Trial Outcomes & Findings for Carboxyamidotriazole in Treating Patients With Stage III or Stage IV Non-small Cell Lung Cancer (NCT NCT00003869)
NCT ID: NCT00003869
Last Updated: 2014-05-20
Results Overview
OS was defined as the time from randomization to death of any cause. Participants who did not die or were lost to follow-up were censored at the time of last evaluation/follow-up date. Patients were followed for a maximum of 5 years from randomization. The median OS with 95%CI was estimated using the Kaplan Meier method.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
186 participants
Primary outcome timeframe
up to 5 years
Results posted on
2014-05-20
Participant Flow
Between April 1999 and January 2004, 194 patients were accrued to this study. This trial was closed to accrual prior to meeting the protocol projected 360 randomized patients due to slow accrual.
186 patients were randomized to either arm
Participant milestones
| Measure |
Carboxyamidotriazole
250 mg carboxyamidotriazole administered daily
|
Placebo
250 mg placebo administered daily
|
|---|---|---|
|
Overall Study
STARTED
|
94
|
92
|
|
Overall Study
COMPLETED
|
53
|
80
|
|
Overall Study
NOT COMPLETED
|
41
|
12
|
Reasons for withdrawal
| Measure |
Carboxyamidotriazole
250 mg carboxyamidotriazole administered daily
|
Placebo
250 mg placebo administered daily
|
|---|---|---|
|
Overall Study
Adverse Event
|
14
|
3
|
|
Overall Study
Withdrawal by Subject
|
21
|
3
|
|
Overall Study
Death
|
1
|
2
|
|
Overall Study
Alternative treatmnt, medical problems
|
5
|
4
|
Baseline Characteristics
Carboxyamidotriazole in Treating Patients With Stage III or Stage IV Non-small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Carboxyamidotriazole
n=94 Participants
250 mg carboxyamidotriazole administered daily
|
Placebo
n=92 Participants
250 mg placebo administered daily
|
Total
n=186 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<= 65 years
|
37 participants
n=5 Participants
|
50 participants
n=7 Participants
|
87 participants
n=5 Participants
|
|
Age, Customized
> 65 years
|
57 participants
n=5 Participants
|
42 participants
n=7 Participants
|
99 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 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
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
91 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
180 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
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Histology
Bronchoalveolar/large cell
|
6 participants
n=5 Participants
|
13 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Histology
NOS (not otherwise specified) NSCLC/not avaliable
|
16 participants
n=5 Participants
|
11 participants
n=7 Participants
|
27 participants
n=5 Participants
|
|
Histology
Adenocarcinoma
|
51 participants
n=5 Participants
|
55 participants
n=7 Participants
|
106 participants
n=5 Participants
|
|
Histology
Squamous
|
21 participants
n=5 Participants
|
13 participants
n=7 Participants
|
34 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group Performance Score
0 - Fully Active
|
37 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group Performance Score
1 - Ambulatory, restricted strenuous activity
|
47 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group Performance Score
2 - Ambulatory, unable to perform work activities
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Prior Response to Chemotherapy
Complete
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Prior Response to Chemotherapy
Partial
|
38 participants
n=5 Participants
|
45 participants
n=7 Participants
|
83 participants
n=5 Participants
|
|
Prior Response to Chemotherapy
Regression
|
9 participants
n=5 Participants
|
8 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Prior Response to Chemotherapy
Stable
|
42 participants
n=5 Participants
|
35 participants
n=7 Participants
|
77 participants
n=5 Participants
|
|
Smoking Status
Never
|
11 participants
n=5 Participants
|
10 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Smoking Status
Former (quit >= 6 months)
|
54 participants
n=5 Participants
|
57 participants
n=7 Participants
|
111 participants
n=5 Participants
|
|
Smoking Status
Current
|
20 participants
n=5 Participants
|
15 participants
n=7 Participants
|
35 participants
n=5 Participants
|
|
Smoking Status
Not Reported
|
9 participants
n=5 Participants
|
10 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
TNM Stage
IIIA/IIIB
|
22 participants
n=5 Participants
|
19 participants
n=7 Participants
|
41 participants
n=5 Participants
|
|
TNM Stage
IV
|
72 participants
n=5 Participants
|
73 participants
n=7 Participants
|
145 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 5 yearsPopulation: Overall survival was analyzed on all randomized participants on an intent to treat basis.
OS was defined as the time from randomization to death of any cause. Participants who did not die or were lost to follow-up were censored at the time of last evaluation/follow-up date. Patients were followed for a maximum of 5 years from randomization. The median OS with 95%CI was estimated using the Kaplan Meier method.
Outcome measures
| Measure |
Carboxyamidotriazole
n=94 Participants
250 mg carboxyamidotriazole administered daily
|
Placebo
n=92 Participants
250 mg placebo administered daily
|
|---|---|---|
|
Overall Survival (OS)
|
11.4 Months
Interval 9.2 to 13.9
|
10.5 Months
Interval 8.9 to 12.6
|
SECONDARY outcome
Timeframe: every cycle during treatmentPopulation: All treated participants; all participants who received study treatment.
Severe non-hematologic adverse events were defined as adverse events grade 3 or higher, regardless of attribution to study drug. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC version 2.0)
Outcome measures
| Measure |
Carboxyamidotriazole
n=90 Participants
250 mg carboxyamidotriazole administered daily
|
Placebo
n=92 Participants
250 mg placebo administered daily
|
|---|---|---|
|
Participants With Severe Non-hematologic Adverse Events
|
38 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: up to 5 yearsPopulation: TTP was analyzed on all randomized patients on an intent to treat basis.
TTP is defined as the time from randomization to first documented disease progression(PD). Patients who were lost to follow-up were censored at the time of last evaluation. For patients who died without clear documentation, PD was assumed at the midpoint of the time interval between last evaluation and death. Median TTP was estimated using the Kaplan Meier method. Measurable PD: ≥25% increase in the sum of the products of two greatest perpendicular diameters of all indicator lesions or appearance of new lesion(s). Evaluable PD: definite increase in tumor size or appearance of new lesion(s)
Outcome measures
| Measure |
Carboxyamidotriazole
n=94 Participants
250 mg carboxyamidotriazole administered daily
|
Placebo
n=92 Participants
250 mg placebo administered daily
|
|---|---|---|
|
Time to Disease Progression (TTP)
|
2.8 Months
Interval 2.1 to 3.8
|
2.4 Months
Interval 2.1 to 3.8
|
SECONDARY outcome
Timeframe: Baseline to week 8Population: Participants who completed the baseline and week 8 UNISCALE assessment are included in the analysis.
The UNISCALE was used to assess QOL. UNISCALE is a single item global measure of QOL. Participant were to complete the questionnaire at baseline and every 8 weeks, prior to assessment by the treating physician. A high score indicates a higher quality of life while a low score represents a lower quality of life. A 10 point or greater decline (from baseline to week 8) in UNISCALE QOL score was considered clinically significant.
Outcome measures
| Measure |
Carboxyamidotriazole
n=39 Participants
250 mg carboxyamidotriazole administered daily
|
Placebo
n=63 Participants
250 mg placebo administered daily
|
|---|---|---|
|
Clinically Significant (10-point) Decrease in UNISCALE Quality of Life (QOL)Assessment From Baseline to Week 8
|
28 participants
Interval 1.0 to 98.0
|
32 participants
Interval 0.7 to 100.0
|
SECONDARY outcome
Timeframe: Baseline to week 8Population: Participants who completed the baseline and week 8 FACT-L assessment are included in the analysis.
The FACT-L is a 36-item Likert instrument that combines frequency of symptomatic/QOL problems with perceived relative importance of each issue. It includes 4 constructs of well being: physical, social/family, emotional and functional, and a fifth construct, additional concerns, dealing solely with tumor related symptoms. Questionnaires were completed at baseline and 8 weeks. Questions within each construct were summated to obtain a construct score. A higher score relates to higher quality of life. A 10 point or greater decline (from baseline to week 8) was considered clinically significant.
Outcome measures
| Measure |
Carboxyamidotriazole
n=43 Participants
250 mg carboxyamidotriazole administered daily
|
Placebo
n=67 Participants
250 mg placebo administered daily
|
|---|---|---|
|
Clinically Significant (10-point) Decrease in Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) Quality of Life (QOL)Assessment From Baseline to Week 8
|
27 participants
Interval 40.2 to 93.1
|
33 participants
Interval 46.4 to 93.5
|
SECONDARY outcome
Timeframe: During Treatment (up to 5 years)Population: This data was not (and will never be) analyzed as it was not submitted consistently due to the trial design. (Patients were required to be SD or better to be randomized to carboxyamidotriazole or placebo.)
Confirmed response was defined as a complete response (CR) or partial response (PR) for patients with measurable disease or as a CR or regression (REGR) for patients with evaluable disease noted on 2 consecutive evaluations at least 4 weeks apart. * CR: total disappearance of all tumor; * PR: \>=50% reduction of the sum of the products of the two greatest perpendicular diameters of all indicator lesions; * REGR: Definite decrease in tumor size and no new lesion(s).
Outcome measures
Outcome data not reported
Adverse Events
Carboxyamidotriazole
Serious events: 9 serious events
Other events: 87 other events
Deaths: 0 deaths
Placebo
Serious events: 6 serious events
Other events: 84 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Carboxyamidotriazole
n=90 participants at risk
250 mg carboxyamidotriazole administered daily
|
Placebo
n=92 participants at risk
250 mg placebo administered daily
|
|---|---|---|
|
Cardiac disorders
Arrythmia
|
1.1%
1/90 • Number of events 1
|
0.00%
0/92
|
|
Cardiac disorders
Edema
|
1.1%
1/90 • Number of events 1
|
0.00%
0/92
|
|
Cardiac disorders
Ischemia/Infarction
|
0.00%
0/90
|
1.1%
1/92 • Number of events 1
|
|
Cardiac disorders
Supraventricular arrhythmias (SVT/atrial fibrillation/flutter)
|
1.1%
1/90 • Number of events 1
|
0.00%
0/92
|
|
Gastrointestinal disorders
Melena
|
0.00%
0/90
|
1.1%
1/92 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
1.1%
1/90 • Number of events 1
|
0.00%
0/92
|
|
Gastrointestinal disorders
Pain-Abdominal
|
0.00%
0/90
|
1.1%
1/92 • Number of events 1
|
|
Gastrointestinal disorders
Stomatitis
|
1.1%
1/90 • Number of events 1
|
0.00%
0/92
|
|
General disorders
Fatigue
|
1.1%
1/90 • Number of events 1
|
0.00%
0/92
|
|
General disorders
Fever-No ANC
|
1.1%
1/90 • Number of events 1
|
0.00%
0/92
|
|
Immune system disorders
Allergy
|
1.1%
1/90 • Number of events 1
|
0.00%
0/92
|
|
Infections and infestations
Infection without neutropenia
|
1.1%
1/90 • Number of events 1
|
0.00%
0/92
|
|
Metabolism and nutrition disorders
Dehydration
|
1.1%
1/90 • Number of events 1
|
0.00%
0/92
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.1%
1/90 • Number of events 1
|
0.00%
0/92
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.1%
1/90 • Number of events 1
|
0.00%
0/92
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.1%
1/90 • Number of events 1
|
0.00%
0/92
|
|
Nervous system disorders
Ataxia
|
1.1%
1/90 • Number of events 1
|
0.00%
0/92
|
|
Nervous system disorders
Dizziness
|
1.1%
1/90 • Number of events 1
|
1.1%
1/92 • Number of events 1
|
|
Nervous system disorders
Neuro-Sensory
|
1.1%
1/90 • Number of events 1
|
0.00%
0/92
|
|
Nervous system disorders
Seizure
|
0.00%
0/90
|
1.1%
1/92 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome (ARDS)
|
1.1%
1/90 • Number of events 1
|
0.00%
0/92
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.2%
2/90 • Number of events 2
|
1.1%
1/92 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Effusion-Pleural
|
1.1%
1/90 • Number of events 1
|
1.1%
1/92 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.1%
1/90 • Number of events 1
|
0.00%
0/92
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
1.1%
1/90 • Number of events 1
|
0.00%
0/92
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.1%
1/90 • Number of events 1
|
0.00%
0/92
|
|
Vascular disorders
Hypertension
|
1.1%
1/90 • Number of events 1
|
0.00%
0/92
|
|
Vascular disorders
Hypotension
|
1.1%
1/90 • Number of events 1
|
0.00%
0/92
|
|
Vascular disorders
Thrombosis
|
1.1%
1/90 • Number of events 1
|
0.00%
0/92
|
Other adverse events
| Measure |
Carboxyamidotriazole
n=90 participants at risk
250 mg carboxyamidotriazole administered daily
|
Placebo
n=92 participants at risk
250 mg placebo administered daily
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
48.9%
44/90 • Number of events 95
|
55.4%
51/92 • Number of events 151
|
|
Blood and lymphatic system disorders
Blood/Bone Marrow
|
0.00%
0/90
|
1.1%
1/92 • Number of events 1
|
|
Cardiac disorders
Arrhythmia-Nodal
|
1.1%
1/90 • Number of events 1
|
0.00%
0/92
|
|
Cardiac disorders
Arrythmia
|
0.00%
0/90
|
2.2%
2/92 • Number of events 2
|
|
Cardiac disorders
Cardiovascular
|
1.1%
1/90 • Number of events 1
|
0.00%
0/92
|
|
Cardiac disorders
Edema
|
4.4%
4/90 • Number of events 4
|
8.7%
8/92 • Number of events 29
|
|
Cardiac disorders
Palpitations
|
1.1%
1/90 • Number of events 1
|
0.00%
0/92
|
|
Cardiac disorders
Supraventricular arrhythmias (SVT/atrial fibrillation/flutter)
|
2.2%
2/90 • Number of events 2
|
2.2%
2/92 • Number of events 2
|
|
Ear and labyrinth disorders
Auditory
|
0.00%
0/90
|
3.3%
3/92 • Number of events 6
|
|
Ear and labyrinth disorders
Inner Ear
|
2.2%
2/90 • Number of events 6
|
1.1%
1/92 • Number of events 1
|
|
Eye disorders
Vision
|
1.1%
1/90 • Number of events 1
|
0.00%
0/92
|
|
Eye disorders
Vision-Blurred
|
6.7%
6/90 • Number of events 7
|
1.1%
1/92 • Number of events 1
|
|
Eye disorders
Vision-Double
|
1.1%
1/90 • Number of events 1
|
0.00%
0/92
|
|
Eye disorders
Vision-Photopsia
|
0.00%
0/90
|
1.1%
1/92 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
15.6%
14/90 • Number of events 17
|
8.7%
8/92 • Number of events 14
|
|
Gastrointestinal disorders
Diarrhea-BMT
|
1.1%
1/90 • Number of events 1
|
0.00%
0/92
|
|
Gastrointestinal disorders
Diarrhea-No Colostom
|
4.4%
4/90 • Number of events 4
|
4.3%
4/92 • Number of events 5
|
|
Gastrointestinal disorders
Dyspepsia
|
2.2%
2/90 • Number of events 2
|
1.1%
1/92 • Number of events 1
|
|
Gastrointestinal disorders
Dysphagia
|
1.1%
1/90 • Number of events 1
|
1.1%
1/92 • Number of events 1
|
|
Gastrointestinal disorders
Dysphagia-esophageal related to radiation
|
0.00%
0/90
|
1.1%
1/92 • Number of events 1
|
|
Gastrointestinal disorders
Flatulence
|
1.1%
1/90 • Number of events 1
|
2.2%
2/92 • Number of events 4
|
|
Gastrointestinal disorders
Gastrointestinal
|
0.00%
0/90
|
2.2%
2/92 • Number of events 4
|
|
Gastrointestinal disorders
Hematemesis
|
1.1%
1/90 • Number of events 1
|
0.00%
0/92
|
|
Gastrointestinal disorders
Mouth Dryness
|
1.1%
1/90 • Number of events 1
|
0.00%
0/92
|
|
Gastrointestinal disorders
Nausea
|
61.1%
55/90 • Number of events 102
|
30.4%
28/92 • Number of events 60
|
|
Gastrointestinal disorders
Pain-Abdominal
|
3.3%
3/90 • Number of events 3
|
4.3%
4/92 • Number of events 6
|
|
Gastrointestinal disorders
Stomatitis
|
1.1%
1/90 • Number of events 1
|
3.3%
3/92 • Number of events 6
|
|
Gastrointestinal disorders
Vomiting
|
32.2%
29/90 • Number of events 35
|
14.1%
13/92 • Number of events 17
|
|
General disorders
Fatigue
|
53.3%
48/90 • Number of events 90
|
29.3%
27/92 • Number of events 52
|
|
General disorders
Fever-No ANC
|
1.1%
1/90 • Number of events 1
|
1.1%
1/92 • Number of events 1
|
|
General disorders
Injection site reaction
|
0.00%
0/90
|
1.1%
1/92 • Number of events 1
|
|
General disorders
Pain
|
5.6%
5/90 • Number of events 7
|
8.7%
8/92 • Number of events 11
|
|
General disorders
Pain-Chest
|
3.3%
3/90 • Number of events 3
|
1.1%
1/92 • Number of events 1
|
|
General disorders
Rigors
|
1.1%
1/90 • Number of events 1
|
2.2%
2/92 • Number of events 2
|
|
Infections and infestations
Infection without neutropenia
|
4.4%
4/90 • Number of events 5
|
7.6%
7/92 • Number of events 7
|
|
Investigations
Alkaline phosphatase
|
0.00%
0/90
|
8.7%
8/92 • Number of events 10
|
|
Investigations
Bilirubin
|
2.2%
2/90 • Number of events 2
|
1.1%
1/92 • Number of events 1
|
|
Investigations
Creatinine
|
8.9%
8/90 • Number of events 16
|
5.4%
5/92 • Number of events 9
|
|
Investigations
Leukopenia
|
2.2%
2/90 • Number of events 2
|
5.4%
5/92 • Number of events 7
|
|
Investigations
Leukopenia-Peds
|
0.00%
0/90
|
1.1%
1/92 • Number of events 1
|
|
Investigations
Lymphopenia
|
3.3%
3/90 • Number of events 4
|
2.2%
2/92 • Number of events 5
|
|
Investigations
Metabolic/Lab
|
0.00%
0/90
|
1.1%
1/92 • Number of events 7
|
|
Investigations
Neutropenia
|
8.9%
8/90 • Number of events 9
|
7.6%
7/92 • Number of events 14
|
|
Investigations
Prothrombin Time
|
1.1%
1/90 • Number of events 1
|
0.00%
0/92
|
|
Investigations
SGOT (AST) (serum glutamic oxaloacetic transaminase)
|
3.3%
3/90 • Number of events 3
|
4.3%
4/92 • Number of events 6
|
|
Investigations
SGPT (ALT) (serum glutamic pyruvic transaminase)
|
2.2%
2/90 • Number of events 2
|
2.2%
2/92 • Number of events 2
|
|
Investigations
Thrombocytopenia
|
12.2%
11/90 • Number of events 12
|
10.9%
10/92 • Number of events 23
|
|
Investigations
Weight gain
|
0.00%
0/90
|
1.1%
1/92 • Number of events 1
|
|
Investigations
Weight loss
|
3.3%
3/90 • Number of events 4
|
4.3%
4/92 • Number of events 4
|
|
Metabolism and nutrition disorders
Anorexia
|
31.1%
28/90 • Number of events 44
|
13.0%
12/92 • Number of events 15
|
|
Metabolism and nutrition disorders
Bicarbonate
|
0.00%
0/90
|
1.1%
1/92 • Number of events 3
|
|
Metabolism and nutrition disorders
Dehydration
|
1.1%
1/90 • Number of events 1
|
0.00%
0/92
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/90
|
1.1%
1/92 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
4.4%
4/90 • Number of events 6
|
8.7%
8/92 • Number of events 18
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/90
|
2.2%
2/92 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
1.1%
1/90 • Number of events 1
|
4.3%
4/92 • Number of events 5
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/90
|
3.3%
3/92 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/90
|
2.2%
2/92 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypokalemia
|
1.1%
1/90 • Number of events 1
|
2.2%
2/92 • Number of events 4
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.2%
2/90 • Number of events 2
|
2.2%
2/92 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.8%
7/90 • Number of events 7
|
7.6%
7/92 • Number of events 13
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness
|
2.2%
2/90 • Number of events 2
|
0.00%
0/92
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
1.1%
1/90 • Number of events 1
|
0.00%
0/92
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.3%
3/90 • Number of events 3
|
10.9%
10/92 • Number of events 13
|
|
Musculoskeletal and connective tissue disorders
Pain-Bone
|
2.2%
2/90 • Number of events 2
|
6.5%
6/92 • Number of events 7
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pain-Tumor
|
0.00%
0/90
|
1.1%
1/92 • Number of events 1
|
|
Nervous system disorders
Ataxia
|
32.2%
29/90 • Number of events 43
|
16.3%
15/92 • Number of events 56
|
|
Nervous system disorders
CNS hemorrhage/bleeding
|
0.00%
0/90
|
1.1%
1/92 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
8.9%
8/90 • Number of events 9
|
6.5%
6/92 • Number of events 15
|
|
Nervous system disorders
Headache
|
4.4%
4/90 • Number of events 6
|
7.6%
7/92 • Number of events 8
|
|
Nervous system disorders
Learning Disorder
|
1.1%
1/90 • Number of events 1
|
0.00%
0/92
|
|
Nervous system disorders
Low Consciousness
|
2.2%
2/90 • Number of events 2
|
0.00%
0/92
|
|
Nervous system disorders
Memory Loss
|
2.2%
2/90 • Number of events 2
|
0.00%
0/92
|
|
Nervous system disorders
Neuralgia
|
2.2%
2/90 • Number of events 4
|
1.1%
1/92 • Number of events 2
|
|
Nervous system disorders
Neuro-Motor
|
4.4%
4/90 • Number of events 5
|
6.5%
6/92 • Number of events 10
|
|
Nervous system disorders
Neuro-Sensory
|
58.9%
53/90 • Number of events 125
|
44.6%
41/92 • Number of events 163
|
|
Nervous system disorders
Seizure
|
0.00%
0/90
|
2.2%
2/92 • Number of events 2
|
|
Nervous system disorders
Smell
|
1.1%
1/90 • Number of events 1
|
0.00%
0/92
|
|
Nervous system disorders
Taste
|
3.3%
3/90 • Number of events 4
|
3.3%
3/92 • Number of events 7
|
|
Nervous system disorders
Tremor
|
1.1%
1/90 • Number of events 1
|
1.1%
1/92 • Number of events 6
|
|
Nervous system disorders
Vertigo
|
0.00%
0/90
|
1.1%
1/92 • Number of events 4
|
|
Psychiatric disorders
Anxiety
|
2.2%
2/90 • Number of events 2
|
4.3%
4/92 • Number of events 19
|
|
Psychiatric disorders
Confusion
|
2.2%
2/90 • Number of events 2
|
1.1%
1/92 • Number of events 2
|
|
Psychiatric disorders
Depression
|
5.6%
5/90 • Number of events 5
|
4.3%
4/92 • Number of events 7
|
|
Psychiatric disorders
Insomnia
|
1.1%
1/90 • Number of events 1
|
1.1%
1/92 • Number of events 2
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/90
|
1.1%
1/92 • Number of events 2
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/90
|
1.1%
1/92 • Number of events 1
|
|
Renal and urinary disorders
Renal
|
0.00%
0/90
|
1.1%
1/92 • Number of events 3
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/90
|
1.1%
1/92 • Number of events 1
|
|
Reproductive system and breast disorders
Gynecomastia
|
0.00%
0/90
|
1.1%
1/92 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.8%
7/90 • Number of events 7
|
14.1%
13/92 • Number of events 22
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.7%
15/90 • Number of events 22
|
22.8%
21/92 • Number of events 49
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.1%
1/90 • Number of events 1
|
0.00%
0/92
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
2.2%
2/90 • Number of events 2
|
2.2%
2/92 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.1%
1/90 • Number of events 1
|
1.1%
1/92 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pain-Pleuritic
|
0.00%
0/90
|
3.3%
3/92 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/90
|
1.1%
1/92 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
1.1%
1/90 • Number of events 1
|
2.2%
2/92 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
0.00%
0/90
|
3.3%
3/92 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Voice Change
|
1.1%
1/90 • Number of events 1
|
1.1%
1/92 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
13.3%
12/90 • Number of events 16
|
16.3%
15/92 • Number of events 23
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/90
|
2.2%
2/92 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
1.1%
1/90 • Number of events 1
|
3.3%
3/92 • Number of events 10
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.3%
3/90 • Number of events 4
|
4.3%
4/92 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Sweating
|
1.1%
1/90 • Number of events 1
|
1.1%
1/92 • Number of events 1
|
|
Vascular disorders
Hot flashes
|
0.00%
0/90
|
2.2%
2/92 • Number of events 5
|
|
Vascular disorders
Hypertension
|
1.1%
1/90 • Number of events 1
|
1.1%
1/92 • Number of events 1
|
|
Vascular disorders
Hypotension
|
1.1%
1/90 • Number of events 1
|
0.00%
0/92
|
|
Vascular disorders
Phlebitis
|
0.00%
0/90
|
1.1%
1/92 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60