Trial Outcomes & Findings for Bevacizumab/Tarceva and Tarceva/Sulindac in Squamous Cell Carcinoma of the Head and Neck (NCT NCT00392665)
NCT ID: NCT00392665
Last Updated: 2017-04-13
Results Overview
The primary outcome will be measured by median progression-free survival (PFS), determined by the Kaplan-Meier method for both Arm A and Arm B. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
36 participants
Primary outcome timeframe
1 year
Results posted on
2017-04-13
Participant Flow
Participant milestones
| Measure |
Erlotinib + Bevacizumab
erlotinib plus bevacizumab
Bevacizumab: Given intravenously on day one of each 3 week cycle
erlotinib: Given orally once a day
|
Erlotinib + Sulindac
erlotinib plus sulindac
erlotinib: Given orally once a day
Sulindac: Given orally twice a day
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
18
|
|
Overall Study
COMPLETED
|
1
|
3
|
|
Overall Study
NOT COMPLETED
|
17
|
15
|
Reasons for withdrawal
| Measure |
Erlotinib + Bevacizumab
erlotinib plus bevacizumab
Bevacizumab: Given intravenously on day one of each 3 week cycle
erlotinib: Given orally once a day
|
Erlotinib + Sulindac
erlotinib plus sulindac
erlotinib: Given orally once a day
Sulindac: Given orally twice a day
|
|---|---|---|
|
Overall Study
Death
|
16
|
14
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
Bevacizumab/Tarceva and Tarceva/Sulindac in Squamous Cell Carcinoma of the Head and Neck
Baseline characteristics by cohort
| Measure |
Erlotinib + Bevacizumab
n=18 Participants
erlotinib plus bevacizumab
Bevacizumab: Given intravenously on day one of each 3 week cycle
erlotinib: Given orally once a day
|
Erlotinib + Sulindac
n=18 Participants
erlotinib plus sulindac
erlotinib: Given orally once a day
Sulindac: Given orally twice a day
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57 years
n=5 Participants
|
57 years
n=7 Participants
|
57 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
28 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
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearThe primary outcome will be measured by median progression-free survival (PFS), determined by the Kaplan-Meier method for both Arm A and Arm B. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Erlotinib + Bevacizumab
n=18 Participants
erlotinib plus bevacizumab
Bevacizumab: Given intravenously on day one of each 3 week cycle
erlotinib: Given orally once a day
|
Erlotinib + Sulindac
n=18 Participants
erlotinib plus sulindac
erlotinib: Given orally once a day
Sulindac: Given orally twice a day
|
|---|---|---|
|
Efficacy of Erlotinib Plus Bevacizumab (Arm A) or Erlotinib Plus Sulindac (Arm B) as Measured by Progression-free Survival.
|
9.38 months
Interval 4.28 to
the available data does not allow for calculation of an upper bound using the K-M method
|
7.01 months
Interval 2.24 to 11.38
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Two of eighteen patients in both arms had radiographic partial responses, for an overall response rate of 11% for both arms, (95% CI 1.2%, 34.7%). The identical results below are not typos or placeholder values.
Overall response rate (complete plus partial response=ORR), as determined by RECIST. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Erlotinib + Bevacizumab
n=18 Participants
erlotinib plus bevacizumab
Bevacizumab: Given intravenously on day one of each 3 week cycle
erlotinib: Given orally once a day
|
Erlotinib + Sulindac
n=18 Participants
erlotinib plus sulindac
erlotinib: Given orally once a day
Sulindac: Given orally twice a day
|
|---|---|---|
|
Overall Response Rate (ORR)
|
11.1 percentage of participants
Interval 1.2 to 34.7
|
11.1 percentage of participants
Interval 1.2 to 34.7
|
SECONDARY outcome
Timeframe: 2 yearsMedian overall survival (OS), determined by the Kaplan-Meier method.
Outcome measures
| Measure |
Erlotinib + Bevacizumab
n=18 Participants
erlotinib plus bevacizumab
Bevacizumab: Given intravenously on day one of each 3 week cycle
erlotinib: Given orally once a day
|
Erlotinib + Sulindac
n=18 Participants
erlotinib plus sulindac
erlotinib: Given orally once a day
Sulindac: Given orally twice a day
|
|---|---|---|
|
Duration of Overall Survival
|
9.38 months
Interval 4.28 to 14.54
|
8.82 months
Interval 2.24 to 14.14
|
SECONDARY outcome
Timeframe: 2 yearsToxicities by Grades 1 or 2 and Grades 3 or 4 in each arm. Grade 4 = life-threatening, Grade 3 = serious, Grade 2 = moderate, Grade 1 = Mild
Outcome measures
| Measure |
Erlotinib + Bevacizumab
n=18 Participants
erlotinib plus bevacizumab
Bevacizumab: Given intravenously on day one of each 3 week cycle
erlotinib: Given orally once a day
|
Erlotinib + Sulindac
n=18 Participants
erlotinib plus sulindac
erlotinib: Given orally once a day
Sulindac: Given orally twice a day
|
|---|---|---|
|
Number of Participants With Toxicities According to Severity
Fatigue · Grades 1 or 2
|
10 Participants
|
8 Participants
|
|
Number of Participants With Toxicities According to Severity
Fatigue · Grades 3 or 4
|
0 Participants
|
1 Participants
|
|
Number of Participants With Toxicities According to Severity
Fatigue · Did not have
|
8 Participants
|
9 Participants
|
|
Number of Participants With Toxicities According to Severity
Rash · Grades 1 or 2
|
14 Participants
|
15 Participants
|
|
Number of Participants With Toxicities According to Severity
Rash · Grades 3 or 4
|
4 Participants
|
1 Participants
|
|
Number of Participants With Toxicities According to Severity
Rash · Did not have
|
0 Participants
|
2 Participants
|
|
Number of Participants With Toxicities According to Severity
Diarrhea · Grades 1 or 2
|
8 Participants
|
9 Participants
|
|
Number of Participants With Toxicities According to Severity
Diarrhea · Grades 3 or 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Toxicities According to Severity
Diarrhea · Did not have
|
10 Participants
|
9 Participants
|
|
Number of Participants With Toxicities According to Severity
Hypertension · Grades 1 or 2
|
4 Participants
|
0 Participants
|
|
Number of Participants With Toxicities According to Severity
Hypertension · Grades 3 or 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Toxicities According to Severity
Hypertension · Did not have
|
14 Participants
|
18 Participants
|
|
Number of Participants With Toxicities According to Severity
Oral cavity pain · Grades 1 or 2
|
0 Participants
|
2 Participants
|
|
Number of Participants With Toxicities According to Severity
Oral cavity pain · Grades 3 or 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Toxicities According to Severity
Oral cavity pain · Did not have
|
18 Participants
|
16 Participants
|
|
Number of Participants With Toxicities According to Severity
Dry skin · Grades 1 or 2
|
0 Participants
|
2 Participants
|
|
Number of Participants With Toxicities According to Severity
Dry skin · Grades 3 or 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Toxicities According to Severity
Dry skin · Did not have
|
18 Participants
|
16 Participants
|
|
Number of Participants With Toxicities According to Severity
Hearing problems · Grades 1 or 2
|
0 Participants
|
2 Participants
|
|
Number of Participants With Toxicities According to Severity
Hearing problems · Grades 3 or 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Toxicities According to Severity
Hearing problems · Did not have
|
18 Participants
|
16 Participants
|
|
Number of Participants With Toxicities According to Severity
Dyspepsia · Grades 1 or 2
|
0 Participants
|
3 Participants
|
|
Number of Participants With Toxicities According to Severity
Dyspepsia · Grades 3 or 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Toxicities According to Severity
Dyspepsia · Did not have
|
18 Participants
|
15 Participants
|
|
Number of Participants With Toxicities According to Severity
Dry mouth · Grades 1 or 2
|
0 Participants
|
3 Participants
|
|
Number of Participants With Toxicities According to Severity
Dry mouth · Grades 3 or 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Toxicities According to Severity
Dry mouth · Did not have
|
18 Participants
|
15 Participants
|
|
Number of Participants With Toxicities According to Severity
Constipation · Grades 1 or 2
|
2 Participants
|
0 Participants
|
|
Number of Participants With Toxicities According to Severity
Constipation · Grades 3 or 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Toxicities According to Severity
Constipation · Did not have
|
16 Participants
|
18 Participants
|
|
Number of Participants With Toxicities According to Severity
Anorexia · Grades 1 or 2
|
6 Participants
|
0 Participants
|
|
Number of Participants With Toxicities According to Severity
Anorexia · Grades 3 or 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Toxicities According to Severity
Anorexia · Did not have
|
12 Participants
|
18 Participants
|
|
Number of Participants With Toxicities According to Severity
Dehydration · Grades 1 or 2
|
2 Participants
|
0 Participants
|
|
Number of Participants With Toxicities According to Severity
Dehydration · Grades 3 or 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Toxicities According to Severity
Dehydration · Did not have
|
16 Participants
|
18 Participants
|
|
Number of Participants With Toxicities According to Severity
Dyspnea · Grades 1 or 2
|
2 Participants
|
0 Participants
|
|
Number of Participants With Toxicities According to Severity
Dyspnea · Grades 3 or 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Toxicities According to Severity
Dyspnea · Did not have
|
16 Participants
|
18 Participants
|
|
Number of Participants With Toxicities According to Severity
Mucositis · Grades 1 or 2
|
4 Participants
|
2 Participants
|
|
Number of Participants With Toxicities According to Severity
Mucositis · Grades 3 or 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Toxicities According to Severity
Mucositis · Did not have
|
14 Participants
|
16 Participants
|
|
Number of Participants With Toxicities According to Severity
Neuropathy-sensory · Grades 1 or 2
|
0 Participants
|
2 Participants
|
|
Number of Participants With Toxicities According to Severity
Neuropathy-sensory · Grades 3 or 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Toxicities According to Severity
Neuropathy-sensory · Did not have
|
18 Participants
|
16 Participants
|
|
Number of Participants With Toxicities According to Severity
Hemmorrhage · Grades 1 or 2
|
8 Participants
|
0 Participants
|
|
Number of Participants With Toxicities According to Severity
Hemmorrhage · Grades 3 or 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Toxicities According to Severity
Hemmorrhage · Did not have
|
10 Participants
|
18 Participants
|
|
Number of Participants With Toxicities According to Severity
Nausea · Grades 1 or 2
|
4 Participants
|
2 Participants
|
|
Number of Participants With Toxicities According to Severity
Nausea · Grades 3 or 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Toxicities According to Severity
Nausea · Did not have
|
14 Participants
|
16 Participants
|
|
Number of Participants With Toxicities According to Severity
Vomiting · Grades 1 or 2
|
2 Participants
|
0 Participants
|
|
Number of Participants With Toxicities According to Severity
Vomiting · Grades 3 or 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Toxicities According to Severity
Vomiting · Did not have
|
16 Participants
|
18 Participants
|
|
Number of Participants With Toxicities According to Severity
Insomnia · Grades 1 or 2
|
2 Participants
|
0 Participants
|
|
Number of Participants With Toxicities According to Severity
Insomnia · Grades 3 or 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Toxicities According to Severity
Insomnia · Did not have
|
16 Participants
|
18 Participants
|
|
Number of Participants With Toxicities According to Severity
Pruritus · Grades 1 or 2
|
0 Participants
|
2 Participants
|
|
Number of Participants With Toxicities According to Severity
Pruritus · Grades 3 or 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Toxicities According to Severity
Pruritus · Did not have
|
18 Participants
|
16 Participants
|
|
Number of Participants With Toxicities According to Severity
Hypomagnesemia · Grades 1 or 2
|
2 Participants
|
2 Participants
|
|
Number of Participants With Toxicities According to Severity
Hypomagnesemia · Grades 3 or 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Toxicities According to Severity
Hypomagnesemia · Did not have
|
16 Participants
|
16 Participants
|
Adverse Events
Erlotinib + Bevacizumab
Serious events: 4 serious events
Other events: 18 other events
Deaths: 0 deaths
Erlotinib + Sulindac
Serious events: 5 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Erlotinib + Bevacizumab
n=18 participants at risk
erlotinib plus bevacizumab
Bevacizumab: Given intravenously on day one of each 3 week cycle
erlotinib: Given orally once a day
|
Erlotinib + Sulindac
n=18 participants at risk
erlotinib plus sulindac
erlotinib: Given orally once a day
Sulindac: Given orally twice a day
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
5.6%
1/18 • Number of events 1
|
5.6%
1/18 • Number of events 1
|
|
Gastrointestinal disorders
Dehydration
|
5.6%
1/18 • Number of events 1
|
5.6%
1/18 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
|
Vascular disorders
Vascular access-Thrombosis/embolism
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Nonneuropathic right-side muscle weak
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
Other adverse events
| Measure |
Erlotinib + Bevacizumab
n=18 participants at risk
erlotinib plus bevacizumab
Bevacizumab: Given intravenously on day one of each 3 week cycle
erlotinib: Given orally once a day
|
Erlotinib + Sulindac
n=18 participants at risk
erlotinib plus sulindac
erlotinib: Given orally once a day
Sulindac: Given orally twice a day
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
72.2%
13/18 • Number of events 24
|
61.1%
11/18 • Number of events 18
|
|
General disorders
Fatigue
|
72.2%
13/18 • Number of events 21
|
66.7%
12/18 • Number of events 19
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
38.9%
7/18 • Number of events 10
|
44.4%
8/18 • Number of events 10
|
|
Gastrointestinal disorders
Nausea
|
38.9%
7/18 • Number of events 9
|
27.8%
5/18 • Number of events 8
|
|
Gastrointestinal disorders
Dry mouth
|
38.9%
7/18 • Number of events 8
|
44.4%
8/18 • Number of events 14
|
|
Gastrointestinal disorders
Dysphagia
|
33.3%
6/18 • Number of events 7
|
27.8%
5/18 • Number of events 6
|
|
Gastrointestinal disorders
Constipation
|
27.8%
5/18 • Number of events 10
|
16.7%
3/18 • Number of events 3
|
|
General disorders
Oral cavity- pain
|
27.8%
5/18 • Number of events 9
|
11.1%
2/18 • Number of events 5
|
|
Cardiac disorders
Hypertension
|
27.8%
5/18 • Number of events 7
|
0.00%
0/18
|
|
General disorders
Head/headache
|
27.8%
5/18 • Number of events 5
|
5.6%
1/18 • Number of events 1
|
|
Gastrointestinal disorders
Anorexia
|
22.2%
4/18 • Number of events 6
|
11.1%
2/18 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
22.2%
4/18 • Number of events 5
|
16.7%
3/18 • Number of events 4
|
|
Blood and lymphatic system disorders
Hemorrhage-other
|
22.2%
4/18 • Number of events 5
|
5.6%
1/18 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
22.2%
4/18 • Number of events 5
|
16.7%
3/18 • Number of events 3
|
|
General disorders
Pain-other
|
22.2%
4/18 • Number of events 5
|
11.1%
2/18 • Number of events 2
|
|
Blood and lymphatic system disorders
Hemoglobin
|
22.2%
4/18 • Number of events 4
|
11.1%
2/18 • Number of events 4
|
|
Gastrointestinal disorders
Muco/stomatitis by exam- oral cavity
|
22.2%
4/18 • Number of events 4
|
5.6%
1/18 • Number of events 2
|
|
Blood and lymphatic system disorders
Nose- hemorrhage
|
22.2%
4/18 • Number of events 4
|
16.7%
3/18 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
16.7%
3/18 • Number of events 4
|
16.7%
3/18 • Number of events 5
|
|
Metabolism and nutrition disorders
Hyponatremia
|
16.7%
3/18 • Number of events 4
|
0.00%
0/18
|
|
Nervous system disorders
Neuropathy-sensory
|
16.7%
3/18 • Number of events 4
|
22.2%
4/18 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria
|
16.7%
3/18 • Number of events 4
|
5.6%
1/18 • Number of events 1
|
|
Gastrointestinal disorders
Dehydration
|
16.7%
3/18 • Number of events 3
|
5.6%
1/18 • Number of events 2
|
|
General disorders
Rigors/chills
|
16.7%
3/18 • Number of events 3
|
5.6%
1/18 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin-other
|
16.7%
3/18 • Number of events 3
|
5.6%
1/18 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
3/18 • Number of events 3
|
11.1%
2/18 • Number of events 3
|
|
General disorders
Throat/pharynx/larynx- pain
|
11.1%
2/18 • Number of events 4
|
0.00%
0/18
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
11.1%
2/18 • Number of events 3
|
16.7%
3/18 • Number of events 4
|
|
Gastrointestinal disorders
GI-other
|
11.1%
2/18 • Number of events 3
|
11.1%
2/18 • Number of events 3
|
|
Nervous system disorders
Anxiety
|
11.1%
2/18 • Number of events 2
|
5.6%
1/18 • Number of events 3
|
|
Metabolism and nutrition disorders
AST- SGOT
|
11.1%
2/18 • Number of events 2
|
5.6%
1/18 • Number of events 1
|
|
General disorders
Back- pain
|
11.1%
2/18 • Number of events 2
|
5.6%
1/18 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
11.1%
2/18 • Number of events 2
|
0.00%
0/18
|
|
Blood and lymphatic system disorders
Edema head and neck
|
11.1%
2/18 • Number of events 2
|
5.6%
1/18 • Number of events 1
|
|
Blood and lymphatic system disorders
Edema limb
|
11.1%
2/18 • Number of events 2
|
5.6%
1/18 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Extremity-lower (gait/walking)
|
11.1%
2/18 • Number of events 2
|
5.6%
1/18 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
11.1%
2/18 • Number of events 2
|
5.6%
1/18 • Number of events 2
|
|
Infections and infestations
Infection-other
|
11.1%
2/18 • Number of events 2
|
5.6%
1/18 • Number of events 1
|
|
General disorders
Insomnia
|
11.1%
2/18 • Number of events 2
|
5.6%
1/18 • Number of events 1
|
|
Eye disorders
Ocular-other
|
11.1%
2/18 • Number of events 2
|
5.6%
1/18 • Number of events 1
|
|
General disorders
Pain NOS
|
11.1%
2/18 • Number of events 2
|
27.8%
5/18 • Number of events 6
|
|
General disorders
Sweating
|
11.1%
2/18 • Number of events 2
|
0.00%
0/18
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
5.6%
1/18 • Number of events 2
|
16.7%
3/18 • Number of events 4
|
|
General disorders
Neck- pain
|
5.6%
1/18 • Number of events 2
|
11.1%
2/18 • Number of events 3
|
|
Gastrointestinal disorders
Salivary
|
5.6%
1/18 • Number of events 2
|
11.1%
2/18 • Number of events 2
|
|
General disorders
Abdomen- pain
|
5.6%
1/18 • Number of events 1
|
5.6%
1/18 • Number of events 1
|
|
Metabolism and nutrition disorders
ALT- SGPT
|
5.6%
1/18 • Number of events 1
|
5.6%
1/18 • Number of events 1
|
|
Metabolism and nutrition disorders
Bilirubin
|
5.6%
1/18 • Number of events 1
|
5.6%
1/18 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Chelitis
|
5.6%
1/18 • Number of events 1
|
5.6%
1/18 • Number of events 2
|
|
Metabolism and nutrition disorders
Creatinine
|
5.6%
1/18 • Number of events 1
|
5.6%
1/18 • Number of events 2
|
|
Nervous system disorders
Depression
|
5.6%
1/18 • Number of events 1
|
5.6%
1/18 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.6%
1/18 • Number of events 1
|
11.1%
2/18 • Number of events 2
|
|
Gastrointestinal disorders
Dyspepsia
|
5.6%
1/18 • Number of events 1
|
16.7%
3/18 • Number of events 4
|
|
Endocrine disorders
Hyopthyroidism
|
5.6%
1/18 • Number of events 1
|
5.6%
1/18 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
5.6%
1/18 • Number of events 1
|
5.6%
1/18 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
5.6%
1/18 • Number of events 1
|
11.1%
2/18 • Number of events 3
|
|
Renal and urinary disorders
Renal/GU-other
|
5.6%
1/18 • Number of events 1
|
5.6%
1/18 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Ulceration
|
5.6%
1/18 • Number of events 1
|
5.6%
1/18 • Number of events 1
|
|
Ear and labyrinth disorders
Hearing-other
|
0.00%
0/18
|
16.7%
3/18 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/soft tissue-other
|
0.00%
0/18
|
11.1%
2/18 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
0.00%
0/18
|
11.1%
2/18 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place