Trial Outcomes & Findings for Erlotinib Hydrochloride in Reducing Duodenal Polyp Burden in Patients With Familial Adenomatous Polyposis at Risk of Developing Colon Cancer (NCT NCT02961374)
NCT ID: NCT02961374
Last Updated: 2022-07-26
Results Overview
Assessed by esophagogastroduodenoscopy, the mean percent change was calculated by subtracting the sum of diameters from all polyps at baseline from the sum of diameters of all polyps at 6 months, then dividing by the sum of diameters from all polyps at baseline and multiplying by 100.
COMPLETED
PHASE2
46 participants
Baseline to 6 months post-intervention
2022-07-26
Participant Flow
Participant milestones
| Measure |
Treatment (Erlotinib Hydrochloride)
Patients receive 350 mg erlotinib hydrochloride PO once weekly. Treatment continues for up to 6 months in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
STARTED
|
46
|
|
Overall Study
COMPLETED
|
42
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Treatment (Erlotinib Hydrochloride)
Patients receive 350 mg erlotinib hydrochloride PO once weekly. Treatment continues for up to 6 months in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
Adverse Event
|
4
|
Baseline Characteristics
Erlotinib Hydrochloride in Reducing Duodenal Polyp Burden in Patients With Familial Adenomatous Polyposis at Risk of Developing Colon Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Erlotinib Hydrochloride)
n=46 Participants
Patients receive 350 mg erlotinib hydrochloride PO once weekly. Treatment continues for up to 6 months in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Age, Continuous
|
42 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
40 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
43 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Puerto Rico
|
4 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
42 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 6 months post-interventionPopulation: Of the 46 patients registered, 42 patients began protocol treatment and were assessed at both baseline and at the 6 month timepoint.
Assessed by esophagogastroduodenoscopy, the mean percent change was calculated by subtracting the sum of diameters from all polyps at baseline from the sum of diameters of all polyps at 6 months, then dividing by the sum of diameters from all polyps at baseline and multiplying by 100.
Outcome measures
| Measure |
Treatment (Erlotinib Hydrochloride)
n=42 Participants
Patients receive 350 mg erlotinib hydrochloride PO once weekly. Treatment continues for up to 6 months in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Mean Percent Change in Duodenal Polyp Burden
|
-29.6 percent change in Duodenal Polyp Burden
Interval -39.6 to -19.7
|
PRIMARY outcome
Timeframe: Up to 7 months from registrationPopulation: All patients that registered and completed one course of treatment are included in this analysis.
Assessed according to National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The number of patients reporting a grade 2 or higher event are reported.
Outcome measures
| Measure |
Treatment (Erlotinib Hydrochloride)
n=46 Participants
Patients receive 350 mg erlotinib hydrochloride PO once weekly. Treatment continues for up to 6 months in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Number of Participants With Grade 2/3 Adverse Event (AE)
|
33 Participants
|
SECONDARY outcome
Timeframe: Up to 7 months from registrationPopulation: All registered patients that began protocol treatment and were assessed for adverse events are included in this analysis.
Assessed according to NCI CTCAE version 4.0. All registered and treated participants will be evaluable for AEs from the time of their first dose of weekly erlotinib treatment. To evaluate the AE profile for this treatment, the maximum grade for each type of adverse event will be recorded for each participant and frequency tables will be reviewed to determine the overall patterns. The number of patients reporting a grade 1 or higher adverse event at least possibly related to treatment are reported.
Outcome measures
| Measure |
Treatment (Erlotinib Hydrochloride)
n=46 Participants
Patients receive 350 mg erlotinib hydrochloride PO once weekly. Treatment continues for up to 6 months in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Number of Participants With Any Adverse Events
|
41 Participants
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: All patients that began protocol therapy and were assessed for duodenal polyp number at baseline and after 6 months are included in this analysis.
The number of duodenal polyps at baseline and the number of polyps remaining after 6 months of treatment will collected. The change in duodenal polyp number will be calculated for each patient by subtracting the baseline number of polyps from the 6 month number. Therefore a negative value indicates a decrease in the number of polyps present after 6 months. The median difference and standard deviation is reported.
Outcome measures
| Measure |
Treatment (Erlotinib Hydrochloride)
n=42 Participants
Patients receive 350 mg erlotinib hydrochloride PO once weekly. Treatment continues for up to 6 months in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Change in Duodenal Polyp Number
|
-12.8 polyps
Standard Deviation 22.96
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: All registered participants who reported an average lower GI polyp diameter at both baseline and assessed at month 6 and were evaluable for change in lower GI polyp number.
Lower GI polyp burden was defined using the Pouch Exam form as either 1) the average diameter reported for pouch for participants with ileal pouch-anal anastomosis (IPAA), or 2) the average diameter reported for rectum for participants with ileorectal anastomosis (IRA) + rectal stump. Absolute change from baseline to month 6 are reported here.
Outcome measures
| Measure |
Treatment (Erlotinib Hydrochloride)
n=11 Participants
Patients receive 350 mg erlotinib hydrochloride PO once weekly. Treatment continues for up to 6 months in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Absolute Change in Lower Gastrointestinal Polyp Burden
|
0 polyps
Interval 0.0 to 1.0
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: All registered participants who reported an average lower GI polyp diameter at both baseline and assessed at month 6 and were evaluable for change in lower GI polyp number.
Lower GI polyp burden was defined using the Pouch Exam form as either 1) the average diameter reported for pouch for participants with ileal pouch-anal anastomosis (IPAA), or 2) the average diameter reported for rectum for participants with ileorectal anastomosis (IRA) + rectal stump. The percent change from baseline to month 6 are reported here.
Outcome measures
| Measure |
Treatment (Erlotinib Hydrochloride)
n=11 Participants
Patients receive 350 mg erlotinib hydrochloride PO once weekly. Treatment continues for up to 6 months in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Percent Change in Lower Gastrointestinal Polyp Burden
|
0 Percent change in polyp burden
Interval 0.0 to 25.0
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: All registered participants who reported total number of lower GI polyps at baseline and assessed at month 6 and were evaluable for change in lower GI polyp number.
Lower GI polyp number was defined using the Pouch Exam form as either 1) the number of polyps reported for pouch for participants with ileal pouch-anal anastomosis (IPAA), or 2) the number of polyps reported for rectum for participants with ileorectal anastomosis (IRA) + rectal stump. Absolute change from baseline to month 6 are reported here.
Outcome measures
| Measure |
Treatment (Erlotinib Hydrochloride)
n=18 Participants
Patients receive 350 mg erlotinib hydrochloride PO once weekly. Treatment continues for up to 6 months in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Absolute Change in Lower Gastrointestinal Polyp Number
|
-6 Change in the polyp number
Interval -26.0 to 0.0
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: All registered participants who reported total number of lower GI polyps at baseline and assessed at month 6 and were evaluable for change in lower GI polyp number.
Lower GI polyp number was defined using the Pouch Exam form as either 1) the number of polyps reported for pouch for participants with IPAA, or 2) the number of polyps reported for rectum for participants with IRA + rectal stump.
Outcome measures
| Measure |
Treatment (Erlotinib Hydrochloride)
n=18 Participants
Patients receive 350 mg erlotinib hydrochloride PO once weekly. Treatment continues for up to 6 months in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Percent Change in Lower Gastrointestinal Polyp Number
|
-30.8 percent change in polyp number
Interval -47.4 to 0.0
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: Data on desmoid tumor size was not collected.
Laboratory measures will be correlated with participant outcomes (i.e., polyp burden, adverse events) and with each other as well. Cut-points will be determined based on previously defined and accepted standards. Descriptive statistics and simple scatter plots will be generated to review the tissue-based biomarker data. For continuous variables, the actual and % change in the level of each of the biomarkers from pre- to post-intervention will be explored using Wilcoxon signed rank tests, and paired sample t-tests. All categorical variables will be analyzed using chi-square tests or Fisher's exact test. For all translational endpoints, any notable statistical result will be viewed as an impetus for further study rather than as a definitive finding in and of itself.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 2.5 yearsLaboratory measures will be correlated with participant outcomes (i.e., polyp burden, adverse events) and with each other as well. Cut-points will be determined based on previously defined and accepted standards. Descriptive statistics and simple scatter plots will be generated to review the tissue-based biomarker data. For continuous variables, the actual and % change in the level of each of the biomarkers from pre- to post-intervention will be explored using Wilcoxon signed rank tests, and paired sample t-tests. All categorical variables will be analyzed using chi-square tests or Fisher's exact test. For all translational endpoints, any notable statistical result will be viewed as an impetus for further study rather than as a definitive finding in and of itself.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 2.5 yearsLaboratory measures will be correlated with participant outcomes (i.e., polyp burden, adverse events) and with each other as well. Cut-points will be determined based on previously defined and accepted standards. Descriptive statistics and simple scatter plots will be generated to review the tissue-based biomarker data. For continuous variables, the actual and % change in the level of each of the biomarkers from pre- to post-intervention will be explored using Wilcoxon signed rank tests, and paired sample t-tests. All categorical variables will be analyzed using chi-square tests or Fisher's exact test. For all translational endpoints, any notable statistical result will be viewed as an impetus for further study rather than as a definitive finding in and of itself.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to 2.5 yearsLaboratory measures will be correlated with participant outcomes (i.e., polyp burden, adverse events) and with each other as well. Cut-points will be determined based on previously defined and accepted standards. Descriptive statistics and simple scatter plots will be generated to review the tissue-based biomarker data. For continuous variables, the actual and % change in the level of each of the biomarkers from pre- to post-intervention will be explored using Wilcoxon signed rank tests, and paired sample t-tests. All categorical variables will be analyzed using chi-square tests or Fisher's exact test. For all translational endpoints, any notable statistical result will be viewed as an impetus for further study rather than as a definitive finding in and of itself.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Erlotinib Hydrochloride)
Serious adverse events
| Measure |
Treatment (Erlotinib Hydrochloride)
n=46 participants at risk
Patients receive 350 mg erlotinib hydrochloride PO once weekly. Treatment continues for up to 6 months in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Gastrointestinal disorders
Small intestinal obstruction
|
2.2%
1/46 • Number of events 1 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.2%
1/46 • Number of events 1 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Reproductive system and breast disorders
Reproductive system and breast -Oth spec
|
2.2%
1/46 • Number of events 1 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
Other adverse events
| Measure |
Treatment (Erlotinib Hydrochloride)
n=46 participants at risk
Patients receive 350 mg erlotinib hydrochloride PO once weekly. Treatment continues for up to 6 months in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
4.3%
2/46 • Number of events 2 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Cardiac disorders
Palpitations
|
4.3%
2/46 • Number of events 3 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Ear and labyrinth disorders
Ear pain
|
2.2%
1/46 • Number of events 1 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Ear and labyrinth disorders
Middle ear inflammation
|
2.2%
1/46 • Number of events 1 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Ear and labyrinth disorders
Tinnitus
|
2.2%
1/46 • Number of events 1 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Eye disorders
Cataract
|
2.2%
1/46 • Number of events 1 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Eye disorders
Dry eye
|
4.3%
2/46 • Number of events 3 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Eye disorders
Eye disorders - Other, specify
|
2.2%
1/46 • Number of events 1 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Eye disorders
Keratitis
|
2.2%
1/46 • Number of events 1 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Eye disorders
Photophobia
|
2.2%
1/46 • Number of events 1 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.5%
3/46 • Number of events 6 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Gastrointestinal disorders
Constipation
|
2.2%
1/46 • Number of events 1 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Gastrointestinal disorders
Diarrhea
|
52.2%
24/46 • Number of events 47 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Gastrointestinal disorders
Dyspepsia
|
13.0%
6/46 • Number of events 6 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Gastrointestinal disorders
Dysphagia
|
2.2%
1/46 • Number of events 1 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Gastrointestinal disorders
Flatulence
|
6.5%
3/46 • Number of events 3 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Gastrointestinal disorders
Gastritis
|
4.3%
2/46 • Number of events 2 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
4.3%
2/46 • Number of events 2 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Oth spec
|
6.5%
3/46 • Number of events 3 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Gastrointestinal disorders
Lip pain
|
2.2%
1/46 • Number of events 1 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Gastrointestinal disorders
Mucositis oral
|
6.5%
3/46 • Number of events 5 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Gastrointestinal disorders
Nausea
|
34.8%
16/46 • Number of events 22 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Gastrointestinal disorders
Oral pain
|
4.3%
2/46 • Number of events 2 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Gastrointestinal disorders
Stomach pain
|
2.2%
1/46 • Number of events 1 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Gastrointestinal disorders
Toothache
|
2.2%
1/46 • Number of events 1 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Gastrointestinal disorders
Vomiting
|
15.2%
7/46 • Number of events 9 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
General disorders
Fatigue
|
26.1%
12/46 • Number of events 47 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
General disorders
Fever
|
2.2%
1/46 • Number of events 1 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
General disorders
Flu like symptoms
|
8.7%
4/46 • Number of events 4 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
General disorders
Gen disord and admin site conds-Oth spec
|
8.7%
4/46 • Number of events 4 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
General disorders
Malaise
|
8.7%
4/46 • Number of events 5 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
General disorders
Non-cardiac chest pain
|
4.3%
2/46 • Number of events 2 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
General disorders
Pain
|
4.3%
2/46 • Number of events 3 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Immune system disorders
Immune system disorders - Other, specify
|
4.3%
2/46 • Number of events 3 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Infections and infestations
Bronchial infection
|
4.3%
2/46 • Number of events 2 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Infections and infestations
Conjunctivitis
|
2.2%
1/46 • Number of events 2 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Infections and infestations
Enterocolitis infectious
|
4.3%
2/46 • Number of events 3 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Infections and infestations
Infections and infestations - Oth spec
|
6.5%
3/46 • Number of events 3 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Infections and infestations
Lip infection
|
2.2%
1/46 • Number of events 1 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Infections and infestations
Otitis externa
|
2.2%
1/46 • Number of events 1 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Infections and infestations
Pharyngitis
|
2.2%
1/46 • Number of events 1 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Infections and infestations
Rhinitis infective
|
2.2%
1/46 • Number of events 1 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Infections and infestations
Sinusitis
|
6.5%
3/46 • Number of events 3 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Infections and infestations
Tooth infection
|
2.2%
1/46 • Number of events 3 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Infections and infestations
Upper respiratory infection
|
2.2%
1/46 • Number of events 1 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Infections and infestations
Urinary tract infection
|
4.3%
2/46 • Number of events 3 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Infections and infestations
Vaginal infection
|
2.2%
1/46 • Number of events 1 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Injury, poisoning and procedural complications
Prolapse of intestinal stoma
|
2.2%
1/46 • Number of events 1 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Investigations
Alanine aminotransferase increased
|
2.2%
1/46 • Number of events 1 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Investigations
Creatinine increased
|
2.2%
1/46 • Number of events 1 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Investigations
Weight gain
|
2.2%
1/46 • Number of events 1 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Investigations
Weight loss
|
2.2%
1/46 • Number of events 1 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Metabolism and nutrition disorders
Anorexia
|
8.7%
4/46 • Number of events 7 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Metabolism and nutrition disorders
Dehydration
|
4.3%
2/46 • Number of events 2 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Metabolism and nutrition disorders
Metabolism, nutrition disord - Oth spec
|
2.2%
1/46 • Number of events 1 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.3%
2/46 • Number of events 3 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.3%
2/46 • Number of events 2 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
2.2%
1/46 • Number of events 1 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
4.3%
2/46 • Number of events 2 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal, conn tissue - Oth spec
|
6.5%
3/46 • Number of events 3 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.3%
2/46 • Number of events 5 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.2%
1/46 • Number of events 1 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.2%
1/46 • Number of events 1 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Nervous system disorders
Depressed level of consciousness
|
2.2%
1/46 • Number of events 1 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Nervous system disorders
Dizziness
|
15.2%
7/46 • Number of events 15 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Nervous system disorders
Dysgeusia
|
4.3%
2/46 • Number of events 2 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Nervous system disorders
Dysphasia
|
2.2%
1/46 • Number of events 1 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Nervous system disorders
Headache
|
26.1%
12/46 • Number of events 29 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Nervous system disorders
Paresthesia
|
2.2%
1/46 • Number of events 2 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Nervous system disorders
Syncope
|
2.2%
1/46 • Number of events 1 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Nervous system disorders
Vasovagal reaction
|
2.2%
1/46 • Number of events 1 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Psychiatric disorders
Anxiety
|
2.2%
1/46 • Number of events 1 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Psychiatric disorders
Insomnia
|
6.5%
3/46 • Number of events 3 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Psychiatric disorders
Irritability
|
2.2%
1/46 • Number of events 1 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
2.2%
1/46 • Number of events 1 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Renal and urinary disorders
Proteinuria
|
2.2%
1/46 • Number of events 1 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Renal and urinary disorders
Renal colic
|
2.2%
1/46 • Number of events 3 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Renal and urinary disorders
Urinary tract pain
|
2.2%
1/46 • Number of events 1 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Renal and urinary disorders
Urine discoloration
|
2.2%
1/46 • Number of events 1 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Reproductive system and breast disorders
Breast pain
|
2.2%
1/46 • Number of events 1 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Reproductive system and breast disorders
Dysmenorrhea
|
2.2%
1/46 • Number of events 1 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Reproductive system and breast disorders
Reproductive system and breast -Oth spec
|
2.2%
1/46 • Number of events 1 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.3%
2/46 • Number of events 2 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.5%
3/46 • Number of events 3 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.3%
2/46 • Number of events 4 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
4.3%
2/46 • Number of events 2 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
4.3%
2/46 • Number of events 2 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
2.2%
1/46 • Number of events 1 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic, mediastinal - Oth spec
|
8.7%
4/46 • Number of events 4 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
4.3%
2/46 • Number of events 2 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
10.9%
5/46 • Number of events 7 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.7%
4/46 • Number of events 6 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.2%
1/46 • Number of events 1 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
2.2%
1/46 • Number of events 1 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.7%
4/46 • Number of events 6 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
54.3%
25/46 • Number of events 54 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
6.5%
3/46 • Number of events 3 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
2.2%
1/46 • Number of events 1 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Skin and subcutaneous tissue disorders
Skin and subcut tissue disord - Oth spec
|
10.9%
5/46 • Number of events 8 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Vascular disorders
Hypertension
|
2.2%
1/46 • Number of events 4 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
|
Vascular disorders
Superficial thrombophlebitis
|
2.2%
1/46 • Number of events 1 • Adverse events were collected monthly for up to 7 months from registration.
Adverse events were collected monthly for up to 7 months from registration.
|
Additional Information
Paul J. Limburg, M.D., M.P.H.
Cancer Prevention Network (CPN) - Mayo Clinic College of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60