Trial Outcomes & Findings for Pilot Study of Radiation-Enhanced Allogeneic Cell Therapy for Progressive Hematologic Malignancy After Allogeneic Hematopoietic Stem Cell Transplantation (NCT NCT00984165)
NCT ID: NCT00984165
Last Updated: 2018-05-02
Results Overview
The following criteria is used to determine response to GVHD treatment. Complete response (CR) is complete resolution of all clinical signs and symptoms of acute GVHD. Partial response (PR) is 50% reduction in skin rash, stool volume or frequency, and/or total bilirubin. Failure to maintain adequate performance status (Karnofsky Score \>/= 70%). Non-responder (NR) \<50% reduction in skin rash, stool volume or frequency, and/or total bilirubin. Failure to maintain adequate performance status (Karnofsky Score \</= 70%). Progressive disease (PD) is further progression of signs and symptoms of acute GVHD, and/or decline in performance status after the initiation of therapy.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
Up to 100 days
Results posted on
2018-05-02
Participant Flow
Participant milestones
| Measure |
Donor Lymphocyte Infusion/Radiation
Subjects will receive a unmanipulated donor lymphocyte infusion (DLI) on Day 1 after radiation (single, 8-Gy fraction to the maximum number of lesions).
|
Radiation/No Donor Lymphocyte Infusion
Subjects will receive radiation (single, 8-Gy fraction to the maximum number of lesions).
|
Donor Lymphocyte Infusion - Control
Subjects will receive a unmanipulated donor lymphocyte infusion (DLI) on Day 0.
|
Donor Lymphocyte Infusion - Donor
Healthy subjects who donated lymphocytes for infusion on a treatment Arm.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
1
|
4
|
4
|
|
Overall Study
COMPLETED
|
2
|
0
|
4
|
0
|
|
Overall Study
NOT COMPLETED
|
7
|
1
|
0
|
4
|
Reasons for withdrawal
| Measure |
Donor Lymphocyte Infusion/Radiation
Subjects will receive a unmanipulated donor lymphocyte infusion (DLI) on Day 1 after radiation (single, 8-Gy fraction to the maximum number of lesions).
|
Radiation/No Donor Lymphocyte Infusion
Subjects will receive radiation (single, 8-Gy fraction to the maximum number of lesions).
|
Donor Lymphocyte Infusion - Control
Subjects will receive a unmanipulated donor lymphocyte infusion (DLI) on Day 0.
|
Donor Lymphocyte Infusion - Donor
Healthy subjects who donated lymphocytes for infusion on a treatment Arm.
|
|---|---|---|---|---|
|
Overall Study
Death on study
|
2
|
0
|
0
|
0
|
|
Overall Study
Disease progression on study
|
5
|
1
|
0
|
0
|
|
Overall Study
Death of recipient
|
0
|
0
|
0
|
1
|
|
Overall Study
New protocol
|
0
|
0
|
0
|
1
|
|
Overall Study
P+/donor pair removed from protocol
|
0
|
0
|
0
|
1
|
|
Overall Study
removed with a pair recipient
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Pilot Study of Radiation-Enhanced Allogeneic Cell Therapy for Progressive Hematologic Malignancy After Allogeneic Hematopoietic Stem Cell Transplantation
Baseline characteristics by cohort
| Measure |
Donor Lymphocyte Infusion/Radiation
n=9 Participants
Subjects will receive a unmanipulated donor lymphocyte infusion (DLI) on Day 1 after radiation (single, 8-Gy fraction to the maximum number of lesions).
|
Radiation/No Donor Lymphocyte Infusion
n=1 Participants
Subjects will receive radiation (single, 8-Gy fraction to the maximum number of lesions).
|
Donor Lymphocyte Infusion - Control
n=4 Participants
Subjects will receive a unmanipulated donor lymphocyte infusion (DLI) on Day 0.
|
Donor Lymphocyte Infusion - Donor
n=4 Participants
Healthy subjects who donated lymphocytes for infusion on a treatment Arm.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
17 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Age, Continuous
|
46.78 years
STANDARD_DEVIATION 14.84 • n=99 Participants
|
33.5 years
STANDARD_DEVIATION 0 • n=107 Participants
|
29.5 years
STANDARD_DEVIATION 3.41 • n=206 Participants
|
34.83 years
STANDARD_DEVIATION 3.97 • n=7 Participants
|
36.15 years
STANDARD_DEVIATION 0.01 • n=31 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
10 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
17 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
18 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
9 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
18 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Up to 100 daysPopulation: No results were collected on the Donor Lymphocyte Infusion-Donor "Arm". This arm allowed for collection of the lymphocytes on healthy donors for infusion on the DLI/Radiation Arm or the DLI/Control Group.
The following criteria is used to determine response to GVHD treatment. Complete response (CR) is complete resolution of all clinical signs and symptoms of acute GVHD. Partial response (PR) is 50% reduction in skin rash, stool volume or frequency, and/or total bilirubin. Failure to maintain adequate performance status (Karnofsky Score \>/= 70%). Non-responder (NR) \<50% reduction in skin rash, stool volume or frequency, and/or total bilirubin. Failure to maintain adequate performance status (Karnofsky Score \</= 70%). Progressive disease (PD) is further progression of signs and symptoms of acute GVHD, and/or decline in performance status after the initiation of therapy.
Outcome measures
| Measure |
Donor Lymphocyte Infusion/Radiation
n=9 Participants
Subjects will receive a unmanipulated donor lymphocyte infusion (DLI) on Day 1 after radiation (single, 8-Gy fraction to the maximum number of lesions).
|
Radiation/No Donor Lymphocyte Infusion
n=1 Participants
Subjects will receive radiation (single, 8-Gy fraction to the maximum number of lesions).
|
Donor Lymphocyte Infusion-Control
n=4 Participants
Subjects will receive a unmanipulated donor lymphocyte infusion (DLI) on Day 0.
|
Donor Lymphocyte Infusion - Donor
Healthy subjects who donated lymphocytes for infusion on a treatment Arm.
|
|---|---|---|---|---|
|
Response to Graft Versus Host Disease (GVHD) Treatment
Complete Response (CR)
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Response to Graft Versus Host Disease (GVHD) Treatment
Partial Response (PR)
|
1 participants
|
0 participants
|
0 participants
|
—
|
|
Response to Graft Versus Host Disease (GVHD) Treatment
Non-responder (NR)
|
6 participants
|
1 participants
|
3 participants
|
—
|
|
Response to Graft Versus Host Disease (GVHD) Treatment
Progressive Disease (PD)
|
2 participants
|
0 participants
|
1 participants
|
—
|
SECONDARY outcome
Timeframe: Date treatment consent signed to date off study, approximately 36 months.Here is the number of participants with adverse events. For the detailed list of adverse events, see the adverse event module.
Outcome measures
| Measure |
Donor Lymphocyte Infusion/Radiation
n=9 Participants
Subjects will receive a unmanipulated donor lymphocyte infusion (DLI) on Day 1 after radiation (single, 8-Gy fraction to the maximum number of lesions).
|
Radiation/No Donor Lymphocyte Infusion
n=1 Participants
Subjects will receive radiation (single, 8-Gy fraction to the maximum number of lesions).
|
Donor Lymphocyte Infusion-Control
n=4 Participants
Subjects will receive a unmanipulated donor lymphocyte infusion (DLI) on Day 0.
|
Donor Lymphocyte Infusion - Donor
n=4 Participants
Healthy subjects who donated lymphocytes for infusion on a treatment Arm.
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events
|
9 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
Adverse Events
Donor Lymphocyte Infusion/Radiation
Serious events: 4 serious events
Other events: 9 other events
Deaths: 0 deaths
Radiation/No Donor Lymphocyte Infusion
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Donor Lymphocyte Infusion - Control
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Donor Lymphocyte Infusion - Donor
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Donor Lymphocyte Infusion/Radiation
n=9 participants at risk
Subjects will receive a unmanipulated donor lymphocyte infusion (DLI) on Day 1 after radiation (single, 8-Gy fraction to the maximum number of lesions).
|
Radiation/No Donor Lymphocyte Infusion
n=1 participants at risk
Subjects will receive radiation (single, 8-Gy fraction to the maximum number of lesions).
|
Donor Lymphocyte Infusion - Control
n=4 participants at risk
Subjects will receive a unmanipulated donor lymphocyte infusion (DLI) on Day 0.
|
Donor Lymphocyte Infusion - Donor
n=4 participants at risk
Healthy subjects who donated lymphocytes for infusion on a treatment Arm.
|
|---|---|---|---|---|
|
Metabolism and nutrition disorders
Acidosis
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
Renal and urinary disorders
Acute kidney injury
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
Blood and lymphatic system disorders
Anemia
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
Gastrointestinal disorders
Ascites
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
11.1%
1/9 • Number of events 2 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
Psychiatric disorders
Confusion
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
Psychiatric disorders
Delirium
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
Nervous system disorders
Dizziness
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
General disorders
General disorders and administration site conditions - Other, specify (coma)
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
33.3%
3/9 • Number of events 5 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
Infections and infestations
Infections and infestations - Other, specify (aspergillis (+) in sputum)
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
Infections and infestations
Infections and infestations - Other, specify (sputum, pseudomonas (+))
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal edema
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
Nervous system disorders
Lethargy
|
11.1%
1/9 • Number of events 2 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
Infections and infestations
Lung infection
|
22.2%
2/9 • Number of events 2 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
General disorders
Multi-organ failure
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
Investigations
Neutrophil count decreased
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
Infections and infestations
Pleural infection
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
Cardiac disorders
Sinus tachycardia
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
Other adverse events
| Measure |
Donor Lymphocyte Infusion/Radiation
n=9 participants at risk
Subjects will receive a unmanipulated donor lymphocyte infusion (DLI) on Day 1 after radiation (single, 8-Gy fraction to the maximum number of lesions).
|
Radiation/No Donor Lymphocyte Infusion
n=1 participants at risk
Subjects will receive radiation (single, 8-Gy fraction to the maximum number of lesions).
|
Donor Lymphocyte Infusion - Control
n=4 participants at risk
Subjects will receive a unmanipulated donor lymphocyte infusion (DLI) on Day 0.
|
Donor Lymphocyte Infusion - Donor
n=4 participants at risk
Healthy subjects who donated lymphocytes for infusion on a treatment Arm.
|
|---|---|---|---|---|
|
Investigations
Activated partial thromboplastin time prolonged
|
55.6%
5/9 • Number of events 6 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
3/9 • Number of events 4 • Date treatment consent signed to date off study, approximately 36 months.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
|
25.0%
1/4 • Number of events 2 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
Investigations
Alkaline phosphatase increased
|
44.4%
4/9 • Number of events 4 • Date treatment consent signed to date off study, approximately 36 months.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
Metabolism and nutrition disorders
Alkalosis
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
Blood and lymphatic system disorders
Anemia
|
66.7%
6/9 • Number of events 10 • Date treatment consent signed to date off study, approximately 36 months.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
Metabolism and nutrition disorders
Anorexia
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
Investigations
Aspartate aminotransferase increased
|
44.4%
4/9 • Number of events 4 • Date treatment consent signed to date off study, approximately 36 months.
|
100.0%
1/1 • Number of events 2 • Date treatment consent signed to date off study, approximately 36 months.
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.1%
1/9 • Number of events 2 • Date treatment consent signed to date off study, approximately 36 months.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
Investigations
Blood bilirubin increased
|
22.2%
2/9 • Number of events 6 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
Investigations
CPK increased
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
General disorders
Chills
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
Psychiatric disorders
Confusion
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
Investigations
Creatinine increased
|
22.2%
2/9 • Number of events 3 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
Eye disorders
Dry eye
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
Gastrointestinal disorders
Dysphagia
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify (b/l ear fullness)
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
General disorders
Fatigue
|
33.3%
3/9 • Number of events 3 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 36 months.
|
50.0%
2/4 • Number of events 2 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
General disorders
Fever
|
22.2%
2/9 • Number of events 4 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
General disorders
Flu like symptoms
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
Investigations
Haptoglobin decreased
|
11.1%
1/9 • Number of events 2 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
Ear and labyrinth disorders
Hearing impaired
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
11.1%
1/9 • Number of events 2 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
22.2%
2/9 • Number of events 2 • Date treatment consent signed to date off study, approximately 36 months.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
22.2%
2/9 • Number of events 2 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
22.2%
2/9 • Number of events 4 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 36 months.
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
22.2%
2/9 • Number of events 3 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
66.7%
6/9 • Number of events 6 • Date treatment consent signed to date off study, approximately 36 months.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
|
50.0%
2/4 • Number of events 2 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
33.3%
3/9 • Number of events 3 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
22.2%
2/9 • Number of events 2 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
44.4%
4/9 • Number of events 8 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 36 months.
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
22.2%
2/9 • Number of events 3 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
33.3%
3/9 • Number of events 9 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal edema
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
Investigations
Lymphocyte count decreased
|
44.4%
4/9 • Number of events 7 • Date treatment consent signed to date off study, approximately 36 months.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
|
25.0%
1/4 • Number of events 2 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
Ear and labyrinth disorders
Middle ear inflammation
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
Gastrointestinal disorders
Mucositis oral
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
General disorders
Neck edema
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
Investigations
Neutrophil count decreased
|
66.7%
6/9 • Number of events 17 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
General disorders
Pain
|
33.3%
3/9 • Number of events 3 • Date treatment consent signed to date off study, approximately 36 months.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
Investigations
Platelet count decreased
|
44.4%
4/9 • Number of events 9 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
Nervous system disorders
Radiculitis
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
22.2%
2/9 • Number of events 2 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 36 months.
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
Cardiac disorders
Supraventricular tachycardia
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
Infections and infestations
Upper respiratory infection
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
Investigations
White blood cell decreased
|
66.7%
6/9 • Number of events 14 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 36 months.
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
Infections and infestations
Infections and infestations - Other, specify (angular cheilitis)
|
0.00%
0/9 • Date treatment consent signed to date off study, approximately 36 months.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/9 • Date treatment consent signed to date off study, approximately 36 months.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
Infections and infestations
Lung infection
|
0.00%
0/9 • Date treatment consent signed to date off study, approximately 36 months.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/9 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 36 months.
|
50.0%
2/4 • Number of events 2 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/9 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 36 months.
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/9 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 36 months.
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 36 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place