Trial Outcomes & Findings for Ibrutinib in Combination With GA101 (Obinutuzumab) in Previously Untreated Chronic Lymphocytic Leukemia (CLL) Patients. (NCT NCT02315768)
NCT ID: NCT02315768
Last Updated: 2025-09-15
Results Overview
Remission rate after discontinuation of Ibrutinib in patients with previously untreated CLL treated with Ibrutinib in combination with Obinutuzumab
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
32 participants
Primary outcome timeframe
4 weeks
Results posted on
2025-09-15
Participant Flow
Participant milestones
| Measure |
GA101+Ibrutinib
Ibrutinib 420 mg (140 mg capsules 3 times) orally once daily for up to 6 cycles.
GA101 (Obinutuzumab) by Intravenous infusion for up to 6 cycles (28 day cycles) as follows:
* Cycle 1, Day 1,100 mg GA101 obinutuzumab will be administered.
* Cycle 1, Day 2, 900 mg of GA101 obinutuzumab will be administered.
* Cycle 1, Days 8 and 15,1,000 mg of GA101 obinutuzumab will be administered.
* Cycles 2-6, Day 1, 1,000 mg of GA101 obinutuzumab will be administered.
GA101
ibrutinib
|
|---|---|
|
Overall Study
STARTED
|
32
|
|
Overall Study
COMPLETED
|
32
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ibrutinib in Combination With GA101 (Obinutuzumab) in Previously Untreated Chronic Lymphocytic Leukemia (CLL) Patients.
Baseline characteristics by cohort
| Measure |
GA101+Ibrutinib
n=32 Participants
Ibrutinib 420 mg (140 mg capsules 3 times) orally once daily for up to 6 cycles.
GA101 (Obinutuzumab) by Intravenous infusion for up to 6 cycles (28 day cycles) as follows:
* Cycle 1, Day 1,100 mg GA101 obinutuzumab will be administered.
* Cycle 1, Day 2, 900 mg of GA101 obinutuzumab will be administered.
* Cycle 1, Days 8 and 15,1,000 mg of GA101 obinutuzumab will be administered.
* Cycles 2-6, Day 1, 1,000 mg of GA101 obinutuzumab will be administered.
GA101
ibrutinib
|
|---|---|
|
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
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 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
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 weeksRemission rate after discontinuation of Ibrutinib in patients with previously untreated CLL treated with Ibrutinib in combination with Obinutuzumab
Outcome measures
| Measure |
GA101+Ibrutinib
n=32 Participants
Ibrutinib 420 mg (140 mg capsules 3 times) orally once daily for up to 6 cycles.
GA101 (Obinutuzumab) by Intravenous infusion for up to 6 cycles (28 day cycles) as follows:
* Cycle 1, Day 1,100 mg GA101 obinutuzumab will be administered.
* Cycle 1, Day 2, 900 mg of GA101 obinutuzumab will be administered.
* Cycle 1, Days 8 and 15,1,000 mg of GA101 obinutuzumab will be administered.
* Cycles 2-6, Day 1, 1,000 mg of GA101 obinutuzumab will be administered.
GA101
ibrutinib
|
|---|---|
|
Safety, Tolerability and Dose Limiting Toxicity (DLT) of Ibrutinib in Combination With Obinutuzumab
|
32 Participants
|
PRIMARY outcome
Timeframe: 2 yearsDetermine the overall response rate of Ibrutinib in combination with Obinutuzumab in previously untreated subjects with CLL. Overall response rate was based on the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2008 criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
GA101+Ibrutinib
n=32 Participants
Ibrutinib 420 mg (140 mg capsules 3 times) orally once daily for up to 6 cycles.
GA101 (Obinutuzumab) by Intravenous infusion for up to 6 cycles (28 day cycles) as follows:
* Cycle 1, Day 1,100 mg GA101 obinutuzumab will be administered.
* Cycle 1, Day 2, 900 mg of GA101 obinutuzumab will be administered.
* Cycle 1, Days 8 and 15,1,000 mg of GA101 obinutuzumab will be administered.
* Cycles 2-6, Day 1, 1,000 mg of GA101 obinutuzumab will be administered.
GA101
ibrutinib
|
|---|---|
|
Overall Response Rate of Ibrutinib in Combination With Obinutuzumab
|
32 Participants
|
Adverse Events
GA101+Ibrutinib
Serious events: 3 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GA101+Ibrutinib
n=32 participants at risk
Ibrutinib 420 mg (140 mg capsules 3 times) orally once daily for up to 6 cycles.
GA101 (Obinutuzumab) by Intravenous infusion for up to 6 cycles (28 day cycles) as follows:
* Cycle 1, Day 1,100 mg GA101 obinutuzumab will be administered.
* Cycle 1, Day 2, 900 mg of GA101 obinutuzumab will be administered.
* Cycle 1, Days 8 and 15,1,000 mg of GA101 obinutuzumab will be administered.
* Cycles 2-6, Day 1, 1,000 mg of GA101 obinutuzumab will be administered.
GA101
ibrutinib
|
|---|---|
|
Infections and infestations
Fever/Sepsis (IRR)
|
3.1%
1/32 • Number of events 1 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
6.2%
2/32 • Number of events 3 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
General disorders
SAE
|
9.4%
3/32 • Number of events 3 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
Other adverse events
| Measure |
GA101+Ibrutinib
n=32 participants at risk
Ibrutinib 420 mg (140 mg capsules 3 times) orally once daily for up to 6 cycles.
GA101 (Obinutuzumab) by Intravenous infusion for up to 6 cycles (28 day cycles) as follows:
* Cycle 1, Day 1,100 mg GA101 obinutuzumab will be administered.
* Cycle 1, Day 2, 900 mg of GA101 obinutuzumab will be administered.
* Cycle 1, Days 8 and 15,1,000 mg of GA101 obinutuzumab will be administered.
* Cycles 2-6, Day 1, 1,000 mg of GA101 obinutuzumab will be administered.
GA101
ibrutinib
|
|---|---|
|
Gastrointestinal disorders
Abdominal cramping
|
3.1%
1/32 • Number of events 1 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Gastrointestinal disorders
Abdominal distension
|
6.2%
2/32 • Number of events 2 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.1%
1/32 • Number of events 1 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
General disorders
Albumin decreased
|
3.1%
1/32 • Number of events 1 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Hepatobiliary disorders
Alkaline Phosphatasee Increase
|
6.2%
2/32 • Number of events 6 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Hepatobiliary disorders
ALT elevated
|
34.4%
11/32 • Number of events 19 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Blood and lymphatic system disorders
Anemia
|
18.8%
6/32 • Number of events 12 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Metabolism and nutrition disorders
Anorexia
|
3.1%
1/32 • Number of events 1 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Cardiac disorders
Arrhythmia
|
3.1%
1/32 • Number of events 1 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
15.6%
5/32 • Number of events 5 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
3.1%
1/32 • Number of events 1 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Hepatobiliary disorders
AST elevated
|
34.4%
11/32 • Number of events 16 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Cardiac disorders
Atrial fibrillation
|
9.4%
3/32 • Number of events 6 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Musculoskeletal and connective tissue disorders
Back and neck pain
|
3.1%
1/32 • Number of events 1 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.2%
2/32 • Number of events 3 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bleeding from auditory cancer
|
3.1%
1/32 • Number of events 1 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Gastrointestinal disorders
Bloating
|
3.1%
1/32 • Number of events 1 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Hepatobiliary disorders
Blood bilirubin increased
|
18.8%
6/32 • Number of events 16 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Skin and subcutaneous tissue disorders
Brittle nails
|
12.5%
4/32 • Number of events 4 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Vascular disorders
Bruising
|
21.9%
7/32 • Number of events 8 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
6.2%
2/32 • Number of events 2 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Respiratory, thoracic and mediastinal disorders
Chest congestion
|
3.1%
1/32 • Number of events 1 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
General disorders
Chills
|
3.1%
1/32 • Number of events 1 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic cough
|
3.1%
1/32 • Number of events 1 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
8/32 • Number of events 9 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Renal and urinary disorders
Creatinine increased
|
15.6%
5/32 • Number of events 14 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Gastrointestinal disorders
Diarrhea
|
46.9%
15/32 • Number of events 23 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
General disorders
Dry Mouth
|
3.1%
1/32 • Number of events 1 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
3.1%
1/32 • Number of events 1 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.2%
2/32 • Number of events 2 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Ear and labyrinth disorders
Ear bleeding
|
3.1%
1/32 • Number of events 1 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Ear and labyrinth disorders
Ear infection
|
3.1%
1/32 • Number of events 1 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Vascular disorders
edema
|
6.2%
2/32 • Number of events 2 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Hepatobiliary disorders
Elevated AST
|
31.2%
10/32 • Number of events 12 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Hepatobiliary disorders
Elevated Bilirubin
|
3.1%
1/32 • Number of events 1 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Renal and urinary disorders
Elevated creatinine
|
15.6%
5/32 • Number of events 8 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Renal and urinary disorders
Elevated Phosphorus
|
3.1%
1/32 • Number of events 1 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Renal and urinary disorders
Elevated uric acid
|
3.1%
1/32 • Number of events 1 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
General disorders
Epistaxis
|
9.4%
3/32 • Number of events 3 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Eye disorders
Eye Infection
|
3.1%
1/32 • Number of events 1 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Skin and subcutaneous tissue disorders
Facial bruise
|
3.1%
1/32 • Number of events 1 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
General disorders
Fatigue
|
15.6%
5/32 • Number of events 7 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
General disorders
Fever
|
6.2%
2/32 • Number of events 3 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Skin and subcutaneous tissue disorders
Finger Nail Fragility
|
3.1%
1/32 • Number of events 1 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
General disorders
Flu-like symptoms
|
6.2%
2/32 • Number of events 4 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Skin and subcutaneous tissue disorders
Fragile Nails
|
6.2%
2/32 • Number of events 2 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Gastrointestinal disorders
Gastro-intestinal bleed
|
3.1%
1/32 • Number of events 1 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Gastrointestinal disorders
GERD
|
3.1%
1/32 • Number of events 1 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Skin and subcutaneous tissue disorders
Hair Loss
|
3.1%
1/32 • Number of events 1 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Immune system disorders
Hand inflammation
|
3.1%
1/32 • Number of events 1 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Skin and subcutaneous tissue disorders
Hand lesion
|
3.1%
1/32 • Number of events 1 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
General disorders
Headache
|
18.8%
6/32 • Number of events 9 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Cardiac disorders
Heart palpitations
|
3.1%
1/32 • Number of events 2 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Gastrointestinal disorders
Heartburn
|
3.1%
1/32 • Number of events 1 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Gastrointestinal disorders
Hematochezia
|
3.1%
1/32 • Number of events 1 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Renal and urinary disorders
Hematuria
|
9.4%
3/32 • Number of events 3 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Hepatobiliary disorders
Hyperbilirubinemia
|
9.4%
3/32 • Number of events 11 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
34.4%
11/32 • Number of events 39 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Renal and urinary disorders
Hyperkalemia
|
25.0%
8/32 • Number of events 14 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Renal and urinary disorders
Hypernatremia
|
3.1%
1/32 • Number of events 1 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Renal and urinary disorders
Hyperphosphatemia
|
34.4%
11/32 • Number of events 22 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Cardiac disorders
Hypertension
|
21.9%
7/32 • Number of events 9 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Renal and urinary disorders
Hyperuricema
|
25.0%
8/32 • Number of events 16 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Blood and lymphatic system disorders
Hypoalbuminemia
|
12.5%
4/32 • Number of events 4 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Renal and urinary disorders
Hypocalcemia
|
12.5%
4/32 • Number of events 4 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
12.5%
4/32 • Number of events 8 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Renal and urinary disorders
Hypokalemia
|
9.4%
3/32 • Number of events 4 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Renal and urinary disorders
Hyponatremia
|
9.4%
3/32 • Number of events 7 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Renal and urinary disorders
Hypophosphatemia
|
28.1%
9/32 • Number of events 13 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Cardiac disorders
Hypoxia
|
3.1%
1/32 • Number of events 1 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Infections and infestations
Infected nose ulcer
|
3.1%
1/32 • Number of events 1 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Immune system disorders
Infusion reaction
|
3.1%
1/32 • Number of events 1 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Immune system disorders
Infusion-related reaction
|
3.1%
1/32 • Number of events 1 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Skin and subcutaneous tissue disorders
Itching
|
6.2%
2/32 • Number of events 2 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Musculoskeletal and connective tissue disorders
Jaw discomfort
|
3.1%
1/32 • Number of events 1 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
15.6%
5/32 • Number of events 5 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
General disorders
Light-headedness
|
3.1%
1/32 • Number of events 1 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Blood and lymphatic system disorders
Lymphocyte count increased
|
3.1%
1/32 • Number of events 1 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Vascular disorders
Mild bruising
|
3.1%
1/32 • Number of events 1 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Skin and subcutaneous tissue disorders
Mouth sores
|
6.2%
2/32 • Number of events 3 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Musculoskeletal and connective tissue disorders
Muscle cramps
|
18.8%
6/32 • Number of events 7 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Musculoskeletal and connective tissue disorders
Muscle soreness
|
15.6%
5/32 • Number of events 5 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
3.1%
1/32 • Number of events 2 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.1%
1/32 • Number of events 1 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Skin and subcutaneous tissue disorders
Nail Fragility
|
9.4%
3/32 • Number of events 3 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Gastrointestinal disorders
Nausea
|
15.6%
5/32 • Number of events 6 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Blood and lymphatic system disorders
Neutropenia
|
56.2%
18/32 • Number of events 83 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
General disorders
Nose bleed
|
9.4%
3/32 • Number of events 4 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Nervous system disorders
Paresthesia
|
3.1%
1/32 • Number of events 1 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Infections and infestations
Paronychia in right toe
|
3.1%
1/32 • Number of events 2 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Vascular disorders
Petechia
|
3.1%
1/32 • Number of events 1 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
12.5%
4/32 • Number of events 5 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.1%
1/32 • Number of events 2 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
3.1%
1/32 • Number of events 1 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate CA
|
3.1%
1/32 • Number of events 1 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Cardiac disorders
Rapid heart rate
|
3.1%
1/32 • Number of events 3 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Skin and subcutaneous tissue disorders
Rash
|
34.4%
11/32 • Number of events 16 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Musculoskeletal and connective tissue disorders
Rib pain (bruise)
|
6.2%
2/32 • Number of events 3 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Skin and subcutaneous tissue disorders
Scalp inflammation
|
3.1%
1/32 • Number of events 1 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Infections and infestations
Shingles
|
3.1%
1/32 • Number of events 1 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus tachycardia
|
3.1%
1/32 • Number of events 1 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
6.2%
2/32 • Number of events 2 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Skin and subcutaneous tissue disorders
Skin lesions
|
3.1%
1/32 • Number of events 2 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
3.1%
1/32 • Number of events 1 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Gastrointestinal disorders
Stomach pain (left side)
|
3.1%
1/32 • Number of events 1 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnea
|
3.1%
1/32 • Number of events 1 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
71.9%
23/32 • Number of events 128 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
6.2%
2/32 • Number of events 3 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Renal and urinary disorders
UTI
|
3.1%
1/32 • Number of events 1 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Eye disorders
Visual Change
|
3.1%
1/32 • Number of events 1 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Gastrointestinal disorders
Vomiting
|
9.4%
3/32 • Number of events 3 • 3 years
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place