Trial Outcomes & Findings for Sorafenib Tosylate in Treating Patients With Desmoid Tumors or Aggressive Fibromatosis (NCT NCT02066181)
NCT ID: NCT02066181
Last Updated: 2023-06-07
Results Overview
PFS is defined as the time from randomization to the first occurrence of progression or death due to any cause. If no event exists, the PFS will be censored at the last disease assessment. Data following cross over will be analyzed and summarized separately from the data from the main course of treatment for these patients in an exploratory and hypothesis generating manner. Intention to treat principles will be used. Patient disease status was evaluated using RECSIT v1.1. Patients ending treatment for symptomatic deterioration without radiographic evidence of PD, were classified as having PD. Otherwise, patients not yet showing disease progression were classified as having no progression at the most recent disease assessment and in the following cases: crossing over to receive sorafenib, date of first non-protocol directed anti-cancer therapy, lost to follow-up, withdrawal of consent, and changing imaging methods from that which was used at study entry.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
87 participants
Primary outcome timeframe
Time from randomization to the first occurrence of progression or death due to any cause, assessed up to 3 years
Results posted on
2023-06-07
Participant Flow
Participant milestones
| Measure |
Arm I (Sorafenib Tosylate)
Patients receive sorafenib tosylate PO QD on days 1-28, 400 mg/day
|
Arm II (Placebo)
Patients receive placebo PO QD on days 1-28. Patients may crossover to Arm I upon disease progression.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
37
|
|
Overall Study
Crossed Over
|
0
|
28
|
|
Overall Study
COMPLETED
|
49
|
36
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Arm I (Sorafenib Tosylate)
Patients receive sorafenib tosylate PO QD on days 1-28, 400 mg/day
|
Arm II (Placebo)
Patients receive placebo PO QD on days 1-28. Patients may crossover to Arm I upon disease progression.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Sorafenib Tosylate in Treating Patients With Desmoid Tumors or Aggressive Fibromatosis
Baseline characteristics by cohort
| Measure |
Arm I (Sorafenib Tosylate)
n=50 Participants
Patients receive sorafenib tosylate PO QD on days 1-28.
|
Arm II (Placebo)
n=37 Participants
Patients receive placebo PO QD on days 1-28. Patients may crossover to Arm I upon disease progression.
|
Total
n=87 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37 years
n=5 Participants
|
37 years
n=7 Participants
|
37 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
27 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
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
41 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
70 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
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Time from randomization to the first occurrence of progression or death due to any cause, assessed up to 3 yearsPopulation: All patients that received treatment and were assessed for response.
PFS is defined as the time from randomization to the first occurrence of progression or death due to any cause. If no event exists, the PFS will be censored at the last disease assessment. Data following cross over will be analyzed and summarized separately from the data from the main course of treatment for these patients in an exploratory and hypothesis generating manner. Intention to treat principles will be used. Patient disease status was evaluated using RECSIT v1.1. Patients ending treatment for symptomatic deterioration without radiographic evidence of PD, were classified as having PD. Otherwise, patients not yet showing disease progression were classified as having no progression at the most recent disease assessment and in the following cases: crossing over to receive sorafenib, date of first non-protocol directed anti-cancer therapy, lost to follow-up, withdrawal of consent, and changing imaging methods from that which was used at study entry.
Outcome measures
| Measure |
Arm I (Sorafenib Tosylate)
n=49 Participants
Patients receive sorafenib tosylate PO QD on days 1-28, 400 mg/day.
|
Arm II (Placebo)
n=35 Participants
Patients receive placebo PO QD on days 1-28. Patients may crossover to Arm I upon disease progression.
|
Crossover Patients
After progression from Arm II(Placebo), patients receive sorafenib tosylate PO QD on days 1-28. These patients are per protocol, excluded/censored from secondary analysis and endpoints.
|
|---|---|---|---|
|
Progression-free Survival(PFS) Rate
Alive and Progression Free
|
42 Participants
|
13 Participants
|
—
|
|
Progression-free Survival(PFS) Rate
Progressed or Died
|
7 Participants
|
22 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Per protocol, crossover patients are excluded/censored from secondary analysis and endpoints.
INCLUDED IN THE ADVERSE EVENTS PORTION OF THE RESULTS SECTION. Frequency tables, summary statistics, and categorical analysis will be used to compare the distributions of toxicity for patients treated with sorafenib tosylate vs placebo. Data for patients who have crossed over or having received surgical or radiotherapy intervention will be summarized independently from their primary course of study treatment in an exploratory and hypothesis generating manner.
Outcome measures
| Measure |
Arm I (Sorafenib Tosylate)
n=49 Participants
Patients receive sorafenib tosylate PO QD on days 1-28, 400 mg/day.
|
Arm II (Placebo)
n=36 Participants
Patients receive placebo PO QD on days 1-28. Patients may crossover to Arm I upon disease progression.
|
Crossover Patients
After progression from Arm II(Placebo), patients receive sorafenib tosylate PO QD on days 1-28. These patients are per protocol, excluded/censored from secondary analysis and endpoints.
|
|---|---|---|---|
|
Incidence of Adverse Events, Using the Patient Reported Outcomes-Common Terminology Criteria in Adverse Events Version 4.0
|
49 Participants
|
36 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Time between randomization to the patient undergoing therapeutic surgical resection for this disease, assessed up to 3 yearsPopulation: Only the number of patients is presented due to the Protected Health Information as to the time to surgery for each of these individual patients. Crossover patients are per protocol, excluded/censored from secondary analysis and endpoints.
A log rank test will be used to compare the distributions of time to surgical intervention between the two arms using a 2-sided test and alpha=0.05 level of significance. Kaplan-Meier methodology will be used to estimate various time points and 95% confidence intervals will be calculated for these estimates. Surgery will be classified by outcome (eg, complete-macroscopic, complete-microscopic, or partial), type, location (eg, limb), thereafter analyzed by categorical analysis and descriptive statistics. Non-parametric methods will be used, as appropriate. Too few patients had surgery during treatment to perform analysis.
Outcome measures
| Measure |
Arm I (Sorafenib Tosylate)
n=49 Participants
Patients receive sorafenib tosylate PO QD on days 1-28, 400 mg/day.
|
Arm II (Placebo)
n=36 Participants
Patients receive placebo PO QD on days 1-28. Patients may crossover to Arm I upon disease progression.
|
Crossover Patients
After progression from Arm II(Placebo), patients receive sorafenib tosylate PO QD on days 1-28. These patients are per protocol, excluded/censored from secondary analysis and endpoints.
|
|---|---|---|---|
|
Time to Surgical Intervention During Treatment
Had surgery during treatment
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Time to Surgical Intervention During Treatment
Didn't have surgery during treatment
|
48 Participants
|
35 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Time between the date of randomization to until death, assessed up to 3 yearsPopulation: All patients that started treatment and were assessed for survival. Crossover patients were excluded/censored from secondary analysis and endpoints.
Kaplan-Meier methodology and log rank tests will be used to compare overall survival between the groups at various time points (eg, 1 year rate, 2 year rate, etc) and 95% confidence intervals will be calculated for these estimates. Data following crossover will be analyzed and summarized separately from the main course of treatment for these patients in an exploratory and hypothesis generating manner.
Outcome measures
| Measure |
Arm I (Sorafenib Tosylate)
n=49 Participants
Patients receive sorafenib tosylate PO QD on days 1-28, 400 mg/day.
|
Arm II (Placebo)
n=35 Participants
Patients receive placebo PO QD on days 1-28. Patients may crossover to Arm I upon disease progression.
|
Crossover Patients
After progression from Arm II(Placebo), patients receive sorafenib tosylate PO QD on days 1-28. These patients are per protocol, excluded/censored from secondary analysis and endpoints.
|
|---|---|---|---|
|
Overall Survival
Deaths
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Overall Survival
Alive
|
48 Participants
|
35 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: All patients that started treatment and were assessed for response.
Compared between the two treatment arms and using the Cochran-Mantel-Haenszel test. Complete Response (CR): All of the following must be true: a. Disappearance of all target lesions. b. Each target lymph node must have reduction in short axis to \<1.0 cm. Partial Response (PR): At least a 30% decrease in PBSD (sum of the longest diameter for all target lesions plus the sum of the short axis of all the target lymph nodes at current evaluation) taking as reference the BSD. Patients on Arm II (placebo) who crossover are censored for Best Objective Status at the time of crossover.
Outcome measures
| Measure |
Arm I (Sorafenib Tosylate)
n=49 Participants
Patients receive sorafenib tosylate PO QD on days 1-28, 400 mg/day.
|
Arm II (Placebo)
n=35 Participants
Patients receive placebo PO QD on days 1-28. Patients may crossover to Arm I upon disease progression.
|
Crossover Patients
After progression from Arm II(Placebo), patients receive sorafenib tosylate PO QD on days 1-28. These patients are per protocol, excluded/censored from secondary analysis and endpoints.
|
|---|---|---|---|
|
Best Objective Status Between the Two Treatment Arms According to Response Evaluation Criteria in Solid Tumors Version 1.1
CR
|
1 Participants
|
0 Participants
|
—
|
|
Best Objective Status Between the Two Treatment Arms According to Response Evaluation Criteria in Solid Tumors Version 1.1
PR
|
15 Participants
|
7 Participants
|
—
|
|
Best Objective Status Between the Two Treatment Arms According to Response Evaluation Criteria in Solid Tumors Version 1.1
Stable Diseaes or Progression
|
33 Participants
|
28 Participants
|
—
|
SECONDARY outcome
Timeframe: Time between first tumor response and progression, assessed up to 3 yearsPopulation: All patients that started treatment and were assessed for response.
Kaplan Meier methodology will be used to estimate the distribution of duration of response and the log-rank test will be used to test for a difference in duration of response between the two arms. Patients on Arm II (placebo) who crossover are censored for Duration of Response at the time of crossover.
Outcome measures
| Measure |
Arm I (Sorafenib Tosylate)
n=49 Participants
Patients receive sorafenib tosylate PO QD on days 1-28, 400 mg/day.
|
Arm II (Placebo)
n=35 Participants
Patients receive placebo PO QD on days 1-28. Patients may crossover to Arm I upon disease progression.
|
Crossover Patients
After progression from Arm II(Placebo), patients receive sorafenib tosylate PO QD on days 1-28. These patients are per protocol, excluded/censored from secondary analysis and endpoints.
|
|---|---|---|---|
|
Duration of Response
|
14.7 Months
Interval 8.7 to 18.6
|
11.0 Months
Interval 4.8 to 12.8
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to 3 yearsBest response (ordinal variable) and percent T2 signal change (continuous) will be correlated by Spearman?s rho.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to 3 yearsPercent T2 signal change (continuous) will be correlated by Spearman?s rho. The percent changes in MRI T2 signal from Week 8 to subsequent imaging will be compared between groups with \> 30% pain palliation using t-test or a nonparametric alternative (e.g., Wilcoxon rank-sum test).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Date of randomization to the earliest date that pain progression is observed, assessed up to 12 weeksDefined as a \>= 30% increase compared with baseline in the worst pain intensity score (BPI-SF ?worst pain? item) or either a \>= 30% increase in the average daily use of any type of opioid narcotic or the addition of a new opioid narcotic compared with baseline. Estimated for each arm using Kaplan-Meier estimates and will be compared between arms using a log- rank test. Descriptive statistics will include means, standard deviations, medians, and ranges for each continuous or ordinal scale/subscale/item by group at each time point.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Date of randomization to the earliest date that confirmed pain palliation is observed, assessed up to 12 weeksDefined at each time point as \>= 30% decrease from baseline in the worst pain intensity score (BPI-SF ?worst pain? item), with neither a concomitant \>= 30% increase in average daily use of any opioid narcotic, nor addition of any new opioid narcotic, relative to baseline. Estimated for each arm using Kaplan-Meier estimates and will be compared between arms using a log- rank test. Descriptive statistics will include means, standard deviations, medians, and ranges for each continuous or ordinal scale/subscale/item by group at each time point.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Time from the earliest date that confirmed pain palliation is observed to the earliest date that pain progression is observed, assessed up to 12 weeksDefined for all patients who experience confirmed pain palliation. Descriptive statistics will include means, standard deviations, medians, and ranges for each continuous or ordinal scale/subscale/item by group at each time point. Descriptive graphical techniques will include mean plots by group for each continuous or ordinal scale/subscale/item. Relative frequencies of responses for each ordinal item will also be generated at each time point by group.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to 12 weeksRate of pain palliation at week 8 confirmed as week 12 will be compared between arms using a two-sided alpha=0.05 chi-squared tests at the time of the final analysis. Descriptive statistics will include means, standard deviations, medians, and ranges for each continuous or ordinal scale/subscale/item by group at each time point. Descriptive graphical techniques will include mean plots by group for each continuous or ordinal scale/subscale/item. Relative frequencies of responses for each ordinal item will also be generated at each time point by group.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 3 yearsAssociations among the possible predictors of response to sorafenib and CTNNBI mutations will be examined using Fisher?s exact test, Kruskal-Wallis test, or Spearman?s correlation coefficient as appropriate. Strata will be compared by using the log-rank test. Multivariate models will be constructed by introducing all variables aforementioned simultaneously into the model and then eliminating variables using the backward selection method. P values will be two-tailed and considered significant at alpha 0.05.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to day 8Permutation testing of the same selection will be performed 1000 times and the sample group labels switched around in each permutation. A two-sided t-test will be used to identify differentially expressed genes on log transformed data and those with a twofold change. False discovery rate will be assessed by permutation testing (n = 1000) of the sample group labels. Enrichment will be assessed by one-sided Fisher?s exact test with estimated false discovery rate.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to day 8The analysis will identify over- and under-expressed genes in pre-treatment and day 8 biopsies as compared to all control samples.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to day 8Compared by paired t-test. Quantitative changes will be correlated with disease status at 1 year by Fishers exact test.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to day 8Compared by paired t-test. Quantitative changes will be correlated with disease status at 1 year by Fishers exact test.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to day 8Compared by paired t-test. Quantitative changes will be correlated with disease status at 1 year by Fishers exact test.
Outcome measures
Outcome data not reported
Adverse Events
Arm I (Sorafenib Tosylate)
Serious events: 11 serious events
Other events: 49 other events
Deaths: 1 deaths
Arm II (Placebo)
Serious events: 6 serious events
Other events: 34 other events
Deaths: 0 deaths
Crossover Group
Serious events: 5 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I (Sorafenib Tosylate)
n=49 participants at risk
Patients receive sorafenib tosylate PO QD on days 1-28.
|
Arm II (Placebo)
n=36 participants at risk
Patients receive placebo PO QD on days 1-28. Patients may crossover to Arm I upon disease progression.
|
Crossover Group
n=28 participants at risk
Upon disease progression, patients treated with placebo will be allowed to crossover to the open label sorafenib arm.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
2.0%
1/49 • Number of events 1 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
2.0%
1/49 • Number of events 1 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
Cardiac disorders
Chest pain - cardiac
|
2.0%
1/49 • Number of events 1 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
Cardiac disorders
Heart failure
|
2.0%
1/49 • Number of events 1 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
Cardiac disorders
Palpitations
|
2.0%
1/49 • Number of events 1 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/49 • Up to 3 years
|
2.8%
1/36 • Number of events 1 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
4.1%
2/49 • Number of events 5 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
Gastrointestinal disorders
Gastric perforation
|
2.0%
1/49 • Number of events 2 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
Gastrointestinal disorders
Malabsorption
|
0.00%
0/49 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
3.6%
1/28 • Number of events 4 • Up to 3 years
|
|
Gastrointestinal disorders
Nausea
|
2.0%
1/49 • Number of events 2 • Up to 3 years
|
2.8%
1/36 • Number of events 1 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
Gastrointestinal disorders
Pancreatitis
|
2.0%
1/49 • Number of events 1 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/49 • Up to 3 years
|
5.6%
2/36 • Number of events 2 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/49 • Up to 3 years
|
2.8%
1/36 • Number of events 1 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
General disorders
Fatigue
|
4.1%
2/49 • Number of events 2 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
General disorders
Fever
|
0.00%
0/49 • Up to 3 years
|
2.8%
1/36 • Number of events 1 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
0.00%
0/49 • Up to 3 years
|
2.8%
1/36 • Number of events 1 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
Infections and infestations
Appendicitis
|
0.00%
0/49 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
3.6%
1/28 • Number of events 1 • Up to 3 years
|
|
Infections and infestations
Sepsis
|
0.00%
0/49 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
3.6%
1/28 • Number of events 1 • Up to 3 years
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
0.00%
0/49 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
3.6%
1/28 • Number of events 1 • Up to 3 years
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/49 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
3.6%
1/28 • Number of events 1 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
2.0%
1/49 • Number of events 1 • Up to 3 years
|
2.8%
1/36 • Number of events 1 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.0%
1/49 • Number of events 1 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/49 • Up to 3 years
|
2.8%
1/36 • Number of events 2 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy, puerperium and perinatal conditions - Other, specify
|
2.0%
1/49 • Number of events 1 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
Pregnancy, puerperium and perinatal conditions
Unintended pregnancy
|
2.0%
1/49 • Number of events 4 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
Renal and urinary disorders
Acute kidney injury
|
2.0%
1/49 • Number of events 1 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.0%
1/49 • Number of events 1 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
4.1%
2/49 • Number of events 8 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
2.0%
1/49 • Number of events 1 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
Vascular disorders
Hypertension
|
2.0%
1/49 • Number of events 1 • Up to 3 years
|
2.8%
1/36 • Number of events 1 • Up to 3 years
|
3.6%
1/28 • Number of events 1 • Up to 3 years
|
Other adverse events
| Measure |
Arm I (Sorafenib Tosylate)
n=49 participants at risk
Patients receive sorafenib tosylate PO QD on days 1-28.
|
Arm II (Placebo)
n=36 participants at risk
Patients receive placebo PO QD on days 1-28. Patients may crossover to Arm I upon disease progression.
|
Crossover Group
n=28 participants at risk
Upon disease progression, patients treated with placebo will be allowed to crossover to the open label sorafenib arm.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
18.4%
9/49 • Number of events 27 • Up to 3 years
|
11.1%
4/36 • Number of events 18 • Up to 3 years
|
17.9%
5/28 • Number of events 18 • Up to 3 years
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
2.0%
1/49 • Number of events 3 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
7.1%
2/28 • Number of events 14 • Up to 3 years
|
|
Blood and lymphatic system disorders
Leukocytosis
|
2.0%
1/49 • Number of events 1 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
2.0%
1/49 • Number of events 22 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
Cardiac disorders
Chest pain - cardiac
|
0.00%
0/49 • Up to 3 years
|
2.8%
1/36 • Number of events 1 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
Cardiac disorders
Myocardial infarction
|
2.0%
1/49 • Number of events 1 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/49 • Up to 3 years
|
5.6%
2/36 • Number of events 5 • Up to 3 years
|
3.6%
1/28 • Number of events 2 • Up to 3 years
|
|
Ear and labyrinth disorders
Tinnitus
|
4.1%
2/49 • Number of events 3 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
Ear and labyrinth disorders
Vertigo
|
2.0%
1/49 • Number of events 1 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
Endocrine disorders
Endocrine disorders - Other, specify
|
0.00%
0/49 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
7.1%
2/28 • Number of events 6 • Up to 3 years
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/49 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
7.1%
2/28 • Number of events 3 • Up to 3 years
|
|
Endocrine disorders
Hypothyroidism
|
2.0%
1/49 • Number of events 4 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
3.6%
1/28 • Number of events 2 • Up to 3 years
|
|
Eye disorders
Blurred vision
|
2.0%
1/49 • Number of events 6 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
Eye disorders
Dry eye
|
2.0%
1/49 • Number of events 2 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
3.6%
1/28 • Number of events 2 • Up to 3 years
|
|
Eye disorders
Eye disorders - Other, specify
|
6.1%
3/49 • Number of events 18 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
Gastrointestinal disorders
Abdominal pain
|
32.7%
16/49 • Number of events 136 • Up to 3 years
|
36.1%
13/36 • Number of events 144 • Up to 3 years
|
57.1%
16/28 • Number of events 132 • Up to 3 years
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/49 • Up to 3 years
|
2.8%
1/36 • Number of events 2 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
Gastrointestinal disorders
Anal hemorrhage
|
2.0%
1/49 • Number of events 10 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/49 • Up to 3 years
|
5.6%
2/36 • Number of events 15 • Up to 3 years
|
3.6%
1/28 • Number of events 5 • Up to 3 years
|
|
Gastrointestinal disorders
Constipation
|
22.4%
11/49 • Number of events 67 • Up to 3 years
|
11.1%
4/36 • Number of events 12 • Up to 3 years
|
7.1%
2/28 • Number of events 15 • Up to 3 years
|
|
Gastrointestinal disorders
Dental caries
|
4.1%
2/49 • Number of events 5 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
55.1%
27/49 • Number of events 254 • Up to 3 years
|
33.3%
12/36 • Number of events 115 • Up to 3 years
|
60.7%
17/28 • Number of events 172 • Up to 3 years
|
|
Gastrointestinal disorders
Dry mouth
|
4.1%
2/49 • Number of events 2 • Up to 3 years
|
5.6%
2/36 • Number of events 25 • Up to 3 years
|
7.1%
2/28 • Number of events 15 • Up to 3 years
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/49 • Up to 3 years
|
2.8%
1/36 • Number of events 1 • Up to 3 years
|
7.1%
2/28 • Number of events 6 • Up to 3 years
|
|
Gastrointestinal disorders
Dysphagia
|
2.0%
1/49 • Number of events 2 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
Gastrointestinal disorders
Esophageal pain
|
2.0%
1/49 • Number of events 1 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/49 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
3.6%
1/28 • Number of events 1 • Up to 3 years
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/49 • Up to 3 years
|
2.8%
1/36 • Number of events 1 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/49 • Up to 3 years
|
2.8%
1/36 • Number of events 1 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
2.0%
1/49 • Number of events 2 • Up to 3 years
|
2.8%
1/36 • Number of events 4 • Up to 3 years
|
7.1%
2/28 • Number of events 6 • Up to 3 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
4.1%
2/49 • Number of events 22 • Up to 3 years
|
8.3%
3/36 • Number of events 7 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
Gastrointestinal disorders
Hemorrhoids
|
2.0%
1/49 • Number of events 2 • Up to 3 years
|
2.8%
1/36 • Number of events 1 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
Gastrointestinal disorders
Malabsorption
|
0.00%
0/49 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
3.6%
1/28 • Number of events 4 • Up to 3 years
|
|
Gastrointestinal disorders
Mucositis oral
|
22.4%
11/49 • Number of events 70 • Up to 3 years
|
16.7%
6/36 • Number of events 31 • Up to 3 years
|
28.6%
8/28 • Number of events 45 • Up to 3 years
|
|
Gastrointestinal disorders
Nausea
|
51.0%
25/49 • Number of events 196 • Up to 3 years
|
41.7%
15/36 • Number of events 160 • Up to 3 years
|
60.7%
17/28 • Number of events 133 • Up to 3 years
|
|
Gastrointestinal disorders
Oral dysesthesia
|
2.0%
1/49 • Number of events 40 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
3.6%
1/28 • Number of events 33 • Up to 3 years
|
|
Gastrointestinal disorders
Oral hemorrhage
|
0.00%
0/49 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
7.1%
2/28 • Number of events 38 • Up to 3 years
|
|
Gastrointestinal disorders
Oral pain
|
2.0%
1/49 • Number of events 1 • Up to 3 years
|
2.8%
1/36 • Number of events 2 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
Gastrointestinal disorders
Periodontal disease
|
2.0%
1/49 • Number of events 4 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/49 • Up to 3 years
|
2.8%
1/36 • Number of events 1 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
Gastrointestinal disorders
Vomiting
|
26.5%
13/49 • Number of events 42 • Up to 3 years
|
22.2%
8/36 • Number of events 26 • Up to 3 years
|
28.6%
8/28 • Number of events 22 • Up to 3 years
|
|
General disorders
Chills
|
2.0%
1/49 • Number of events 1 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
14.3%
4/28 • Number of events 11 • Up to 3 years
|
|
General disorders
Edema limbs
|
0.00%
0/49 • Up to 3 years
|
2.8%
1/36 • Number of events 2 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
General disorders
Fatigue
|
73.5%
36/49 • Number of events 461 • Up to 3 years
|
63.9%
23/36 • Number of events 206 • Up to 3 years
|
75.0%
21/28 • Number of events 241 • Up to 3 years
|
|
General disorders
Fever
|
2.0%
1/49 • Number of events 1 • Up to 3 years
|
2.8%
1/36 • Number of events 1 • Up to 3 years
|
3.6%
1/28 • Number of events 1 • Up to 3 years
|
|
General disorders
Flu like symptoms
|
2.0%
1/49 • Number of events 5 • Up to 3 years
|
2.8%
1/36 • Number of events 1 • Up to 3 years
|
3.6%
1/28 • Number of events 2 • Up to 3 years
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
6.1%
3/49 • Number of events 23 • Up to 3 years
|
5.6%
2/36 • Number of events 5 • Up to 3 years
|
7.1%
2/28 • Number of events 2 • Up to 3 years
|
|
General disorders
Malaise
|
0.00%
0/49 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
3.6%
1/28 • Number of events 1 • Up to 3 years
|
|
General disorders
Non-cardiac chest pain
|
4.1%
2/49 • Number of events 2 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
3.6%
1/28 • Number of events 1 • Up to 3 years
|
|
General disorders
Pain
|
6.1%
3/49 • Number of events 5 • Up to 3 years
|
8.3%
3/36 • Number of events 17 • Up to 3 years
|
3.6%
1/28 • Number of events 10 • Up to 3 years
|
|
Infections and infestations
Infections and infestations - Other, specify
|
4.1%
2/49 • Number of events 2 • Up to 3 years
|
2.8%
1/36 • Number of events 1 • Up to 3 years
|
3.6%
1/28 • Number of events 2 • Up to 3 years
|
|
Infections and infestations
Nail infection
|
2.0%
1/49 • Number of events 8 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
Infections and infestations
Papulopustular rash
|
61.2%
30/49 • Number of events 142 • Up to 3 years
|
19.4%
7/36 • Number of events 29 • Up to 3 years
|
35.7%
10/28 • Number of events 44 • Up to 3 years
|
|
Infections and infestations
Sinusitis
|
2.0%
1/49 • Number of events 1 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
Infections and infestations
Skin infection
|
6.1%
3/49 • Number of events 4 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
7.1%
2/28 • Number of events 8 • Up to 3 years
|
|
Infections and infestations
Urinary tract infection
|
2.0%
1/49 • Number of events 1 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
Injury, poisoning and procedural complications
Bruising
|
2.0%
1/49 • Number of events 18 • Up to 3 years
|
8.3%
3/36 • Number of events 4 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
2.0%
1/49 • Number of events 1 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
Injury, poisoning and procedural complications
Fall
|
2.0%
1/49 • Number of events 1 • Up to 3 years
|
2.8%
1/36 • Number of events 3 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
0.00%
0/49 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
3.6%
1/28 • Number of events 2 • Up to 3 years
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/49 • Up to 3 years
|
2.8%
1/36 • Number of events 1 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/49 • Up to 3 years
|
2.8%
1/36 • Number of events 1 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
Investigations
Alanine aminotransferase increased
|
18.4%
9/49 • Number of events 44 • Up to 3 years
|
11.1%
4/36 • Number of events 25 • Up to 3 years
|
14.3%
4/28 • Number of events 25 • Up to 3 years
|
|
Investigations
Alkaline phosphatase increased
|
6.1%
3/49 • Number of events 9 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
3.6%
1/28 • Number of events 2 • Up to 3 years
|
|
Investigations
Aspartate aminotransferase increased
|
12.2%
6/49 • Number of events 11 • Up to 3 years
|
8.3%
3/36 • Number of events 16 • Up to 3 years
|
25.0%
7/28 • Number of events 37 • Up to 3 years
|
|
Investigations
Blood bilirubin increased
|
10.2%
5/49 • Number of events 63 • Up to 3 years
|
11.1%
4/36 • Number of events 10 • Up to 3 years
|
3.6%
1/28 • Number of events 5 • Up to 3 years
|
|
Investigations
Cholesterol high
|
2.0%
1/49 • Number of events 8 • Up to 3 years
|
5.6%
2/36 • Number of events 2 • Up to 3 years
|
3.6%
1/28 • Number of events 1 • Up to 3 years
|
|
Investigations
Creatinine increased
|
2.0%
1/49 • Number of events 2 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
3.6%
1/28 • Number of events 3 • Up to 3 years
|
|
Investigations
Hemoglobin increased
|
4.1%
2/49 • Number of events 4 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
3.6%
1/28 • Number of events 1 • Up to 3 years
|
|
Investigations
Investigations - Other, specify
|
10.2%
5/49 • Number of events 29 • Up to 3 years
|
11.1%
4/36 • Number of events 8 • Up to 3 years
|
7.1%
2/28 • Number of events 20 • Up to 3 years
|
|
Investigations
Lipase increased
|
0.00%
0/49 • Up to 3 years
|
2.8%
1/36 • Number of events 2 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
Investigations
Lymphocyte count decreased
|
4.1%
2/49 • Number of events 4 • Up to 3 years
|
8.3%
3/36 • Number of events 10 • Up to 3 years
|
7.1%
2/28 • Number of events 6 • Up to 3 years
|
|
Investigations
Neutrophil count decreased
|
10.2%
5/49 • Number of events 24 • Up to 3 years
|
5.6%
2/36 • Number of events 6 • Up to 3 years
|
14.3%
4/28 • Number of events 11 • Up to 3 years
|
|
Investigations
Platelet count decreased
|
16.3%
8/49 • Number of events 51 • Up to 3 years
|
2.8%
1/36 • Number of events 1 • Up to 3 years
|
10.7%
3/28 • Number of events 19 • Up to 3 years
|
|
Investigations
Weight gain
|
0.00%
0/49 • Up to 3 years
|
2.8%
1/36 • Number of events 13 • Up to 3 years
|
3.6%
1/28 • Number of events 11 • Up to 3 years
|
|
Investigations
Weight loss
|
4.1%
2/49 • Number of events 46 • Up to 3 years
|
5.6%
2/36 • Number of events 14 • Up to 3 years
|
14.3%
4/28 • Number of events 61 • Up to 3 years
|
|
Investigations
White blood cell decreased
|
6.1%
3/49 • Number of events 27 • Up to 3 years
|
16.7%
6/36 • Number of events 38 • Up to 3 years
|
17.9%
5/28 • Number of events 51 • Up to 3 years
|
|
Metabolism and nutrition disorders
Anorexia
|
30.6%
15/49 • Number of events 161 • Up to 3 years
|
25.0%
9/36 • Number of events 60 • Up to 3 years
|
32.1%
9/28 • Number of events 91 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
6.1%
3/49 • Number of events 4 • Up to 3 years
|
2.8%
1/36 • Number of events 4 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
14.3%
7/49 • Number of events 29 • Up to 3 years
|
8.3%
3/36 • Number of events 5 • Up to 3 years
|
10.7%
3/28 • Number of events 9 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
6.1%
3/49 • Number of events 8 • Up to 3 years
|
2.8%
1/36 • Number of events 1 • Up to 3 years
|
10.7%
3/28 • Number of events 6 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hypernatremia
|
4.1%
2/49 • Number of events 3 • Up to 3 years
|
5.6%
2/36 • Number of events 3 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
2.0%
1/49 • Number of events 7 • Up to 3 years
|
2.8%
1/36 • Number of events 2 • Up to 3 years
|
3.6%
1/28 • Number of events 1 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
4.1%
2/49 • Number of events 4 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
6.1%
3/49 • Number of events 3 • Up to 3 years
|
5.6%
2/36 • Number of events 4 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
4.1%
2/49 • Number of events 6 • Up to 3 years
|
5.6%
2/36 • Number of events 14 • Up to 3 years
|
3.6%
1/28 • Number of events 2 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
6.1%
3/49 • Number of events 14 • Up to 3 years
|
2.8%
1/36 • Number of events 2 • Up to 3 years
|
3.6%
1/28 • Number of events 1 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/49 • Up to 3 years
|
2.8%
1/36 • Number of events 4 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/49 • Up to 3 years
|
2.8%
1/36 • Number of events 7 • Up to 3 years
|
7.1%
2/28 • Number of events 2 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
2.0%
1/49 • Number of events 1 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
3.6%
1/28 • Number of events 1 • Up to 3 years
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
4.1%
2/49 • Number of events 2 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
34.7%
17/49 • Number of events 173 • Up to 3 years
|
25.0%
9/36 • Number of events 46 • Up to 3 years
|
50.0%
14/28 • Number of events 79 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.2%
4/49 • Number of events 23 • Up to 3 years
|
5.6%
2/36 • Number of events 19 • Up to 3 years
|
3.6%
1/28 • Number of events 11 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
2.0%
1/49 • Number of events 1 • Up to 3 years
|
2.8%
1/36 • Number of events 1 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/49 • Up to 3 years
|
5.6%
2/36 • Number of events 3 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/49 • Up to 3 years
|
2.8%
1/36 • Number of events 7 • Up to 3 years
|
3.6%
1/28 • Number of events 1 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
0.00%
0/49 • Up to 3 years
|
2.8%
1/36 • Number of events 1 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
6.1%
3/49 • Number of events 32 • Up to 3 years
|
11.1%
4/36 • Number of events 14 • Up to 3 years
|
14.3%
4/28 • Number of events 14 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
38.8%
19/49 • Number of events 206 • Up to 3 years
|
33.3%
12/36 • Number of events 54 • Up to 3 years
|
42.9%
12/28 • Number of events 79 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.0%
1/49 • Number of events 19 • Up to 3 years
|
5.6%
2/36 • Number of events 3 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.2%
4/49 • Number of events 9 • Up to 3 years
|
8.3%
3/36 • Number of events 4 • Up to 3 years
|
3.6%
1/28 • Number of events 7 • Up to 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
2.0%
1/49 • Number of events 10 • Up to 3 years
|
2.8%
1/36 • Number of events 1 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/49 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
3.6%
1/28 • Number of events 1 • Up to 3 years
|
|
Nervous system disorders
Concentration impairment
|
2.0%
1/49 • Number of events 2 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
Nervous system disorders
Dizziness
|
6.1%
3/49 • Number of events 10 • Up to 3 years
|
5.6%
2/36 • Number of events 2 • Up to 3 years
|
3.6%
1/28 • Number of events 12 • Up to 3 years
|
|
Nervous system disorders
Dysgeusia
|
4.1%
2/49 • Number of events 2 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
Nervous system disorders
Headache
|
8.2%
4/49 • Number of events 5 • Up to 3 years
|
19.4%
7/36 • Number of events 41 • Up to 3 years
|
28.6%
8/28 • Number of events 58 • Up to 3 years
|
|
Nervous system disorders
Memory impairment
|
2.0%
1/49 • Number of events 2 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
8.2%
4/49 • Number of events 16 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/49 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
7.1%
2/28 • Number of events 6 • Up to 3 years
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/49 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
3.6%
1/28 • Number of events 1 • Up to 3 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
12.2%
6/49 • Number of events 35 • Up to 3 years
|
2.8%
1/36 • Number of events 2 • Up to 3 years
|
7.1%
2/28 • Number of events 14 • Up to 3 years
|
|
Nervous system disorders
Phantom pain
|
0.00%
0/49 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
3.6%
1/28 • Number of events 12 • Up to 3 years
|
|
Nervous system disorders
Spasticity
|
2.0%
1/49 • Number of events 7 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
Psychiatric disorders
Anxiety
|
4.1%
2/49 • Number of events 9 • Up to 3 years
|
2.8%
1/36 • Number of events 7 • Up to 3 years
|
7.1%
2/28 • Number of events 9 • Up to 3 years
|
|
Psychiatric disorders
Depression
|
2.0%
1/49 • Number of events 1 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
3.6%
1/28 • Number of events 1 • Up to 3 years
|
|
Psychiatric disorders
Insomnia
|
2.0%
1/49 • Number of events 2 • Up to 3 years
|
2.8%
1/36 • Number of events 3 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
Psychiatric disorders
Personality change
|
0.00%
0/49 • Up to 3 years
|
2.8%
1/36 • Number of events 1 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
2.0%
1/49 • Number of events 1 • Up to 3 years
|
2.8%
1/36 • Number of events 20 • Up to 3 years
|
3.6%
1/28 • Number of events 11 • Up to 3 years
|
|
Renal and urinary disorders
Hematuria
|
2.0%
1/49 • Number of events 1 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
Renal and urinary disorders
Urinary tract obstruction
|
2.0%
1/49 • Number of events 2 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
3.6%
1/28 • Number of events 1 • Up to 3 years
|
|
Renal and urinary disorders
Urinary urgency
|
0.00%
0/49 • Up to 3 years
|
2.8%
1/36 • Number of events 1 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
Reproductive system and breast disorders
Dysmenorrhea
|
2.0%
1/49 • Number of events 9 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
Reproductive system and breast disorders
Irregular menstruation
|
4.1%
2/49 • Number of events 20 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
3.6%
1/28 • Number of events 8 • Up to 3 years
|
|
Reproductive system and breast disorders
Menorrhagia
|
4.1%
2/49 • Number of events 7 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
3.6%
1/28 • Number of events 1 • Up to 3 years
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other, specify
|
0.00%
0/49 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
3.6%
1/28 • Number of events 4 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
2.0%
1/49 • Number of events 13 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
3.6%
1/28 • Number of events 5 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.1%
3/49 • Number of events 6 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
3.6%
1/28 • Number of events 4 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.0%
1/49 • Number of events 2 • Up to 3 years
|
2.8%
1/36 • Number of events 8 • Up to 3 years
|
3.6%
1/28 • Number of events 11 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/49 • Up to 3 years
|
2.8%
1/36 • Number of events 1 • Up to 3 years
|
3.6%
1/28 • Number of events 2 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/49 • Up to 3 years
|
2.8%
1/36 • Number of events 1 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
2.0%
1/49 • Number of events 5 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
6.1%
3/49 • Number of events 4 • Up to 3 years
|
2.8%
1/36 • Number of events 2 • Up to 3 years
|
3.6%
1/28 • Number of events 2 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
2.0%
1/49 • Number of events 1 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
4.1%
2/49 • Number of events 4 • Up to 3 years
|
2.8%
1/36 • Number of events 2 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
36.7%
18/49 • Number of events 172 • Up to 3 years
|
11.1%
4/36 • Number of events 17 • Up to 3 years
|
25.0%
7/28 • Number of events 82 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
10.2%
5/49 • Number of events 61 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
10.7%
3/28 • Number of events 10 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
0.00%
0/49 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
3.6%
1/28 • Number of events 3 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
71.4%
35/49 • Number of events 327 • Up to 3 years
|
25.0%
9/36 • Number of events 36 • Up to 3 years
|
67.9%
19/28 • Number of events 213 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
0.00%
0/49 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
3.6%
1/28 • Number of events 23 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.3%
7/49 • Number of events 30 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
14.3%
4/28 • Number of events 7 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
12.2%
6/49 • Number of events 75 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
7.1%
2/28 • Number of events 15 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
14.3%
7/49 • Number of events 86 • Up to 3 years
|
2.8%
1/36 • Number of events 3 • Up to 3 years
|
21.4%
6/28 • Number of events 39 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
4.1%
2/49 • Number of events 2 • Up to 3 years
|
2.8%
1/36 • Number of events 22 • Up to 3 years
|
7.1%
2/28 • Number of events 9 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
14.3%
7/49 • Number of events 33 • Up to 3 years
|
13.9%
5/36 • Number of events 22 • Up to 3 years
|
7.1%
2/28 • Number of events 17 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Skin atrophy
|
0.00%
0/49 • Up to 3 years
|
2.8%
1/36 • Number of events 1 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/49 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
3.6%
1/28 • Number of events 1 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
2.0%
1/49 • Number of events 3 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
7.1%
2/28 • Number of events 57 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
2.0%
1/49 • Number of events 1 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify
|
0.00%
0/49 • Up to 3 years
|
2.8%
1/36 • Number of events 1 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
Vascular disorders
Flushing
|
4.1%
2/49 • Number of events 2 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
3.6%
1/28 • Number of events 2 • Up to 3 years
|
|
Vascular disorders
Hot flashes
|
0.00%
0/49 • Up to 3 years
|
2.8%
1/36 • Number of events 1 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
|
Vascular disorders
Hypertension
|
63.3%
31/49 • Number of events 412 • Up to 3 years
|
38.9%
14/36 • Number of events 83 • Up to 3 years
|
57.1%
16/28 • Number of events 229 • Up to 3 years
|
|
Vascular disorders
Lymphedema
|
2.0%
1/49 • Number of events 21 • Up to 3 years
|
0.00%
0/36 • Up to 3 years
|
0.00%
0/28 • Up to 3 years
|
Additional Information
Mrinal Murugesan Gounder M.D.
Memorial Sloan-Kettering Cancer Center
Phone: 646-888-4167
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60