Rhinitis (Including sneezing, nasal stuffiness, postnasal drip)
|
0.00%
0/28 • 6 months
|
6.5%
2/31 • Number of events 2 • 6 months
|
7.1%
2/28 • Number of events 2 • 6 months
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 Neutrophils: Nerve-Peripheral
|
0.00%
0/28 • 6 months
|
3.2%
1/31 • Number of events 1 • 6 months
|
0.00%
0/28 • 6 months
|
|
Infections and infestations
Infection with unknown ANC: Upper Airway Nos
|
0.00%
0/28 • 6 months
|
3.2%
1/31 • Number of events 1 • 6 months
|
0.00%
0/28 • 6 months
|
|
Infections and infestations
Infection - Other (Specify, __)
|
0.00%
0/28 • 6 months
|
3.2%
1/31 • Number of events 1 • 6 months
|
0.00%
0/28 • 6 months
|
|
Infections and infestations
Infection with unknown ANC: Pharynx
|
0.00%
0/28 • 6 months
|
3.2%
1/31 • Number of events 1 • 6 months
|
3.6%
1/28 • Number of events 1 • 6 months
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 Neutrophils: Upper Airway Nos
|
0.00%
0/28 • 6 months
|
3.2%
1/31 • Number of events 1 • 6 months
|
3.6%
1/28 • Number of events 2 • 6 months
|
|
Infections and infestations
Infection with unknown ANC: Skin (Cellulitis)
|
0.00%
0/28 • 6 months
|
0.00%
0/31 • 6 months
|
3.6%
1/28 • Number of events 1 • 6 months
|
|
Infections and infestations
"Infection (documented clinically or microbiologically) with grade 3 or 4 neutrophils (ANC <1.0 X 1
|
0.00%
0/28 • 6 months
|
0.00%
0/31 • 6 months
|
3.6%
1/28 • Number of events 1 • 6 months
|
|
Infections and infestations
Infection with unknown ANC: Nerve-Peripheral
|
0.00%
0/28 • 6 months
|
0.00%
0/31 • 6 months
|
3.6%
1/28 • Number of events 1 • 6 months
|
|
Infections and infestations
Infection with unknown ANC: Dental-tooth
|
0.00%
0/28 • 6 months
|
0.00%
0/31 • 6 months
|
3.6%
1/28 • Number of events 1 • 6 months
|
|
Infections and infestations
Infection with unknown ANC: Sinus
|
0.00%
0/28 • 6 months
|
0.00%
0/31 • 6 months
|
3.6%
1/28 • Number of events 1 • 6 months
|
|
Infections and infestations
Infection with unknown ANC: Bladder (Urinary)
|
3.6%
1/28 • Number of events 1 • 6 months
|
0.00%
0/31 • 6 months
|
0.00%
0/28 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft tissue - Other (Specify, __)
|
0.00%
0/28 • 6 months
|
3.2%
1/31 • Number of events 1 • 6 months
|
0.00%
0/28 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft tissue - Arthritis (non-septic)
|
0.00%
0/28 • 6 months
|
0.00%
0/31 • 6 months
|
7.1%
2/28 • Number of events 2 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory: Nasal Cavity/Paranasal Sinus Reactions
|
0.00%
0/28 • 6 months
|
3.2%
1/31 • Number of events 1 • 6 months
|
0.00%
0/28 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory: Cough
|
0.00%
0/28 • 6 months
|
6.5%
2/31 • Number of events 2 • 6 months
|
0.00%
0/28 • 6 months
|
|
Skin and subcutaneous tissue disorders
Rash/Desquamation
|
0.00%
0/28 • 6 months
|
3.2%
1/31 • Number of events 1 • 6 months
|
0.00%
0/28 • 6 months
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/28 • 6 months
|
0.00%
0/31 • 6 months
|
3.6%
1/28 • Number of events 1 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60