Trial Outcomes & Findings for Pomalidomide for Chronic Graft-versus-Host Disease (NCT NCT01688466)
NCT ID: NCT01688466
Last Updated: 2025-10-08
Results Overview
Overall response was assessed by the National Institutes of Health (NIH) Chronic Graft-Versus Host Disease (cGVHD) Response criteria. Complete response (CR) is complete resolution in all signs and symptoms at all affected organs or tissues. Partial response (PR) is improvement in ≥ 1 organ or tissue with no progression in any other affected organ or tissue. Response \< PR is a change towards improvement from the pre-treatment baseline but not meeting the criteria for CR or PR. Stable disease (SD) is no change in cGVHD. Flare is exacerbation of cGVHD manifestations during withdrawal of immunosuppressive therapy which do not exceed those at the beginning of the trial and improves after reinstatement of previous treatment. Progressive disease (PD) is failure of therapy to control cGVHD . Mixed response (improvement in some organs but worsening in others) will be categorized as progressive disease.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
34 participants
Primary outcome timeframe
6 months
Results posted on
2025-10-08
Participant Flow
Participant milestones
| Measure |
0.5 mg/Day With Dose Escalation
0.5 mg/day with Dose Escalation by 0.5 mg/day increments every 2 weeks to a maximum of 2.0 mg/day
Pomalidomide: 0.5 mg/day with and/or without Dose Escalation and 0.5 mg/day- 2.0 mg/day by mouth (PO) QD(every day) of each 28 day cycle
|
0.5 mg/Day Without Dose Escalation
0.5 mg/day without Dose Escalation
Pomalidomide: 0.5 mg/day with and/or without Dose Escalation and 0.5 mg/day- 2.0 mg/day by mouth (PO) QD(every day) of each 28 day cycle
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
17
|
|
Overall Study
COMPLETED
|
15
|
10
|
|
Overall Study
NOT COMPLETED
|
2
|
7
|
Reasons for withdrawal
| Measure |
0.5 mg/Day With Dose Escalation
0.5 mg/day with Dose Escalation by 0.5 mg/day increments every 2 weeks to a maximum of 2.0 mg/day
Pomalidomide: 0.5 mg/day with and/or without Dose Escalation and 0.5 mg/day- 2.0 mg/day by mouth (PO) QD(every day) of each 28 day cycle
|
0.5 mg/Day Without Dose Escalation
0.5 mg/day without Dose Escalation
Pomalidomide: 0.5 mg/day with and/or without Dose Escalation and 0.5 mg/day- 2.0 mg/day by mouth (PO) QD(every day) of each 28 day cycle
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Adverse Event
|
0
|
4
|
|
Overall Study
Not evaluable
|
0
|
1
|
Baseline Characteristics
Pomalidomide for Chronic Graft-versus-Host Disease
Baseline characteristics by cohort
| Measure |
0.5 mg/Day With Dose Escalation
n=17 Participants
0.5 mg/day with Dose Escalation by 0.5 mg/day increments every 2 weeks to a maximum of 2.0 mg/day
Pomalidomide: 0.5 mg/day with and/or without Dose Escalation and 0.5 mg/day- 2.0 mg/day by mouth (PO) QD(every day) of each 28 day cycle
|
0.5 mg/Day Without Dose Escalation
n=17 Participants
0.5 mg/day without Dose Escalation
Pomalidomide: 0.5 mg/day with and/or without Dose Escalation and 0.5 mg/day- 2.0 mg/day by mouth (PO) QD(every day) of each 28 day cycle
|
Total
n=34 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
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
48.5 years
STANDARD_DEVIATION 14.2 • n=5 Participants
|
46.8 years
STANDARD_DEVIATION 13.9 • n=7 Participants
|
47.65 years
STANDARD_DEVIATION 14.05 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mexican, Puerto Rican, Cuban, Central/So. American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not meeting definition for Hispanic or Latino
|
17 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsOverall response was assessed by the National Institutes of Health (NIH) Chronic Graft-Versus Host Disease (cGVHD) Response criteria. Complete response (CR) is complete resolution in all signs and symptoms at all affected organs or tissues. Partial response (PR) is improvement in ≥ 1 organ or tissue with no progression in any other affected organ or tissue. Response \< PR is a change towards improvement from the pre-treatment baseline but not meeting the criteria for CR or PR. Stable disease (SD) is no change in cGVHD. Flare is exacerbation of cGVHD manifestations during withdrawal of immunosuppressive therapy which do not exceed those at the beginning of the trial and improves after reinstatement of previous treatment. Progressive disease (PD) is failure of therapy to control cGVHD . Mixed response (improvement in some organs but worsening in others) will be categorized as progressive disease.
Outcome measures
| Measure |
0.5 mg/Day With Dose Escalation
n=17 Participants
0.5 mg/day with Dose Escalation by 0.5 mg/day increments every 2 weeks to a maximum of 2.0 mg/day
Pomalidomide: 0.5 mg/day with and/or without Dose Escalation and 0.5 mg/day- 2.0 mg/day by mouth (PO) QD(every day) of each 28 day cycle
|
0.5 mg/Day Without Dose Escalation
n=17 Participants
0.5 mg/day without Dose Escalation
Pomalidomide: 0.5 mg/day with and/or without Dose Escalation and 0.5 mg/day- 2.0 mg/day by mouth (PO) QD(every day) of each 28 day cycle
|
|---|---|---|
|
Overall Response at 6 Months
Progressive Disease
|
2 Participants
|
5 Participants
|
|
Overall Response at 6 Months
Complete Response
|
0 Participants
|
0 Participants
|
|
Overall Response at 6 Months
Partial Response
|
7 Participants
|
9 Participants
|
|
Overall Response at 6 Months
Stable Disease
|
0 Participants
|
1 Participants
|
|
Overall Response at 6 Months
Mixed Response
|
0 Participants
|
0 Participants
|
|
Overall Response at 6 Months
Response < Partial Response
|
0 Participants
|
0 Participants
|
|
Overall Response at 6 Months
Flare
|
0 Participants
|
0 Participants
|
|
Overall Response at 6 Months
Did not respond to treatment
|
1 Participants
|
0 Participants
|
|
Overall Response at 6 Months
Not Evaluable
|
7 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 50 months and 20 daysHere is the count of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE) v4.0. A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Outcome measures
| Measure |
0.5 mg/Day With Dose Escalation
n=17 Participants
0.5 mg/day with Dose Escalation by 0.5 mg/day increments every 2 weeks to a maximum of 2.0 mg/day
Pomalidomide: 0.5 mg/day with and/or without Dose Escalation and 0.5 mg/day- 2.0 mg/day by mouth (PO) QD(every day) of each 28 day cycle
|
0.5 mg/Day Without Dose Escalation
n=17 Participants
0.5 mg/day without Dose Escalation
Pomalidomide: 0.5 mg/day with and/or without Dose Escalation and 0.5 mg/day- 2.0 mg/day by mouth (PO) QD(every day) of each 28 day cycle
|
|---|---|---|
|
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE) v4.0
|
17 Participants
|
17 Participants
|
Adverse Events
0.5 mg/Day With Dose Escalation
Serious events: 11 serious events
Other events: 17 other events
Deaths: 0 deaths
0.5 mg/Day Without Dose Escalation
Serious events: 8 serious events
Other events: 17 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
0.5 mg/Day With Dose Escalation
n=17 participants at risk
0.5 mg/day with Dose Escalation by 0.5 mg/day increments every 2 weeks to a maximum of 2.0 mg/day
Pomalidomide: 0.5 mg/day with and/or without Dose Escalation and 0.5 mg/day- 2.0 mg/day by mouth (PO) QD(every day) of each 28 day cycle
|
0.5 mg/Day Without Dose Escalation
n=17 participants at risk
0.5 mg/day without Dose Escalation
Pomalidomide: 0.5 mg/day with and/or without Dose Escalation and 0.5 mg/day- 2.0 mg/day by mouth (PO) QD(every day) of each 28 day cycle
|
|---|---|---|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/17 • 50 months and 20 days
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
|
Investigations
Alanine aminotransferase increased
|
5.9%
1/17 • Number of events 2 • 50 months and 20 days
|
0.00%
0/17 • 50 months and 20 days
|
|
Investigations
Alkaline phosphatase increased
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
0.00%
0/17 • 50 months and 20 days
|
|
Blood and lymphatic system disorders
Anemia
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
0.00%
0/17 • 50 months and 20 days
|
|
Investigations
Aspartate aminotransferase increased
|
5.9%
1/17 • Number of events 2 • 50 months and 20 days
|
0.00%
0/17 • 50 months and 20 days
|
|
Infections and infestations
Bronchial infection
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
|
Investigations
Carbon monoxide diffusing capacity decreased
|
11.8%
2/17 • Number of events 2 • 50 months and 20 days
|
0.00%
0/17 • 50 months and 20 days
|
|
Cardiac disorders
Chest pain - cardiac
|
0.00%
0/17 • 50 months and 20 days
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/17 • 50 months and 20 days
|
11.8%
2/17 • Number of events 2 • 50 months and 20 days
|
|
Gastrointestinal disorders
Duodenal ulcer
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
0.00%
0/17 • 50 months and 20 days
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/17 • 50 months and 20 days
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
|
General disorders
Fever
|
0.00%
0/17 • 50 months and 20 days
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
0.00%
0/17 • 50 months and 20 days
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
0.00%
0/17 • 50 months and 20 days
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
0.00%
0/17 • 50 months and 20 days
|
|
Vascular disorders
Hypotension
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
11.8%
2/17 • Number of events 3 • 50 months and 20 days
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
|
Infections and infestations
Infections and infestations - Other, specify
|
0.00%
0/17 • 50 months and 20 days
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
|
Infections and infestations
Lung infection
|
11.8%
2/17 • Number of events 2 • 50 months and 20 days
|
29.4%
5/17 • Number of events 6 • 50 months and 20 days
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/17 • 50 months and 20 days
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
|
Investigations
Neutrophil count decreased
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
0.00%
0/17 • 50 months and 20 days
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/17 • 50 months and 20 days
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
|
Eye disorders
Retinopathy
|
0.00%
0/17 • 50 months and 20 days
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
|
Infections and infestations
Salivary gland infection
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
0.00%
0/17 • 50 months and 20 days
|
|
Infections and infestations
Sepsis
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
0.00%
0/17 • 50 months and 20 days
|
|
Cardiac disorders
Sinus bradycardia
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
0.00%
0/17 • 50 months and 20 days
|
|
Infections and infestations
Skin infection
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
11.8%
2/17 • Number of events 4 • 50 months and 20 days
|
|
Nervous system disorders
Syncope
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
0.00%
0/17 • 50 months and 20 days
|
|
Vascular disorders
Thromboembolic event
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
0.00%
0/17 • 50 months and 20 days
|
|
Infections and infestations
Wound infection
|
0.00%
0/17 • 50 months and 20 days
|
11.8%
2/17 • Number of events 2 • 50 months and 20 days
|
Other adverse events
| Measure |
0.5 mg/Day With Dose Escalation
n=17 participants at risk
0.5 mg/day with Dose Escalation by 0.5 mg/day increments every 2 weeks to a maximum of 2.0 mg/day
Pomalidomide: 0.5 mg/day with and/or without Dose Escalation and 0.5 mg/day- 2.0 mg/day by mouth (PO) QD(every day) of each 28 day cycle
|
0.5 mg/Day Without Dose Escalation
n=17 participants at risk
0.5 mg/day without Dose Escalation
Pomalidomide: 0.5 mg/day with and/or without Dose Escalation and 0.5 mg/day- 2.0 mg/day by mouth (PO) QD(every day) of each 28 day cycle
|
|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
11.8%
2/17 • Number of events 2 • 50 months and 20 days
|
5.9%
1/17 • Number of events 2 • 50 months and 20 days
|
|
Nervous system disorders
Amnesia
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
0.00%
0/17 • 50 months and 20 days
|
|
Blood and lymphatic system disorders
Anemia
|
11.8%
2/17 • Number of events 3 • 50 months and 20 days
|
17.6%
3/17 • Number of events 4 • 50 months and 20 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.8%
2/17 • Number of events 2 • 50 months and 20 days
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/17 • 50 months and 20 days
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/17 • 50 months and 20 days
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
|
Eye disorders
Blurred vision
|
11.8%
2/17 • Number of events 2 • 50 months and 20 days
|
11.8%
2/17 • Number of events 2 • 50 months and 20 days
|
|
Infections and infestations
Bronchial infection
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
0.00%
0/17 • 50 months and 20 days
|
|
Skin and subcutaneous tissue disorders
Bullous dermatitis
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
11.8%
2/17 • Number of events 2 • 50 months and 20 days
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
0.00%
0/17 • 50 months and 20 days
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
|
Gastrointestinal disorders
Constipation
|
11.8%
2/17 • Number of events 2 • 50 months and 20 days
|
0.00%
0/17 • 50 months and 20 days
|
|
Investigations
Creatinine increased
|
0.00%
0/17 • 50 months and 20 days
|
17.6%
3/17 • Number of events 3 • 50 months and 20 days
|
|
Psychiatric disorders
Depression
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
0.00%
0/17 • 50 months and 20 days
|
|
Gastrointestinal disorders
Diarrhea
|
23.5%
4/17 • Number of events 4 • 50 months and 20 days
|
11.8%
2/17 • Number of events 2 • 50 months and 20 days
|
|
Nervous system disorders
Dizziness
|
11.8%
2/17 • Number of events 2 • 50 months and 20 days
|
11.8%
2/17 • Number of events 2 • 50 months and 20 days
|
|
Eye disorders
Dry eye
|
11.8%
2/17 • Number of events 2 • 50 months and 20 days
|
11.8%
2/17 • Number of events 2 • 50 months and 20 days
|
|
Gastrointestinal disorders
Dry mouth
|
11.8%
2/17 • Number of events 2 • 50 months and 20 days
|
0.00%
0/17 • 50 months and 20 days
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
0.00%
0/17 • 50 months and 20 days
|
|
Nervous system disorders
Dysesthesia
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
0.00%
0/17 • 50 months and 20 days
|
|
Nervous system disorders
Dysphasia
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
0.00%
0/17 • 50 months and 20 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
11.8%
2/17 • Number of events 2 • 50 months and 20 days
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
|
General disorders
Edema limbs
|
17.6%
3/17 • Number of events 3 • 50 months and 20 days
|
23.5%
4/17 • Number of events 4 • 50 months and 20 days
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/17 • 50 months and 20 days
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
|
Gastrointestinal disorders
Esophageal ulcer
|
0.00%
0/17 • 50 months and 20 days
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
|
General disorders
Fatigue
|
58.8%
10/17 • Number of events 11 • 50 months and 20 days
|
17.6%
3/17 • Number of events 3 • 50 months and 20 days
|
|
General disorders
Flu like symptoms
|
0.00%
0/17 • 50 months and 20 days
|
11.8%
2/17 • Number of events 2 • 50 months and 20 days
|
|
Respiratory, thoracic and mediastinal disorders
Forced expiratory volume decreased
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
11.8%
2/17 • Number of events 2 • 50 months and 20 days
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
11.8%
2/17 • Number of events 2 • 50 months and 20 days
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
0.00%
0/17 • 50 months and 20 days
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
0.00%
0/17 • 50 months and 20 days
|
|
Eye disorders
Glaucoma
|
0.00%
0/17 • 50 months and 20 days
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
|
Nervous system disorders
Headache
|
0.00%
0/17 • 50 months and 20 days
|
11.8%
2/17 • Number of events 2 • 50 months and 20 days
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/17 • 50 months and 20 days
|
11.8%
2/17 • Number of events 2 • 50 months and 20 days
|
|
Blood and lymphatic system disorders
Hemolysis
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
0.00%
0/17 • 50 months and 20 days
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
11.8%
2/17 • Number of events 4 • 50 months and 20 days
|
0.00%
0/17 • 50 months and 20 days
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
0.00%
0/17 • 50 months and 20 days
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
11.8%
2/17 • Number of events 2 • 50 months and 20 days
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/17 • 50 months and 20 days
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
|
Vascular disorders
Hypertension
|
11.8%
2/17 • Number of events 2 • 50 months and 20 days
|
17.6%
3/17 • Number of events 3 • 50 months and 20 days
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/17 • 50 months and 20 days
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
11.8%
2/17 • Number of events 2 • 50 months and 20 days
|
17.6%
3/17 • Number of events 3 • 50 months and 20 days
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/17 • 50 months and 20 days
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
0.00%
0/17 • 50 months and 20 days
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
52.9%
9/17 • Number of events 10 • 50 months and 20 days
|
23.5%
4/17 • Number of events 5 • 50 months and 20 days
|
|
Vascular disorders
Hypotension
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
|
Immune system disorders
Immune system disorders - Other, specify
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
0.00%
0/17 • 50 months and 20 days
|
|
Infections and infestations
Infections and infestations - Other, specify
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
0.00%
0/17 • 50 months and 20 days
|
|
Psychiatric disorders
Insomnia
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased cervical spine
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
0.00%
0/17 • 50 months and 20 days
|
|
Infections and infestations
Lung infection
|
23.5%
4/17 • Number of events 5 • 50 months and 20 days
|
17.6%
3/17 • Number of events 3 • 50 months and 20 days
|
|
Investigations
Lymphocyte count decreased
|
58.8%
10/17 • Number of events 14 • 50 months and 20 days
|
47.1%
8/17 • Number of events 9 • 50 months and 20 days
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/17 • 50 months and 20 days
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
|
Nervous system disorders
Memory impairment
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
|
Gastrointestinal disorders
Mucositis oral
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
0.00%
0/17 • 50 months and 20 days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
0.00%
0/17 • 50 months and 20 days
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
23.5%
4/17 • Number of events 4 • 50 months and 20 days
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/17 • 50 months and 20 days
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
|
Gastrointestinal disorders
Nausea
|
17.6%
3/17 • Number of events 3 • 50 months and 20 days
|
11.8%
2/17 • Number of events 2 • 50 months and 20 days
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
0.00%
0/17 • 50 months and 20 days
|
|
Investigations
Neutrophil count decreased
|
35.3%
6/17 • Number of events 8 • 50 months and 20 days
|
11.8%
2/17 • Number of events 2 • 50 months and 20 days
|
|
Musculoskeletal and connective tissue disorders
Non-cardiac chest pain
|
0.00%
0/17 • 50 months and 20 days
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
|
Gastrointestinal disorders
Oral pain
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
0.00%
0/17 • 50 months and 20 days
|
|
General disorders
Pain
|
0.00%
0/17 • 50 months and 20 days
|
5.9%
1/17 • Number of events 2 • 50 months and 20 days
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.8%
2/17 • Number of events 2 • 50 months and 20 days
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/17 • 50 months and 20 days
|
17.6%
3/17 • Number of events 5 • 50 months and 20 days
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
|
Eye disorders
Photophobia
|
0.00%
0/17 • 50 months and 20 days
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/17 • 50 months and 20 days
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
29.4%
5/17 • Number of events 5 • 50 months and 20 days
|
29.4%
5/17 • Number of events 7 • 50 months and 20 days
|
|
Eye disorders
Retinal vascular disorder
|
0.00%
0/17 • 50 months and 20 days
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
|
Cardiac disorders
Sinus bradycardia
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
0.00%
0/17 • 50 months and 20 days
|
|
Cardiac disorders
Sinus tachycardia
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
0.00%
0/17 • 50 months and 20 days
|
|
Infections and infestations
Sinusitis
|
17.6%
3/17 • Number of events 3 • 50 months and 20 days
|
0.00%
0/17 • 50 months and 20 days
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
0.00%
0/17 • 50 months and 20 days
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
|
Infections and infestations
Skin infection
|
5.9%
1/17 • Number of events 4 • 50 months and 20 days
|
11.8%
2/17 • Number of events 2 • 50 months and 20 days
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
17.6%
3/17 • Number of events 5 • 50 months and 20 days
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/17 • 50 months and 20 days
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
|
Nervous system disorders
Syncope
|
0.00%
0/17 • 50 months and 20 days
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
|
Reproductive system and breast disorders
Testicular pain
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
0.00%
0/17 • 50 months and 20 days
|
|
Gastrointestinal disorders
Toothache
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
0.00%
0/17 • 50 months and 20 days
|
|
Nervous system disorders
Tremor
|
29.4%
5/17 • Number of events 5 • 50 months and 20 days
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
41.2%
7/17 • Number of events 7 • 50 months and 20 days
|
52.9%
9/17 • Number of events 14 • 50 months and 20 days
|
|
Renal and urinary disorders
Urinary frequency
|
11.8%
2/17 • Number of events 2 • 50 months and 20 days
|
0.00%
0/17 • 50 months and 20 days
|
|
Infections and infestations
Urinary tract infection
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
0.00%
0/17 • 50 months and 20 days
|
|
Reproductive system and breast disorders
Vaginal inflammation
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
0.00%
0/17 • 50 months and 20 days
|
|
Gastrointestinal disorders
Vomiting
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
|
Investigations
Weight loss
|
5.9%
1/17 • Number of events 1 • 50 months and 20 days
|
0.00%
0/17 • 50 months and 20 days
|
|
Investigations
White blood cell decreased
|
11.8%
2/17 • Number of events 3 • 50 months and 20 days
|
11.8%
2/17 • Number of events 2 • 50 months and 20 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place