Trial Outcomes & Findings for Ofatumumab/Methylprednisolone and Ofatumumab/Lenalidomide for Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) (NCT NCT01497496)
NCT ID: NCT01497496
Last Updated: 2021-04-27
Results Overview
ORR at 3 months. Assessment for response will be made following the National Cancer Institute Working Group (NCIWG) 2008 Chronic Lymphocytic Leukemia (CLL) criteria for response. Objective response = Complete Response (disappearance of all target lesions) + Partial Response (\>=30% decrease in the sum of the longest diameter of target lesions) per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
29 participants
Primary outcome timeframe
3 Months
Results posted on
2021-04-27
Participant Flow
Participant milestones
| Measure |
Immunotherapy
Combination regimen consisting of high dose methylprednisolone combined with ofatumumab, followed by consolidative therapy with lenalidomide in combination with ofatumumab. Time of therapy: until disease progression or toxicity.
|
|---|---|
|
Overall Study
STARTED
|
29
|
|
Overall Study
COMPLETED
|
29
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ofatumumab/Methylprednisolone and Ofatumumab/Lenalidomide for Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
Baseline characteristics by cohort
| Measure |
Immunotherapy
n=29 Participants
Combination regimen consisting of high dose methylprednisolone combined with ofatumumab, followed by consolidative therapy with lenalidomide in combination with ofatumumab.
High Dose Methylprednisolone (HDMP): 1000 mg/m\^2 on Cycle 1: Day 1, 8, 15, 22; Cycle 2: Day 1, 15; Cycle 3: Day 1, 15
Ofatumumab: Ofatumumab infusion will be administered immediately after HDMP. 300 mg on Cycle 1 Day 1. 2000 mg on Cycle 1: Day 8, 15, 22; Cycle 2: Day 1, 15; Cycle 3: Day 1, 15; Cycle 6: Day 1; Cycle 8: Day 1; Cycle 10: Day 1: Cycle 12: Day 1
Lenalidomide: The lenalidomide treatment will start with cycle 4. 5-10 mg pd Days 1-28 as per Creatinine Clearance (CrCl)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 MonthsPopulation: Evaluable participants
ORR at 3 months. Assessment for response will be made following the National Cancer Institute Working Group (NCIWG) 2008 Chronic Lymphocytic Leukemia (CLL) criteria for response. Objective response = Complete Response (disappearance of all target lesions) + Partial Response (\>=30% decrease in the sum of the longest diameter of target lesions) per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0)
Outcome measures
| Measure |
Immunotherapy
n=27 Participants
Combination regimen consisting of high dose methylprednisolone combined with ofatumumab, followed by consolidative therapy with lenalidomide in combination with ofatumumab.
High Dose Methylprednisolone (HDMP): 1000 mg/m\^2 on Cycle 1: Day 1, 8, 15, 22; Cycle 2: Day 1, 15; Cycle 3: Day 1, 15
Ofatumumab: Ofatumumab infusion will be administered immediately after HDMP. 300 mg on Cycle 1 Day 1. 2000 mg on Cycle 1: Day 8, 15, 22; Cycle 2: Day 1, 15; Cycle 3: Day 1, 15; Cycle 6: Day 1; Cycle 8: Day 1; Cycle 10: Day 1: Cycle 12: Day 1
Lenalidomide: The lenalidomide treatment will start with cycle 4. 5-10 mg pd Days 1-28 as per Creatinine Clearance (CrCl)
|
|---|---|
|
Objective Response Rate (ORR)
|
48.3 percentage of participants
|
SECONDARY outcome
Timeframe: 36 MonthsPopulation: Data not collected (likely futility from low accrual due to competing commercially available treatment)
Progression-free survival (PFS), defined as the time from study entry to disease progression, relapse or death due to any cause, whichever is earlier, will be summarized with the Kaplan-Meier curve. Progressive Disease (PD) defined according to NCIWG 2008 CLL Criteria for Response.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 36 MonthsPopulation: Data not collected (likely futility from low accrual due to competing commercially available treatment)
Overall Survival Time: Time from initiation of treatment to time of death. Overall survival will be summarized with the Kaplan-Meier curve.
Outcome measures
Outcome data not reported
Adverse Events
Immunotherapy
Serious events: 25 serious events
Other events: 29 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Immunotherapy
n=29 participants at risk
Combination regimen consisting of high dose methylprednisolone combined with ofatumumab, followed by consolidative therapy with lenalidomide in combination with ofatumumab.
High Dose Methylprednisolone (HDMP): 1000 mg/m\^2 on Cycle 1: Day 1, 8, 15, 22; Cycle 2: Day 1, 15; Cycle 3: Day 1, 15
Ofatumumab: Ofatumumab infusion will be administered immediately after HDMP. 300 mg on Cycle 1 Day 1. 2000 mg on Cycle 1: Day 8, 15, 22; Cycle 2: Day 1, 15; Cycle 3: Day 1, 15; Cycle 6: Day 1; Cycle 8: Day 1; Cycle 10: Day 1: Cycle 12: Day 1
Lenalidomide: The lenalidomide treatment will start with cycle 4. 5-10 mg pd Days 1-28 as per Creatinine Clearance (CrCl)
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
13.8%
4/29 • Number of events 6 • 7 years, 6 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
31.0%
9/29 • Number of events 13 • 7 years, 6 months
|
|
Blood and lymphatic system disorders
Leukocytosis
|
6.9%
2/29 • Number of events 4 • 7 years, 6 months
|
|
Cardiac disorders
Atrial fibrillation
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
Gastrointestinal disorders
Abdominal Pain
|
6.9%
2/29 • Number of events 2 • 7 years, 6 months
|
|
Gastrointestinal disorders
Colitis
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
Gastrointestinal disorders
Diarrhea
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders -Other
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
Gastrointestinal disorders
Diverticulitis
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
General disorders
Death
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
General disorders
Fatigue
|
10.3%
3/29 • Number of events 4 • 7 years, 6 months
|
|
General disorders
Fever
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
General disorders
General disorders and administrative site conditions -Other
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
General disorders
Multi-organ failure
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
General disorders
Leg pain
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
Infections and infestations
Enterocolitis infectious
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
Infections and infestations
Infections and infestations - Other
|
20.7%
6/29 • Number of events 6 • 7 years, 6 months
|
|
Infections and infestations
Lung infection
|
31.0%
9/29 • Number of events 10 • 7 years, 6 months
|
|
Infections and infestations
Sepsis
|
13.8%
4/29 • Number of events 4 • 7 years, 6 months
|
|
Infections and infestations
Skin infection
|
6.9%
2/29 • Number of events 2 • 7 years, 6 months
|
|
Infections and infestations
Upper respiratory infection
|
10.3%
3/29 • Number of events 4 • 7 years, 6 months
|
|
Infections and infestations
Urinary tract infection
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
Investigations
Alkaline phosphatase increased
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
Investigations
Aspartate aminotransferase increased
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
Investigations
Blood bilirubin increased
|
3.4%
1/29 • Number of events 2 • 7 years, 6 months
|
|
Investigations
Creatinine increased
|
3.4%
1/29 • Number of events 2 • 7 years, 6 months
|
|
Investigations
Neutrophil count decreased
|
86.2%
25/29 • Number of events 107 • 7 years, 6 months
|
|
Investigations
Platelet count decreased
|
27.6%
8/29 • Number of events 23 • 7 years, 6 months
|
|
Investigations
White blood cell decreased
|
41.4%
12/29 • Number of events 36 • 7 years, 6 months
|
|
Metabolism and nutrition disorders
Dehydration
|
10.3%
3/29 • Number of events 3 • 7 years, 6 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
13.8%
4/29 • Number of events 8 • 7 years, 6 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
6.9%
2/29 • Number of events 2 • 7 years, 6 months
|
|
Nervous system disorders
Dizziness
|
6.9%
2/29 • Number of events 2 • 7 years, 6 months
|
|
Psychiatric disorders
Insomnia
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
Renal and urinary disorders
Renal calculi
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.9%
2/29 • Number of events 2 • 7 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Penumonitis
|
6.9%
2/29 • Number of events 2 • 7 years, 6 months
|
|
Vascular disorders
Hypotension
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
Vascular disorders
Thromboembolic event
|
6.9%
2/29 • Number of events 2 • 7 years, 6 months
|
|
Vascular disorders
Vascular disorders - Other
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
Other adverse events
| Measure |
Immunotherapy
n=29 participants at risk
Combination regimen consisting of high dose methylprednisolone combined with ofatumumab, followed by consolidative therapy with lenalidomide in combination with ofatumumab.
High Dose Methylprednisolone (HDMP): 1000 mg/m\^2 on Cycle 1: Day 1, 8, 15, 22; Cycle 2: Day 1, 15; Cycle 3: Day 1, 15
Ofatumumab: Ofatumumab infusion will be administered immediately after HDMP. 300 mg on Cycle 1 Day 1. 2000 mg on Cycle 1: Day 8, 15, 22; Cycle 2: Day 1, 15; Cycle 3: Day 1, 15; Cycle 6: Day 1; Cycle 8: Day 1; Cycle 10: Day 1: Cycle 12: Day 1
Lenalidomide: The lenalidomide treatment will start with cycle 4. 5-10 mg pd Days 1-28 as per Creatinine Clearance (CrCl)
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
20.7%
6/29 • Number of events 8 • 7 years, 6 months
|
|
Blood and lymphatic system disorders
Intermittent anemia
|
6.9%
2/29 • Number of events 2 • 7 years, 6 months
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
Blood and lymphatic system disorders
Leukocytosis -leukopenia
|
3.4%
1/29 • Number of events 2 • 7 years, 6 months
|
|
Blood and lymphatic system disorders
Intermittent Lymph node pain
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
Blood and lymphatic system disorders
Lymph node pain - abdominal
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
Blood and lymphatic system disorders
Lymph node pain - pain & swelling
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
Cardiac disorders
Atrial fibrillation
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
Cardiac disorders
Cardiac disorders - Other
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
Cardiac disorders
Cardiac disorders -other
|
6.9%
2/29 • Number of events 2 • 7 years, 6 months
|
|
Cardiac disorders
Palpitations
|
10.3%
3/29 • Number of events 3 • 7 years, 6 months
|
|
Cardiac disorders
Sinus bradycardia
|
6.9%
2/29 • Number of events 2 • 7 years, 6 months
|
|
Cardiac disorders
Sinus tachycardia
|
6.9%
2/29 • Number of events 2 • 7 years, 6 months
|
|
Ear and labyrinth disorders
Ear pain
|
10.3%
3/29 • Number of events 3 • 7 years, 6 months
|
|
Ear and labyrinth disorders
Hearing impairment
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
Ear and labyrinth disorders
Middle ear inflammation
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
Ear and labyrinth disorders
Vertigo
|
6.9%
2/29 • Number of events 2 • 7 years, 6 months
|
|
Endocrine disorders
Endocrine disorders Other
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
Endocrine disorders
Endocrine disorders - Other
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
Eye disorders
Blurred vision
|
13.8%
4/29 • Number of events 4 • 7 years, 6 months
|
|
Eye disorders
visual disturbances
|
6.9%
2/29 • Number of events 2 • 7 years, 6 months
|
|
Eye disorders
Conjunctivitis
|
6.9%
2/29 • Number of events 2 • 7 years, 6 months
|
|
Eye disorders
Dry eye
|
6.9%
2/29 • Number of events 2 • 7 years, 6 months
|
|
Eye disorders
Eye disorders - Other
|
20.7%
6/29 • Number of events 6 • 7 years, 6 months
|
|
Eye disorders
Eye pain
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
Eye disorders
Keratitis
|
3.4%
1/29 • Number of events 3 • 7 years, 6 months
|
|
Eye disorders
Watering eyes
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
Gastrointestinal disorders
Abdominal cramping
|
10.3%
3/29 • Number of events 3 • 7 years, 6 months
|
|
Gastrointestinal disorders
Abdominal discomfort
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
Gastrointestinal disorders
Abdominal pain
|
31.0%
9/29 • Number of events 10 • 7 years, 6 months
|
|
Gastrointestinal disorders
Abdominal bloating
|
20.7%
6/29 • Number of events 6 • 7 years, 6 months
|
|
Gastrointestinal disorders
Constipation
|
58.6%
17/29 • Number of events 21 • 7 years, 6 months
|
|
Gastrointestinal disorders
Diarrhea
|
55.2%
16/29 • Number of events 31 • 7 years, 6 months
|
|
Gastrointestinal disorders
Dry mouth
|
6.9%
2/29 • Number of events 2 • 7 years, 6 months
|
|
Gastrointestinal disorders
Dyspepsia
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
Gastrointestinal disorders
Dysphagia
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
Gastrointestinal disorders
Flatulence
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
Gastrointestinal disorders
Gastritis
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
Gastrointestinal disorders
Gastrointestinal reflux disease
|
17.2%
5/29 • Number of events 11 • 7 years, 6 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders -Other
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
6.9%
2/29 • Number of events 3 • 7 years, 6 months
|
|
Gastrointestinal disorders
Gastroparesis, mild
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
Gastrointestinal disorders
Mucositis oral
|
10.3%
3/29 • Number of events 3 • 7 years, 6 months
|
|
Gastrointestinal disorders
Nausea, intermittent
|
13.8%
4/29 • Number of events 6 • 7 years, 6 months
|
|
Gastrointestinal disorders
Nausea
|
41.4%
12/29 • Number of events 13 • 7 years, 6 months
|
|
Gastrointestinal disorders
Oral dysesthesia
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
Gastrointestinal disorders
Oral pain
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
Gastrointestinal disorders
Stomach pain
|
6.9%
2/29 • Number of events 3 • 7 years, 6 months
|
|
Gastrointestinal disorders
Toothache
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
Gastrointestinal disorders
Vomiting, intermittent
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
Gastrointestinal disorders
Vomiting
|
27.6%
8/29 • Number of events 9 • 7 years, 6 months
|
|
General disorders
Chills
|
34.5%
10/29 • Number of events 11 • 7 years, 6 months
|
|
Gastrointestinal disorders
Rigors
|
6.9%
2/29 • Number of events 2 • 7 years, 6 months
|
|
General disorders
Edema, face
|
6.9%
2/29 • Number of events 2 • 7 years, 6 months
|
|
General disorders
Edema, limbs
|
41.4%
12/29 • Number of events 21 • 7 years, 6 months
|
|
General disorders
Fatigue
|
55.2%
16/29 • Number of events 24 • 7 years, 6 months
|
|
General disorders
Fever
|
41.4%
12/29 • Number of events 17 • 7 years, 6 months
|
|
General disorders
Flu like symptoms
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
General disorders
Gait disturbance
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
General disorders
Hemorrhoids
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
General disorders
Infusion related reaction
|
13.8%
4/29 • Number of events 4 • 7 years, 6 months
|
|
General disorders
Irritability
|
20.7%
6/29 • Number of events 6 • 7 years, 6 months
|
|
General disorders
Malaise
|
6.9%
2/29 • Number of events 2 • 7 years, 6 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
Musculoskeletal and connective tissue disorders
Muscle pain
|
6.9%
2/29 • Number of events 2 • 7 years, 6 months
|
|
General disorders
Left hip pain
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
General disorders
port pain
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
General disorders
throat pain
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
General disorders
Inguinal pain, groin pain
|
6.9%
2/29 • Number of events 2 • 7 years, 6 months
|
|
General disorders
General disorders - Other
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
General disorders
Upper axilla pain
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
General disorders
hip pain
|
6.9%
2/29 • Number of events 2 • 7 years, 6 months
|
|
General disorders
Joint pain
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
General disorders
Shooting pain, right leg
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
General disorders
Wrist pain
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
Hepatobiliary disorders
Gallbladder polyps
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
Immune system disorders
Allergic reaction
|
17.2%
5/29 • Number of events 5 • 7 years, 6 months
|
|
Immune system disorders
Cytokine release syndrome
|
10.3%
3/29 • Number of events 3 • 7 years, 6 months
|
|
Infections and infestations
Bronchial infection
|
6.9%
2/29 • Number of events 2 • 7 years, 6 months
|
|
Infections and infestations
Enterocolitis infections
|
6.9%
2/29 • Number of events 2 • 7 years, 6 months
|
|
Infections and infestations
Infections and Infestations - Other
|
13.8%
4/29 • Number of events 5 • 7 years, 6 months
|
|
Infections and infestations
Lung infection
|
10.3%
3/29 • Number of events 3 • 7 years, 6 months
|
|
Infections and infestations
Pharyngitis
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
Infections and infestations
Rhinitis ineffective
|
6.9%
2/29 • Number of events 2 • 7 years, 6 months
|
|
Infections and infestations
Sinusitis
|
13.8%
4/29 • Number of events 4 • 7 years, 6 months
|
|
Infections and infestations
Skin infection
|
10.3%
3/29 • Number of events 5 • 7 years, 6 months
|
|
Infections and infestations
Upper respiratory infection
|
24.1%
7/29 • Number of events 13 • 7 years, 6 months
|
|
Infections and infestations
Urinary tract infection
|
10.3%
3/29 • Number of events 3 • 7 years, 6 months
|
|
Injury, poisoning and procedural complications
Bruising
|
24.1%
7/29 • Number of events 7 • 7 years, 6 months
|
|
Injury, poisoning and procedural complications
Fall
|
6.9%
2/29 • Number of events 2 • 7 years, 6 months
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other
|
10.3%
3/29 • Number of events 3 • 7 years, 6 months
|
|
Injury, poisoning and procedural complications
Papular lesion on face
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
Investigations
alamine aminotransferase increased
|
17.2%
5/29 • Number of events 10 • 7 years, 6 months
|
|
Investigations
Alkaline phosphatase increased
|
17.2%
5/29 • Number of events 12 • 7 years, 6 months
|
|
Investigations
Aspartate aminotransferase increased
|
10.3%
3/29 • Number of events 4 • 7 years, 6 months
|
|
Investigations
Blood bilirubin increased
|
10.3%
3/29 • Number of events 3 • 7 years, 6 months
|
|
Investigations
Creatinine increased
|
17.2%
5/29 • Number of events 7 • 7 years, 6 months
|
|
Investigations
Investigations - Other
|
17.2%
5/29 • Number of events 5 • 7 years, 6 months
|
|
Investigations
Lymphocyte count increased
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
Investigations
Neutrophil count decreased
|
75.9%
22/29 • Number of events 94 • 7 years, 6 months
|
|
Investigations
Platelet count decreased
|
37.9%
11/29 • Number of events 26 • 7 years, 6 months
|
|
Investigations
Weight loss
|
13.8%
4/29 • Number of events 5 • 7 years, 6 months
|
|
Investigations
White blood cell decreased
|
75.9%
22/29 • Number of events 115 • 7 years, 6 months
|
|
Metabolism and nutrition disorders
Anorexia
|
31.0%
9/29 • Number of events 12 • 7 years, 6 months
|
|
Metabolism and nutrition disorders
Dehydration
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
10.3%
3/29 • Number of events 3 • 7 years, 6 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
58.6%
17/29 • Number of events 34 • 7 years, 6 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
17.2%
5/29 • Number of events 6 • 7 years, 6 months
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
6.9%
2/29 • Number of events 2 • 7 years, 6 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
13.8%
4/29 • Number of events 6 • 7 years, 6 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
6.9%
2/29 • Number of events 2 • 7 years, 6 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
6.9%
2/29 • Number of events 2 • 7 years, 6 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
10.3%
3/29 • Number of events 4 • 7 years, 6 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
13.8%
4/29 • Number of events 6 • 7 years, 6 months
|
|
Metabolism and nutrition disorders
Iron overload
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other
|
34.5%
10/29 • Number of events 33 • 7 years, 6 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.4%
1/29 • Number of events 3 • 7 years, 6 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.8%
4/29 • Number of events 5 • 7 years, 6 months
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
24.1%
7/29 • Number of events 7 • 7 years, 6 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, lower limb
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other
|
13.8%
4/29 • Number of events 4 • 7 years, 6 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
17.2%
5/29 • Number of events 5 • 7 years, 6 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
17.2%
5/29 • Number of events 5 • 7 years, 6 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
13.8%
4/29 • Number of events 5 • 7 years, 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified -Other
|
6.9%
2/29 • Number of events 2 • 7 years, 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
27.6%
8/29 • Number of events 11 • 7 years, 6 months
|
|
Nervous system disorders
Akathisia
|
6.9%
2/29 • Number of events 5 • 7 years, 6 months
|
|
Nervous system disorders
Ataxia
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
Nervous system disorders
Concentration impairment
|
10.3%
3/29 • Number of events 3 • 7 years, 6 months
|
|
Nervous system disorders
Dizziness
|
34.5%
10/29 • Number of events 15 • 7 years, 6 months
|
|
Nervous system disorders
Dysgeusia
|
13.8%
4/29 • Number of events 5 • 7 years, 6 months
|
|
Nervous system disorders
Headache
|
24.1%
7/29 • Number of events 14 • 7 years, 6 months
|
|
Nervous system disorders
Memory impairment
|
6.9%
2/29 • Number of events 2 • 7 years, 6 months
|
|
Nervous system disorders
Movement, involuntary
|
31.0%
9/29 • Number of events 10 • 7 years, 6 months
|
|
Nervous system disorders
Nervous system disorders - Other
|
13.8%
4/29 • Number of events 4 • 7 years, 6 months
|
|
Nervous system disorders
Parasthesia
|
3.4%
1/29 • Number of events 2 • 7 years, 6 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
51.7%
15/29 • Number of events 21 • 7 years, 6 months
|
|
Nervous system disorders
Tremor
|
24.1%
7/29 • Number of events 7 • 7 years, 6 months
|
|
Psychiatric disorders
Agitation
|
20.7%
6/29 • Number of events 7 • 7 years, 6 months
|
|
Psychiatric disorders
Anxiety
|
6.9%
2/29 • Number of events 2 • 7 years, 6 months
|
|
Psychiatric disorders
Confusion
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
Psychiatric disorders
Depression
|
10.3%
3/29 • Number of events 4 • 7 years, 6 months
|
|
Psychiatric disorders
Insomnia
|
44.8%
13/29 • Number of events 13 • 7 years, 6 months
|
|
Psychiatric disorders
Personality change
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
Renal and urinary disorders
Acute kidney injury
|
6.9%
2/29 • Number of events 2 • 7 years, 6 months
|
|
Renal and urinary disorders
Hematuria
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
Renal and urinary disorders
Renal and urinary disorders - Other
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
Renal and urinary disorders
Urinary frequency
|
34.5%
10/29 • Number of events 11 • 7 years, 6 months
|
|
Renal and urinary disorders
Urinary incontinence
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
Renal and urinary disorders
Urinary urgency
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
27.6%
8/29 • Number of events 9 • 7 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
34.5%
10/29 • Number of events 18 • 7 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
44.8%
13/29 • Number of events 17 • 7 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.9%
2/29 • Number of events 2 • 7 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
6.9%
2/29 • Number of events 4 • 7 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
20.7%
6/29 • Number of events 6 • 7 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
17.2%
5/29 • Number of events 5 • 7 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Post nasal drip
|
6.9%
2/29 • Number of events 2 • 7 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
24.1%
7/29 • Number of events 8 • 7 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Reespiratory, thoracic and mediastinal disorders - Other
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
20.7%
6/29 • Number of events 6 • 7 years, 6 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.4%
1/29 • Number of events 2 • 7 years, 6 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
10.3%
3/29 • Number of events 4 • 7 years, 6 months
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
13.8%
4/29 • Number of events 4 • 7 years, 6 months
|
|
Skin and subcutaneous tissue disorders
Erythroderma
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
51.7%
15/29 • Number of events 16 • 7 years, 6 months
|
|
Skin and subcutaneous tissue disorders
Hypertrichosis
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
Skin and subcutaneous tissue disorders
Hypohidrosis
|
6.9%
2/29 • Number of events 2 • 7 years, 6 months
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
31.0%
9/29 • Number of events 12 • 7 years, 6 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
20.7%
6/29 • Number of events 11 • 7 years, 6 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
37.9%
11/29 • Number of events 16 • 7 years, 6 months
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
13.8%
4/29 • Number of events 4 • 7 years, 6 months
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
6.9%
2/29 • Number of events 2 • 7 years, 6 months
|
|
Surgical and medical procedures
Surgical and medical procedures - Other
|
13.8%
4/29 • Number of events 9 • 7 years, 6 months
|
|
Vascular disorders
Flushing
|
6.9%
2/29 • Number of events 2 • 7 years, 6 months
|
|
Vascular disorders
Hypertension
|
10.3%
3/29 • Number of events 8 • 7 years, 6 months
|
|
Vascular disorders
Hypotension
|
13.8%
4/29 • Number of events 4 • 7 years, 6 months
|
|
Vascular disorders
Vascular disorders - Other
|
3.4%
1/29 • Number of events 1 • 7 years, 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place