Trial Outcomes & Findings for Phase I/II Study of Combination of Sorafenib, Vorinostat, and Bortezomib for the Treatment of Acute Myeloid Leukemia With Complex- or Poor-risk (Monosomy 5/7) Cytogenetics or FLT3-ITD Positive Genotype (NCT NCT01534260)
NCT ID: NCT01534260
Last Updated: 2018-08-17
Results Overview
The number of patients who had a DLT during the dose finding/confirming portion (Phase I) of the trial for the safety of the combination of sorafenib, vorinostat, and bortezomib.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
37 participants
Primary outcome timeframe
up to 9 months
Results posted on
2018-08-17
Participant Flow
This protocol was based on enrolling up to 44 patients with 2 to 30 patients in phase I and 14 patients in phase II. The study enrolled 37 patients with 17 in phase I and 20 in phase II.
Participant milestones
| Measure |
Phase I Dose Escalating
escalating dose cohorts of sorafenib, vorinostat and bortezomib. All cohorts will receive sorafenib from day 1 to 14 and vorinostat from day 1 to 4 and day 8 to 12. Bortezomib will be given on days 1 and 8 for all cohorts, with cohorts 4 and 5 also receiving bortezomib on days 4 and 11 for cycles 1 through 4. This will be followed by 7 days of rest. Therefore each cycle will be 21 days.
|
Phase II at MTD
patients received sorafenib at 400 mg bid from day 1 to 14 and vorinostat 200 mg bid from day 1 to 14. Bortezomib will be given at 1.3 mg/m2 on days 1, 4, 8 and 11 for cycles 1-4, and then on days 1 and 8 for cycle 5 and beyond. Bortezomib will be given on days 1 and 8 beyond 4 cycles to reduce the risk of neurotoxicity.
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
20
|
|
Overall Study
COMPLETED
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
16
|
20
|
Reasons for withdrawal
| Measure |
Phase I Dose Escalating
escalating dose cohorts of sorafenib, vorinostat and bortezomib. All cohorts will receive sorafenib from day 1 to 14 and vorinostat from day 1 to 4 and day 8 to 12. Bortezomib will be given on days 1 and 8 for all cohorts, with cohorts 4 and 5 also receiving bortezomib on days 4 and 11 for cycles 1 through 4. This will be followed by 7 days of rest. Therefore each cycle will be 21 days.
|
Phase II at MTD
patients received sorafenib at 400 mg bid from day 1 to 14 and vorinostat 200 mg bid from day 1 to 14. Bortezomib will be given at 1.3 mg/m2 on days 1, 4, 8 and 11 for cycles 1-4, and then on days 1 and 8 for cycle 5 and beyond. Bortezomib will be given on days 1 and 8 beyond 4 cycles to reduce the risk of neurotoxicity.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
8
|
|
Overall Study
Death
|
2
|
0
|
|
Overall Study
Lack of Efficacy
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
|
Overall Study
Disease Progression
|
8
|
6
|
|
Overall Study
Physician Decision
|
3
|
1
|
|
Overall Study
No treatment, per protocol
|
0
|
1
|
Baseline Characteristics
Phase I/II Study of Combination of Sorafenib, Vorinostat, and Bortezomib for the Treatment of Acute Myeloid Leukemia With Complex- or Poor-risk (Monosomy 5/7) Cytogenetics or FLT3-ITD Positive Genotype
Baseline characteristics by cohort
| Measure |
Phase I Dose Escalating
n=17 Participants
escalating dose cohorts of sorafenib, vorinostat and bortezomib. All cohorts will receive sorafenib from day 1 to 14 and vorinostat from day 1 to 4 and day 8 to 12. Bortezomib will be given on days 1 and 8 for all cohorts, with cohorts 4 and 5 also receiving bortezomib on days 4 and 11 for cycles 1 through 4. This will be followed by 7 days of rest. Therefore each cycle will be 21 days.
|
Phase II at MTD
n=20 Participants
patients received sorafenib at 400 mg bid from day 1 to 14 and vorinostat 200 mg bid from day 1 to 14. Bortezomib will be given at 1.3 mg/m2 on days 1, 4, 8 and 11 for cycles 1-4, and then on days 1 and 8 for cycle 5 and beyond. Bortezomib will be given on days 1 and 8 beyond 4 cycles to reduce the risk of neurotoxicity.
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age, Continuous
|
51.6 years
STANDARD_DEVIATION 14.2 • n=5 Participants
|
58.2 years
STANDARD_DEVIATION 14.8 • n=7 Participants
|
55.2 years
STANDARD_DEVIATION 14.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 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
|
17 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 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
|
1 Participants
n=5 Participants
|
0 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
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
33 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
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 9 monthsPopulation: All Phase I patients receiving at least one dose of study drug and having at least one evaluable post-baseline visit
The number of patients who had a DLT during the dose finding/confirming portion (Phase I) of the trial for the safety of the combination of sorafenib, vorinostat, and bortezomib.
Outcome measures
| Measure |
Phase I Dose Escalating
n=17 Participants
escalating dose cohorts of sorafenib, vorinostat and bortezomib. All cohorts will receive sorafenib from day 1 to 14 and vorinostat from day 1 to 4 and day 8 to 12. Bortezomib will be given on days 1 and 8 for all cohorts, with cohorts 4 and 5 also receiving bortezomib on days 4 and 11 for cycles 1 through 4. This will be followed by 7 days of rest. Therefore each cycle will be 21 days.
|
|---|---|
|
Number of Patients With Dose Limiting Toxicity
|
0 Participants
|
PRIMARY outcome
Timeframe: up to 9 monthsPopulation: All Phase II patients who received at least one dose of study drug and had at least one evaluable post-baseline visit
Evaluate the overall response rate of patients receiving therapy. Patients are considered as having a response if their overall response is Partial Response or better. The percentage of patients achieving this and the exact 95% confidence interval will be calculated. Responses will be defined using the response criteria determined by the International Working Group for AML.
Outcome measures
| Measure |
Phase I Dose Escalating
n=15 Participants
escalating dose cohorts of sorafenib, vorinostat and bortezomib. All cohorts will receive sorafenib from day 1 to 14 and vorinostat from day 1 to 4 and day 8 to 12. Bortezomib will be given on days 1 and 8 for all cohorts, with cohorts 4 and 5 also receiving bortezomib on days 4 and 11 for cycles 1 through 4. This will be followed by 7 days of rest. Therefore each cycle will be 21 days.
|
|---|---|
|
Phase II - Percentage of Patients With a Partial Response or Greater
|
40.0 percentage of participants
Interval 16.3 to 67.7
|
SECONDARY outcome
Timeframe: Up to one yearPopulation: All Phase II patients who received at least one dose of study drug, had at least one evaluable post-baseline visit, and achieved complete remission
Will be examined using Kaplan-Meier estimates. Time from date of confirmed complete remission to date of relapse. The observations of patients who died or remained alive and relapse free were censored at date of death or last disease evaluation, respectively.
Outcome measures
| Measure |
Phase I Dose Escalating
n=3 Participants
escalating dose cohorts of sorafenib, vorinostat and bortezomib. All cohorts will receive sorafenib from day 1 to 14 and vorinostat from day 1 to 4 and day 8 to 12. Bortezomib will be given on days 1 and 8 for all cohorts, with cohorts 4 and 5 also receiving bortezomib on days 4 and 11 for cycles 1 through 4. This will be followed by 7 days of rest. Therefore each cycle will be 21 days.
|
|---|---|
|
Phase II - Time to Relapse
|
32 days
Interval 22.0 to 42.0
|
SECONDARY outcome
Timeframe: Up to one yearPopulation: All Phase II patients who received treatment.
Number of unique patients who had a treatment-related (possible, probable or definite) adverse events that were graded 3 or higher.
Outcome measures
| Measure |
Phase I Dose Escalating
n=20 Participants
escalating dose cohorts of sorafenib, vorinostat and bortezomib. All cohorts will receive sorafenib from day 1 to 14 and vorinostat from day 1 to 4 and day 8 to 12. Bortezomib will be given on days 1 and 8 for all cohorts, with cohorts 4 and 5 also receiving bortezomib on days 4 and 11 for cycles 1 through 4. This will be followed by 7 days of rest. Therefore each cycle will be 21 days.
|
|---|---|
|
Phase II - Treatment-Related Adverse Events Grade 3 or Higher
|
4 Participants
|
Adverse Events
Phase I Dose Escalating
Serious events: 7 serious events
Other events: 16 other events
Deaths: 0 deaths
Phase II at MTD
Serious events: 11 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase I Dose Escalating
n=17 participants at risk
escalating dose cohorts of sorafenib, vorinostat and bortezomib. All cohorts will receive sorafenib from day 1 to 14 and vorinostat from day 1 to 4 and day 8 to 12. Bortezomib will be given on days 1 and 8 for all cohorts, with cohorts 4 and 5 also receiving bortezomib on days 4 and 11 for cycles 1 through 4. This will be followed by 7 days of rest. Therefore each cycle will be 21 days.
|
Phase II at MTD
n=20 participants at risk
patients received sorafenib at 400 mg bid from day 1 to 14 and vorinostat 200 mg bid from day 1 to 14. Bortezomib will be given at 1.3 mg/m2 on days 1, 4, 8 and 11 for cycles 1-4, and then on days 1 and 8 for cycle 5 and beyond. Bortezomib will be given on days 1 and 8 beyond 4 cycles to reduce the risk of neurotoxicity.
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
11.8%
2/17 • Up to one year
|
5.0%
1/20 • Up to one year
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/17 • Up to one year
|
5.0%
1/20 • Up to one year
|
|
Eye disorders
Eye disorders - Other
|
0.00%
0/17 • Up to one year
|
5.0%
1/20 • Up to one year
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/17 • Up to one year
|
10.0%
2/20 • Up to one year
|
|
Gastrointestinal disorders
Nausea
|
5.9%
1/17 • Up to one year
|
0.00%
0/20 • Up to one year
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
5.9%
1/17 • Up to one year
|
0.00%
0/20 • Up to one year
|
|
General disorders
Fever
|
17.6%
3/17 • Up to one year
|
10.0%
2/20 • Up to one year
|
|
Infections and infestations
Lung infection
|
5.9%
1/17 • Up to one year
|
5.0%
1/20 • Up to one year
|
|
Infections and infestations
Sepsis
|
5.9%
1/17 • Up to one year
|
10.0%
2/20 • Up to one year
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/17 • Up to one year
|
5.0%
1/20 • Up to one year
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/17 • Up to one year
|
5.0%
1/20 • Up to one year
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/17 • Up to one year
|
5.0%
1/20 • Up to one year
|
|
Nervous system disorders
Syncope
|
0.00%
0/17 • Up to one year
|
5.0%
1/20 • Up to one year
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.9%
1/17 • Up to one year
|
0.00%
0/20 • Up to one year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/17 • Up to one year
|
10.0%
2/20 • Up to one year
|
Other adverse events
| Measure |
Phase I Dose Escalating
n=17 participants at risk
escalating dose cohorts of sorafenib, vorinostat and bortezomib. All cohorts will receive sorafenib from day 1 to 14 and vorinostat from day 1 to 4 and day 8 to 12. Bortezomib will be given on days 1 and 8 for all cohorts, with cohorts 4 and 5 also receiving bortezomib on days 4 and 11 for cycles 1 through 4. This will be followed by 7 days of rest. Therefore each cycle will be 21 days.
|
Phase II at MTD
n=20 participants at risk
patients received sorafenib at 400 mg bid from day 1 to 14 and vorinostat 200 mg bid from day 1 to 14. Bortezomib will be given at 1.3 mg/m2 on days 1, 4, 8 and 11 for cycles 1-4, and then on days 1 and 8 for cycle 5 and beyond. Bortezomib will be given on days 1 and 8 beyond 4 cycles to reduce the risk of neurotoxicity.
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
5.9%
1/17 • Up to one year
|
5.0%
1/20 • Up to one year
|
|
Blood and lymphatic system disorders
Leukocytosis
|
5.9%
1/17 • Up to one year
|
0.00%
0/20 • Up to one year
|
|
Blood and lymphatic system disorders
Spleen disorder
|
5.9%
1/17 • Up to one year
|
0.00%
0/20 • Up to one year
|
|
Cardiac disorders
Atrial fibrillation
|
11.8%
2/17 • Up to one year
|
0.00%
0/20 • Up to one year
|
|
Cardiac disorders
Atrial flutter
|
5.9%
1/17 • Up to one year
|
0.00%
0/20 • Up to one year
|
|
Cardiac disorders
Cardiac arrest
|
5.9%
1/17 • Up to one year
|
0.00%
0/20 • Up to one year
|
|
Cardiac disorders
Cardiac disorders - Other
|
5.9%
1/17 • Up to one year
|
0.00%
0/20 • Up to one year
|
|
Cardiac disorders
Chest pain - cardiac
|
5.9%
1/17 • Up to one year
|
5.0%
1/20 • Up to one year
|
|
Cardiac disorders
Sinus bradycardia
|
5.9%
1/17 • Up to one year
|
0.00%
0/20 • Up to one year
|
|
Cardiac disorders
Sinus tachycardia
|
5.9%
1/17 • Up to one year
|
10.0%
2/20 • Up to one year
|
|
Cardiac disorders
Supraventricular tachycardia
|
5.9%
1/17 • Up to one year
|
0.00%
0/20 • Up to one year
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/17 • Up to one year
|
5.0%
1/20 • Up to one year
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/17 • Up to one year
|
5.0%
1/20 • Up to one year
|
|
Ear and labyrinth disorders
Ear pain
|
5.9%
1/17 • Up to one year
|
0.00%
0/20 • Up to one year
|
|
Endocrine disorders
Endocrine disorders - Other
|
5.9%
1/17 • Up to one year
|
0.00%
0/20 • Up to one year
|
|
Eye disorders
Eye disorders - Other
|
0.00%
0/17 • Up to one year
|
10.0%
2/20 • Up to one year
|
|
Eye disorders
Scleral disorder
|
0.00%
0/17 • Up to one year
|
5.0%
1/20 • Up to one year
|
|
Eye disorders
Uveitis
|
0.00%
0/17 • Up to one year
|
5.0%
1/20 • Up to one year
|
|
Gastrointestinal disorders
Abdominal distension
|
5.9%
1/17 • Up to one year
|
0.00%
0/20 • Up to one year
|
|
Gastrointestinal disorders
Abdominal pain
|
5.9%
1/17 • Up to one year
|
20.0%
4/20 • Up to one year
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/17 • Up to one year
|
5.0%
1/20 • Up to one year
|
|
Gastrointestinal disorders
Constipation
|
11.8%
2/17 • Up to one year
|
25.0%
5/20 • Up to one year
|
|
Gastrointestinal disorders
Diarrhea
|
64.7%
11/17 • Up to one year
|
60.0%
12/20 • Up to one year
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/17 • Up to one year
|
5.0%
1/20 • Up to one year
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
11.8%
2/17 • Up to one year
|
10.0%
2/20 • Up to one year
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
0.00%
0/17 • Up to one year
|
10.0%
2/20 • Up to one year
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
5.9%
1/17 • Up to one year
|
0.00%
0/20 • Up to one year
|
|
Gastrointestinal disorders
Hemorrhoids
|
5.9%
1/17 • Up to one year
|
0.00%
0/20 • Up to one year
|
|
Gastrointestinal disorders
Mucositis oral
|
35.3%
6/17 • Up to one year
|
25.0%
5/20 • Up to one year
|
|
Gastrointestinal disorders
Nausea
|
41.2%
7/17 • Up to one year
|
60.0%
12/20 • Up to one year
|
|
Gastrointestinal disorders
Oral hemorrhage
|
5.9%
1/17 • Up to one year
|
5.0%
1/20 • Up to one year
|
|
Gastrointestinal disorders
Vomiting
|
29.4%
5/17 • Up to one year
|
50.0%
10/20 • Up to one year
|
|
General disorders
Edema face
|
0.00%
0/17 • Up to one year
|
5.0%
1/20 • Up to one year
|
|
General disorders
Edema limbs
|
5.9%
1/17 • Up to one year
|
10.0%
2/20 • Up to one year
|
|
General disorders
Fatigue
|
11.8%
2/17 • Up to one year
|
15.0%
3/20 • Up to one year
|
|
General disorders
Fever
|
11.8%
2/17 • Up to one year
|
20.0%
4/20 • Up to one year
|
|
General disorders
General disorders and administration site conditions - Other
|
23.5%
4/17 • Up to one year
|
5.0%
1/20 • Up to one year
|
|
General disorders
Hypothermia
|
5.9%
1/17 • Up to one year
|
0.00%
0/20 • Up to one year
|
|
General disorders
Localized edema
|
11.8%
2/17 • Up to one year
|
5.0%
1/20 • Up to one year
|
|
General disorders
Malaise
|
5.9%
1/17 • Up to one year
|
0.00%
0/20 • Up to one year
|
|
General disorders
Pain
|
23.5%
4/17 • Up to one year
|
10.0%
2/20 • Up to one year
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/17 • Up to one year
|
5.0%
1/20 • Up to one year
|
|
Infections and infestations
Device related infection
|
5.9%
1/17 • Up to one year
|
0.00%
0/20 • Up to one year
|
|
Infections and infestations
Infections and infestations - Other
|
0.00%
0/17 • Up to one year
|
10.0%
2/20 • Up to one year
|
|
Infections and infestations
Papulopustular rash
|
5.9%
1/17 • Up to one year
|
0.00%
0/20 • Up to one year
|
|
Infections and infestations
Sepsis
|
5.9%
1/17 • Up to one year
|
0.00%
0/20 • Up to one year
|
|
Infections and infestations
Sinusitis
|
0.00%
0/17 • Up to one year
|
10.0%
2/20 • Up to one year
|
|
Injury, poisoning and procedural complications
Bruising
|
5.9%
1/17 • Up to one year
|
0.00%
0/20 • Up to one year
|
|
Injury, poisoning and procedural complications
Fall
|
5.9%
1/17 • Up to one year
|
0.00%
0/20 • Up to one year
|
|
Injury, poisoning and procedural complications
Intestinal stoma site bleeding
|
0.00%
0/17 • Up to one year
|
5.0%
1/20 • Up to one year
|
|
Investigations
INR increased
|
0.00%
0/17 • Up to one year
|
5.0%
1/20 • Up to one year
|
|
Investigations
Urine output decreased
|
5.9%
1/17 • Up to one year
|
0.00%
0/20 • Up to one year
|
|
Investigations
Weight gain
|
5.9%
1/17 • Up to one year
|
0.00%
0/20 • Up to one year
|
|
Metabolism and nutrition disorders
Acidosis
|
11.8%
2/17 • Up to one year
|
5.0%
1/20 • Up to one year
|
|
Metabolism and nutrition disorders
Anorexia
|
35.3%
6/17 • Up to one year
|
10.0%
2/20 • Up to one year
|
|
Metabolism and nutrition disorders
Dehydration
|
5.9%
1/17 • Up to one year
|
15.0%
3/20 • Up to one year
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
5.9%
1/17 • Up to one year
|
0.00%
0/20 • Up to one year
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
5.9%
1/17 • Up to one year
|
0.00%
0/20 • Up to one year
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
11.8%
2/17 • Up to one year
|
0.00%
0/20 • Up to one year
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
5.9%
1/17 • Up to one year
|
0.00%
0/20 • Up to one year
|
|
Metabolism and nutrition disorders
Hypokalemia
|
17.6%
3/17 • Up to one year
|
20.0%
4/20 • Up to one year
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
17.6%
3/17 • Up to one year
|
15.0%
3/20 • Up to one year
|
|
Metabolism and nutrition disorders
Hyponatremia
|
11.8%
2/17 • Up to one year
|
10.0%
2/20 • Up to one year
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
5.9%
1/17 • Up to one year
|
5.0%
1/20 • Up to one year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.8%
2/17 • Up to one year
|
10.0%
2/20 • Up to one year
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.9%
1/17 • Up to one year
|
10.0%
2/20 • Up to one year
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/17 • Up to one year
|
10.0%
2/20 • Up to one year
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
5.9%
1/17 • Up to one year
|
5.0%
1/20 • Up to one year
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness trunk
|
0.00%
0/17 • Up to one year
|
5.0%
1/20 • Up to one year
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other
|
11.8%
2/17 • Up to one year
|
0.00%
0/20 • Up to one year
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/17 • Up to one year
|
5.0%
1/20 • Up to one year
|
|
Musculoskeletal and connective tissue disorders
Neck soft tissue necrosis
|
5.9%
1/17 • Up to one year
|
0.00%
0/20 • Up to one year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other
|
5.9%
1/17 • Up to one year
|
0.00%
0/20 • Up to one year
|
|
Nervous system disorders
Dizziness
|
11.8%
2/17 • Up to one year
|
0.00%
0/20 • Up to one year
|
|
Nervous system disorders
Headache
|
11.8%
2/17 • Up to one year
|
20.0%
4/20 • Up to one year
|
|
Nervous system disorders
Intracranial hemorrhage
|
5.9%
1/17 • Up to one year
|
0.00%
0/20 • Up to one year
|
|
Nervous system disorders
Syncope
|
5.9%
1/17 • Up to one year
|
0.00%
0/20 • Up to one year
|
|
Psychiatric disorders
Confusion
|
17.6%
3/17 • Up to one year
|
5.0%
1/20 • Up to one year
|
|
Psychiatric disorders
Insomnia
|
5.9%
1/17 • Up to one year
|
5.0%
1/20 • Up to one year
|
|
Renal and urinary disorders
Acute kidney injury
|
23.5%
4/17 • Up to one year
|
10.0%
2/20 • Up to one year
|
|
Renal and urinary disorders
Renal and urinary disorders - Other
|
5.9%
1/17 • Up to one year
|
5.0%
1/20 • Up to one year
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/17 • Up to one year
|
5.0%
1/20 • Up to one year
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
5.9%
1/17 • Up to one year
|
0.00%
0/20 • Up to one year
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
5.9%
1/17 • Up to one year
|
0.00%
0/20 • Up to one year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
23.5%
4/17 • Up to one year
|
10.0%
2/20 • Up to one year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
23.5%
4/17 • Up to one year
|
0.00%
0/20 • Up to one year
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/17 • Up to one year
|
5.0%
1/20 • Up to one year
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
5.9%
1/17 • Up to one year
|
5.0%
1/20 • Up to one year
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
17.6%
3/17 • Up to one year
|
0.00%
0/20 • Up to one year
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
11.8%
2/17 • Up to one year
|
0.00%
0/20 • Up to one year
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.9%
1/17 • Up to one year
|
0.00%
0/20 • Up to one year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
5.9%
1/17 • Up to one year
|
0.00%
0/20 • Up to one year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
|
5.9%
1/17 • Up to one year
|
20.0%
4/20 • Up to one year
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
5.9%
1/17 • Up to one year
|
5.0%
1/20 • Up to one year
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/17 • Up to one year
|
5.0%
1/20 • Up to one year
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
5.9%
1/17 • Up to one year
|
0.00%
0/20 • Up to one year
|
|
Skin and subcutaneous tissue disorders
Bullous dermatitis
|
11.8%
2/17 • Up to one year
|
0.00%
0/20 • Up to one year
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.9%
1/17 • Up to one year
|
0.00%
0/20 • Up to one year
|
|
Skin and subcutaneous tissue disorders
Erythroderma
|
11.8%
2/17 • Up to one year
|
0.00%
0/20 • Up to one year
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
5.9%
1/17 • Up to one year
|
0.00%
0/20 • Up to one year
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.9%
1/17 • Up to one year
|
0.00%
0/20 • Up to one year
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
17.6%
3/17 • Up to one year
|
5.0%
1/20 • Up to one year
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
23.5%
4/17 • Up to one year
|
15.0%
3/20 • Up to one year
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
0.00%
0/17 • Up to one year
|
5.0%
1/20 • Up to one year
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
5.9%
1/17 • Up to one year
|
0.00%
0/20 • Up to one year
|
|
Vascular disorders
Flushing
|
5.9%
1/17 • Up to one year
|
0.00%
0/20 • Up to one year
|
|
Vascular disorders
Hot flashes
|
5.9%
1/17 • Up to one year
|
0.00%
0/20 • Up to one year
|
|
Vascular disorders
Hypertension
|
5.9%
1/17 • Up to one year
|
15.0%
3/20 • Up to one year
|
|
Vascular disorders
Hypotension
|
23.5%
4/17 • Up to one year
|
10.0%
2/20 • Up to one year
|
|
Vascular disorders
Superficial thrombophlebitis
|
5.9%
1/17 • Up to one year
|
0.00%
0/20 • Up to one year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place