Trial Outcomes & Findings for Bortezomib and Temozolomide in Treating Patients With Advanced Refractory Solid Tumors or Melanoma (NCT NCT00512798)
NCT ID: NCT00512798
Last Updated: 2012-10-02
Results Overview
The optimal biologic dose (OBD) defined as the dose that achieves the greatest degree of inhibition of NF-κB activation in peripheral blood mononuclear cells when co-administered with Temozolomide
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
47 participants
Primary outcome timeframe
up to 42 days
Results posted on
2012-10-02
Participant Flow
This study remained open to accrual from 6/3/03 to 3/11/08.
19 participants were enrolled to the phase I portion of this trial and 28 were enrolled to the phase II portion of this trial. There were also 3 participants that were consented to take part in this trial, but were determined to be ineligible.
Participant milestones
| Measure |
Phase I
PS-341 will be administered intravenously at 1.0 mg/m2 of body weight beginning on days 1, 4, 8, and 11 of every 21 days. If toxicity occurs, dose will be lowered to 0.7 mg/m2. Dose can be raised to a maximum of 1.5 mg/m2. Temozolomide will be orally administered daily at 50 mg/m2 of body weight beginning on day 8 for 6 weeks of every 9-week cycle, followed by a 3-week rest. Minimum dose is 50 mg/m2 and maximum dose is 75 mg/m2.
|
Phase II
PS-341 and Temozolomide will be administered in the same manner as in Phase I at doses as determined by the Phase I portion of the trial.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
28
|
|
Overall Study
COMPLETED
|
0
|
1
|
|
Overall Study
NOT COMPLETED
|
19
|
27
|
Reasons for withdrawal
| Measure |
Phase I
PS-341 will be administered intravenously at 1.0 mg/m2 of body weight beginning on days 1, 4, 8, and 11 of every 21 days. If toxicity occurs, dose will be lowered to 0.7 mg/m2. Dose can be raised to a maximum of 1.5 mg/m2. Temozolomide will be orally administered daily at 50 mg/m2 of body weight beginning on day 8 for 6 weeks of every 9-week cycle, followed by a 3-week rest. Minimum dose is 50 mg/m2 and maximum dose is 75 mg/m2.
|
Phase II
PS-341 and Temozolomide will be administered in the same manner as in Phase I at doses as determined by the Phase I portion of the trial.
|
|---|---|---|
|
Overall Study
Death
|
0
|
3
|
|
Overall Study
Adverse Event
|
2
|
4
|
|
Overall Study
Progression of disease
|
14
|
20
|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
Baseline Characteristics
Bortezomib and Temozolomide in Treating Patients With Advanced Refractory Solid Tumors or Melanoma
Baseline characteristics by cohort
| Measure |
Phase I
n=19 Participants
|
Phase II
n=28 Participants
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
33 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
|
Age Continuous
|
58 years
n=93 Participants
|
58 years
n=4 Participants
|
58 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
34 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=93 Participants
|
28 participants
n=4 Participants
|
47 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: up to 42 daysPopulation: All Phase I patients who received the study drugs
The optimal biologic dose (OBD) defined as the dose that achieves the greatest degree of inhibition of NF-κB activation in peripheral blood mononuclear cells when co-administered with Temozolomide
Outcome measures
| Measure |
Phase I
n=19 Participants
Patients with advanced, incurable melanoma who are chemotherapy-naive or patients who had undergone prior therapy with Dacarbazine or Temozolomide with treatment failure.
|
|---|---|
|
Optimal Doses of Temozolomide and Bortezomib (Phase I)
bortezomib
|
1.3 mg/m2
|
|
Optimal Doses of Temozolomide and Bortezomib (Phase I)
temozolomide
|
75 mg/m2
|
PRIMARY outcome
Timeframe: every 9 weeks to a maximum of 54 weeksPopulation: Patients who were available to measure response to the study drugs.
Per RECIST criteria v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) \> 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) \> 20% increase in the sum of the LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions. Patients with CR + PR + SD
Outcome measures
| Measure |
Phase I
n=28 Participants
Patients with advanced, incurable melanoma who are chemotherapy-naive or patients who had undergone prior therapy with Dacarbazine or Temozolomide with treatment failure.
|
|---|---|
|
Number of Patients With Clinical Anti-tumor Activity Phase II)
Complete Response
|
0 participants
|
|
Number of Patients With Clinical Anti-tumor Activity Phase II)
Partial Response
|
1 participants
|
|
Number of Patients With Clinical Anti-tumor Activity Phase II)
Stable Disease
|
5 participants
|
|
Number of Patients With Clinical Anti-tumor Activity Phase II)
Progressive Disease
|
22 participants
|
SECONDARY outcome
Timeframe: at baseline, on day 8 and on day 29Population: Phase I patients for whom blood was taken at baseline,on day 8 and on day 29 of each cycle. There was no correlation of change in NF-kB activation with changes in tumor tissue
Patient with a minimum of 50% reduction from baseline on day 8 or day 29 in NF-kB, measured by picograms/milliliter in peripheral mononuclear blood cells
Outcome measures
| Measure |
Phase I
n=19 Participants
Patients with advanced, incurable melanoma who are chemotherapy-naive or patients who had undergone prior therapy with Dacarbazine or Temozolomide with treatment failure.
|
|---|---|
|
Patients With Inhibition in NF-kB Activation (Phase I)
|
0 participants
|
SECONDARY outcome
Timeframe: every 9 weeks up to a maximum of 54 weeksPopulation: Patients who received treatment and who were available for measurement of lesions.
Per RECIST criteria v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) \> 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) \> 20% increase in the sum of the LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions
Outcome measures
| Measure |
Phase I
n=19 Participants
Patients with advanced, incurable melanoma who are chemotherapy-naive or patients who had undergone prior therapy with Dacarbazine or Temozolomide with treatment failure.
|
|---|---|
|
Patients With Clinical Anti-tumor Activity (Phase I)
Complete Response
|
0 participants
|
|
Patients With Clinical Anti-tumor Activity (Phase I)
Partial Response
|
4 participants
|
|
Patients With Clinical Anti-tumor Activity (Phase I)
Stable Disease
|
1 participants
|
|
Patients With Clinical Anti-tumor Activity (Phase I)
Progressive Disease
|
14 participants
|
SECONDARY outcome
Timeframe: at baseline, on day 8 and on day 29Population: Patients with advanced, incurable melanoma who are chemotherapy-naive and patients who had undergone prior chemotherapy with either Dacarbazine or Temozolomide with treatment failure. No degree of inhibition of NF-kB was observed. Phase II not completed due to lack of efficacy.
Patient with a minimum of 50% reduction from baseline on day 8 or day 29 in NF-kB, measured by picograms/milliliter in peripheral mononuclear blood cells
Outcome measures
| Measure |
Phase I
n=28 Participants
Patients with advanced, incurable melanoma who are chemotherapy-naive or patients who had undergone prior therapy with Dacarbazine or Temozolomide with treatment failure.
|
|---|---|
|
Patients With Inhibition of NF-kB (Phase II)
|
0 participants
|
Adverse Events
Phase I
Serious events: 6 serious events
Other events: 19 other events
Deaths: 0 deaths
Phase II
Serious events: 4 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase I
n=19 participants at risk
|
Phase II
n=28 participants at risk
|
|---|---|---|
|
Investigations
Platelet count decreased
|
0.00%
0/19
|
3.6%
1/28 • Number of events 1
|
|
Cardiac disorders
Ischemia/infarction
|
0.00%
0/19
|
3.6%
1/28 • Number of events 1
|
|
Cardiac disorders
Edema
|
0.00%
0/19
|
3.6%
1/28 • Number of events 1
|
|
Vascular disorders
Thrombosis/embolism
|
0.00%
0/19
|
3.6%
1/28 • Number of events 1
|
|
General disorders
Fatigue
|
5.3%
1/19 • Number of events 1
|
3.6%
1/28 • Number of events 1
|
|
Infections and infestations
Wound - infection
|
5.3%
1/19 • Number of events 1
|
3.6%
1/28 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
5.3%
1/19 • Number of events 1
|
7.1%
2/28 • Number of events 2
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/19
|
3.6%
1/28 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
0.00%
0/19
|
3.6%
1/28 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
10.5%
2/19 • Number of events 2
|
3.6%
1/28 • Number of events 1
|
|
Gastrointestinal disorders
Death
|
0.00%
0/19
|
7.1%
2/28 • Number of events 2
|
|
Investigations
hemoglobin
|
5.3%
1/19 • Number of events 1
|
0.00%
0/28
|
|
Cardiac disorders
conduction abnormality/atrioventricular heart block
|
5.3%
1/19 • Number of events 1
|
0.00%
0/28
|
|
Gastrointestinal disorders
vomiting
|
5.3%
1/19 • Number of events 1
|
3.6%
1/28 • Number of events 1
|
|
Metabolism and nutrition disorders
hyperkalemia
|
5.3%
1/19 • Number of events 1
|
0.00%
0/28
|
|
Nervous system disorders
depressed level of consciousness
|
5.3%
1/19 • Number of events 1
|
0.00%
0/28
|
|
Respiratory, thoracic and mediastinal disorders
pleuritic pain
|
5.3%
1/19 • Number of events 1
|
0.00%
0/28
|
|
Musculoskeletal and connective tissue disorders
right groin pain
|
5.3%
1/19 • Number of events 1
|
0.00%
0/28
|
|
General disorders
fever
|
0.00%
0/19
|
3.6%
1/28 • Number of events 1
|
|
Investigations
creatinine
|
5.3%
1/19 • Number of events 1
|
0.00%
0/28
|
Other adverse events
| Measure |
Phase I
n=19 participants at risk
|
Phase II
n=28 participants at risk
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
10.5%
2/19 • Number of events 11
|
3.6%
1/28 • Number of events 12
|
|
Gastrointestinal disorders
abdominal pain or cramping
|
42.1%
8/19 • Number of events 57
|
17.9%
5/28 • Number of events 11
|
|
Investigations
alkaline phosphatase
|
15.8%
3/19 • Number of events 22
|
3.6%
1/28 • Number of events 4
|
|
Immune system disorders
allergic reaction/hypersensivity
|
5.3%
1/19 • Number of events 1
|
0.00%
0/28
|
|
Metabolism and nutrition disorders
anorexia
|
73.7%
14/19 • Number of events 159
|
42.9%
12/28 • Number of events 83
|
|
Respiratory, thoracic and mediastinal disorders
apnea
|
5.3%
1/19 • Number of events 1
|
0.00%
0/28
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
26.3%
5/19 • Number of events 52
|
17.9%
5/28 • Number of events 33
|
|
Musculoskeletal and connective tissue disorders
arthritis
|
5.3%
1/19 • Number of events 11
|
3.6%
1/28 • Number of events 4
|
|
Nervous system disorders
Ataxia
|
5.3%
1/19 • Number of events 4
|
0.00%
0/28
|
|
Musculoskeletal and connective tissue disorders
bone pain
|
15.8%
3/19 • Number of events 10
|
3.6%
1/28 • Number of events 3
|
|
Cardiac disorders
Chest pain
|
10.5%
2/19 • Number of events 12
|
0.00%
0/28
|
|
Cardiac disorders
circulatory or cardiac other
|
5.3%
1/19 • Number of events 1
|
0.00%
0/28
|
|
Eye disorders
conjunctivitis
|
5.3%
1/19 • Number of events 2
|
0.00%
0/28
|
|
Gastrointestinal disorders
constipation
|
68.4%
13/19 • Number of events 103
|
32.1%
9/28 • Number of events 48
|
|
General disorders
Constitutional symptoms Other
|
21.1%
4/19 • Number of events 10
|
3.6%
1/28 • Number of events 7
|
|
Investigations
Creatinine
|
5.3%
1/19 • Number of events 1
|
3.6%
1/28 • Number of events 4
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/19
|
7.1%
2/28 • Number of events 4
|
|
Gastrointestinal disorders
Diarrhea patients without colostomy
|
36.8%
7/19 • Number of events 25
|
39.3%
11/28 • Number of events 31
|
|
Nervous system disorders
Dizziness/lightheadedness
|
31.6%
6/19 • Number of events 33
|
10.7%
3/28 • Number of events 15
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.3%
1/19 • Number of events 6
|
0.00%
0/28
|
|
Gastrointestinal disorders
Dyspepsia/heartburn
|
15.8%
3/19 • Number of events 53
|
28.6%
8/28 • Number of events 38
|
|
Gastrointestinal disorders
Dysphagia, esophagitis, odynophagia
|
10.5%
2/19 • Number of events 3
|
3.6%
1/28 • Number of events 14
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
31.6%
6/19 • Number of events 71
|
32.1%
9/28 • Number of events 27
|
|
General disorders
Edema
|
26.3%
5/19 • Number of events 63
|
28.6%
8/28 • Number of events 124
|
|
Endocrine disorders
Endocrine other
|
0.00%
0/19
|
7.1%
2/28 • Number of events 14
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.3%
1/19 • Number of events 2
|
0.00%
0/28
|
|
General disorders
Fatigue
|
94.7%
18/19 • Number of events 241
|
85.7%
24/28 • Number of events 234
|
|
General disorders
Fever
|
26.3%
5/19 • Number of events 14
|
17.9%
5/28 • Number of events 30
|
|
Gastrointestinal disorders
GI other
|
31.6%
6/19 • Number of events 66
|
7.1%
2/28 • Number of events 18
|
|
Nervous system disorders
Headache
|
47.4%
9/19 • Number of events 44
|
14.3%
4/28 • Number of events 7
|
|
Investigations
Hemoglobin
|
100.0%
19/19 • Number of events 150
|
78.6%
22/28 • Number of events 199
|
|
Blood and lymphatic system disorders
Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia
|
5.3%
1/19 • Number of events 1
|
0.00%
0/28
|
|
Blood and lymphatic system disorders
Hemorrhage/bleeding without grade 3 or 4 thrombocytopenia
|
5.3%
1/19 • Number of events 2
|
0.00%
0/28
|
|
Hepatobiliary disorders
Hepatic pain
|
5.3%
1/19 • Number of events 1
|
0.00%
0/28
|
|
Investigations
Hypercholesterolemia
|
0.00%
0/19
|
14.3%
4/28 • Number of events 30
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
10.5%
2/19 • Number of events 5
|
42.9%
12/28 • Number of events 76
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
5.3%
1/19 • Number of events 1
|
0.00%
0/28
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
5.3%
1/19 • Number of events 1
|
0.00%
0/28
|
|
Vascular disorders
Hypertension
|
10.5%
2/19 • Number of events 15
|
32.1%
9/28 • Number of events 76
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/19
|
14.3%
4/28 • Number of events 24
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/19
|
10.7%
3/28 • Number of events 27
|
|
Metabolism and nutrition disorders
hypocalcemia
|
5.3%
1/19 • Number of events 3
|
0.00%
0/28
|
|
Metabolism and nutrition disorders
hypokalemia
|
5.3%
1/19 • Number of events 1
|
17.9%
5/28 • Number of events 16
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
5.3%
1/19 • Number of events 5
|
10.7%
3/28 • Number of events 7
|
|
Metabolism and nutrition disorders
Hyponatremia
|
21.1%
4/19 • Number of events 18
|
25.0%
7/28 • Number of events 37
|
|
Vascular disorders
Hypotension
|
21.1%
4/19 • Number of events 9
|
0.00%
0/28
|
|
Infections and infestations
Infection without neutropenia
|
5.3%
1/19 • Number of events 2
|
14.3%
4/28 • Number of events 9
|
|
Psychiatric disorders
Insomnia
|
15.8%
3/19 • Number of events 28
|
25.0%
7/28 • Number of events 34
|
|
Musculoskeletal and connective tissue disorders
Joint, muscle, bone Other
|
15.8%
3/19 • Number of events 34
|
0.00%
0/28
|
|
Blood and lymphatic system disorders
Leukocytes
|
21.1%
4/19 • Number of events 15
|
7.1%
2/28 • Number of events 6
|
|
Nervous system disorders
Memory loss
|
0.00%
0/19
|
7.1%
2/28 • Number of events 18
|
|
Psychiatric disorders
Mood alteration - depression
|
15.8%
3/19 • Number of events 34
|
25.0%
7/28 • Number of events 45
|
|
Psychiatric disorders
Mood alteration - anxiety, agitation
|
5.3%
1/19 • Number of events 1
|
10.7%
3/28 • Number of events 26
|
|
Gastrointestinal disorders
Mucositis
|
5.3%
1/19 • Number of events 8
|
7.1%
2/28 • Number of events 4
|
|
Metabolism and nutrition disorders
Muscle weakness
|
0.00%
0/19
|
10.7%
3/28 • Number of events 28
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
31.6%
6/19 • Number of events 61
|
10.7%
3/28 • Number of events 25
|
|
Gastrointestinal disorders
Nausea
|
68.4%
13/19 • Number of events 123
|
82.1%
23/28 • Number of events 146
|
|
Nervous system disorders
Neurologic Other
|
10.5%
2/19 • Number of events 18
|
0.00%
0/28
|
|
Nervous system disorders
Neuropathy - motor
|
5.3%
1/19 • Number of events 2
|
0.00%
0/28
|
|
Nervous system disorders
Neuropathy - sensory
|
26.3%
5/19 • Number of events 107
|
42.9%
12/28 • Number of events 178
|
|
Investigations
Neutrophils/granulocytes
|
10.5%
2/19 • Number of events 7
|
0.00%
0/28
|
|
Eye disorders
Occular Other
|
15.8%
3/19 • Number of events 19
|
0.00%
0/28
|
|
General disorders
Pain Other
|
57.9%
11/19 • Number of events 150
|
21.4%
6/28 • Number of events 43
|
|
Cardiac disorders
Palpitations
|
10.5%
2/19 • Number of events 4
|
0.00%
0/28
|
|
Skin and subcutaneous tissue disorders
pigmentation changes
|
5.3%
1/19 • Number of events 12
|
0.00%
0/28
|
|
Investigations
Platelets
|
36.8%
7/19 • Number of events 30
|
32.1%
9/28 • Number of events 79
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
5.3%
1/19 • Number of events 5
|
0.00%
0/28
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
10.5%
2/19 • Number of events 12
|
10.7%
3/28 • Number of events 11
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Other
|
10.5%
2/19 • Number of events 24
|
0.00%
0/28
|
|
Injury, poisoning and procedural complications
Radiation dermatitis
|
5.3%
1/19 • Number of events 8
|
0.00%
0/28
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
36.8%
7/19 • Number of events 45
|
35.7%
10/28 • Number of events 45
|
|
Renal and urinary disorders
Renal/Genitourinary Other
|
10.5%
2/19 • Number of events 3
|
7.1%
2/28 • Number of events 4
|
|
General disorders
Rigor, chills
|
10.5%
2/19 • Number of events 3
|
0.00%
0/28
|
|
General disorders
Sense of smell
|
5.3%
1/19 • Number of events 8
|
0.00%
0/28
|
|
Investigations
SGOT (AST)
|
15.8%
3/19 • Number of events 18
|
14.3%
4/28 • Number of events 13
|
|
Investigations
SGPT (ALT)
|
15.8%
3/19 • Number of events 16
|
14.3%
4/28 • Number of events 18
|
|
Cardiac disorders
Sinus tachycardia
|
5.3%
1/19 • Number of events 1
|
0.00%
0/28
|
|
Skin and subcutaneous tissue disorders
Skin Other
|
26.3%
5/19 • Number of events 27
|
7.1%
2/28 • Number of events 12
|
|
Infections and infestations
Stomatitis/phyaryngitis
|
10.5%
2/19 • Number of events 3
|
0.00%
0/28
|
|
Cardiac disorders
Supraventricular arrhythmias
|
0.00%
0/19
|
7.1%
2/28 • Number of events 14
|
|
Skin and subcutaneous tissue disorders
Sweating
|
31.6%
6/19 • Number of events 48
|
10.7%
3/28 • Number of events 29
|
|
General disorders
Taste disturbance
|
10.5%
2/19 • Number of events 10
|
7.1%
2/28 • Number of events 9
|
|
General disorders
Tumor Pain
|
15.8%
3/19 • Number of events 37
|
39.3%
11/28 • Number of events 80
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
10.5%
2/19 • Number of events 30
|
7.1%
2/28 • Number of events 17
|
|
Eye disorders
Vision/blurred vision
|
5.3%
1/19 • Number of events 3
|
0.00%
0/28
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/stridor/layrynx
|
10.5%
2/19 • Number of events 11
|
0.00%
0/28
|
|
Gastrointestinal disorders
Vomiting
|
63.2%
12/19 • Number of events 56
|
50.0%
14/28 • Number of events 54
|
|
Investigations
Weight gain
|
5.3%
1/19 • Number of events 2
|
0.00%
0/28
|
|
Investigations
Weight loss
|
0.00%
0/19
|
14.3%
4/28 • Number of events 24
|
|
Infections and infestations
Wound infection
|
5.3%
1/19 • Number of events 1
|
14.3%
4/28 • Number of events 12
|
|
Infections and infestations
Wound non-infectious
|
0.00%
0/19
|
7.1%
2/28 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
36.8%
7/19 • Number of events 65
|
21.4%
6/28 • Number of events 18
|
|
Injury, poisoning and procedural complications
bruising
|
10.5%
2/19 • Number of events 6
|
0.00%
0/28
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place