Trial Outcomes & Findings for Three Immunosuppressive Treatment Regimens for Severe Aplastic Anemia (NCT NCT00260689)
NCT ID: NCT00260689
Last Updated: 2017-06-08
Results Overview
Hematologic response is defined as subjects having blood counts no longer meeting the standard ("Camitta") criteria for severe pancytopenia in Severe Aplastic Anemia, equivalent to 2 of the following values obtained on 2 serial blood count measurements at least one week apart at landmark time points (3, 6 and 12 months) * Absolute neutrophil count \> 500/ μL * Platelet count \> 20,000/ μL * Reticulocyte count \> 60,000/ μL Improvement in counts that are dependent upon exogenously administered growth factors or transfusion will not be considered as fulfilling response criteria.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
136 participants
Primary outcome timeframe
3 months
Results posted on
2017-06-08
Participant Flow
Participant milestones
| Measure |
Horse ATG/CsA Taper
Horse Anti-thymocyte Globulin (h-ATG) + 6 months Cyclosporine (CsA) followed by an 18 month CsA taper
|
Rabbit ATG/CsA
Rabbit Anti-thymocyte Globulin (r-ATG) + 6 months Cyclosporine (CsA)
|
Alemtuzumab
Alemtuzumab (Campath) administered for 10 days
|
|---|---|---|---|
|
Overall Study
STARTED
|
60
|
60
|
16
|
|
Overall Study
COMPLETED
|
19
|
11
|
1
|
|
Overall Study
NOT COMPLETED
|
41
|
49
|
15
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Three Immunosuppressive Treatment Regimens for Severe Aplastic Anemia
Baseline characteristics by cohort
| Measure |
Horse ATG/CsA Taper
n=60 Participants
Horse Anti-thymocyte Globulin (h-ATG) + 6 months Cyclosporine (CsA) followed by an 18 month CsA taper
|
Rabbit ATG/CsA
n=60 Participants
Rabbit Anti-thymocyte Globulin (r-ATG) + 6 months Cyclosporine (CsA)
|
Alemtuzumab
n=16 Participants
Alemtuzumab (Campath) administered for 10 days
|
Total
n=136 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
14 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
38 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
81 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
82 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
50 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
103 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
8 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 3 monthsHematologic response is defined as subjects having blood counts no longer meeting the standard ("Camitta") criteria for severe pancytopenia in Severe Aplastic Anemia, equivalent to 2 of the following values obtained on 2 serial blood count measurements at least one week apart at landmark time points (3, 6 and 12 months) * Absolute neutrophil count \> 500/ μL * Platelet count \> 20,000/ μL * Reticulocyte count \> 60,000/ μL Improvement in counts that are dependent upon exogenously administered growth factors or transfusion will not be considered as fulfilling response criteria.
Outcome measures
| Measure |
Horse ATG/CsA Taper
n=60 Participants
Horse Anti-thymocyte Globulin (h-ATG) + 6 months Cyclosporine (CsA) followed by an 18 month CsA taper
|
Rabbit ATG/CsA
n=60 Participants
Rabbit Anti-thymocyte Globulin (r-ATG) + 6 months Cyclosporine (CsA)
|
Alemtuzumab
n=16 Participants
Alemtuzumab (Campath) administered for 10 days
|
|---|---|---|---|
|
Hematologic Response
|
38 Participants
|
20 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: 6 monthsHematologic response is defined as subjects having blood counts no longer meeting the standard ("Camitta") criteria for severe pancytopenia in Severe Aplastic Anemia, equivalent to 2 of the following values obtained on 2 serial blood count measurements at least one week apart at landmark time points (3, 6 and 12 months) * Absolute neutrophil count \> 500/ μL * Platelet count \> 20,000/ μL * Reticulocyte count \> 60,000/ μL Improvement in counts that are dependent upon exogenously administered growth factors or transfusion will not be considered as fulfilling response criteria.
Outcome measures
| Measure |
Horse ATG/CsA Taper
n=60 Participants
Horse Anti-thymocyte Globulin (h-ATG) + 6 months Cyclosporine (CsA) followed by an 18 month CsA taper
|
Rabbit ATG/CsA
n=60 Participants
Rabbit Anti-thymocyte Globulin (r-ATG) + 6 months Cyclosporine (CsA)
|
Alemtuzumab
n=16 Participants
Alemtuzumab (Campath) administered for 10 days
|
|---|---|---|---|
|
Hematologic Response
|
41 Participants
|
22 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: 12 monthsHematologic response is defined as subjects having blood counts no longer meeting the standard ("Camitta") criteria for severe pancytopenia in Severe Aplastic Anemia, equivalent to 2 of the following values obtained on 2 serial blood count measurements at least one week apart at landmark time points (3, 6 and 12 months) * Absolute neutrophil count \> 500/ μL * Platelet count \> 20,000/ μL * Reticulocyte count \> 60,000/ μL Improvement in counts that are dependent upon exogenously administered growth factors or transfusion will not be considered as fulfilling response criteria.
Outcome measures
| Measure |
Horse ATG/CsA Taper
n=60 Participants
Horse Anti-thymocyte Globulin (h-ATG) + 6 months Cyclosporine (CsA) followed by an 18 month CsA taper
|
Rabbit ATG/CsA
n=60 Participants
Rabbit Anti-thymocyte Globulin (r-ATG) + 6 months Cyclosporine (CsA)
|
Alemtuzumab
n=16 Participants
Alemtuzumab (Campath) administered for 10 days
|
|---|---|---|---|
|
Hematologic Response
|
40 Participants
|
18 Participants
|
2 Participants
|
Adverse Events
Horse ATG/CsA Taper
Serious events: 7 serious events
Other events: 36 other events
Deaths: 11 deaths
Rabbit ATG/CsA
Serious events: 11 serious events
Other events: 39 other events
Deaths: 18 deaths
Alemtuzumab
Serious events: 6 serious events
Other events: 15 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Horse ATG/CsA Taper
n=60 participants at risk
Horse Anti-thymocyte Globulin (h-ATG) + 6 months Cyclosporine (CsA) followed by an 18 month CsA taper
|
Rabbit ATG/CsA
n=60 participants at risk
Rabbit Anti-thymocyte Globulin (r-ATG) + 6 months Cyclosporine (CsA)
|
Alemtuzumab
n=16 participants at risk
Alemtuzumab (Campath) administered for 10 days
|
|---|---|---|---|
|
Blood and lymphatic system disorders
CNS hemorrhage/bleeding
|
0.00%
0/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Blood and lymphatic system disorders
Edema: limb
|
0.00%
0/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Cardiac disorders
Cardiac troponin I
|
1.7%
1/60 • 5 years
|
0.00%
0/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Cardiac disorders
Hypertension
|
0.00%
0/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Cardiac disorders
Supraventricular arrhythmia
|
0.00%
0/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Immune system disorders
Serum sickness
|
3.3%
2/60 • 5 years
|
6.7%
4/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Immune system disorders
Serum sickness/Infection
|
0.00%
0/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Infections and infestations
Infection (documented clinically or microbiologically with grade 3 or 4 neutropenia)
|
5.0%
3/60 • 5 years
|
1.7%
1/60 • 5 years
|
31.2%
5/16 • 5 years
|
|
Infections and infestations
Infection without neutropenia
|
0.00%
0/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Metabolism and nutrition disorders
Creatinine (grade 2)
|
1.7%
1/60 • 5 years
|
0.00%
0/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/60 • 5 years
|
0.00%
0/60 • 5 years
|
6.2%
1/16 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia (joint pain)
|
1.7%
1/60 • 5 years
|
0.00%
0/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Nervous system disorders
Seizures
|
0.00%
0/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
Other adverse events
| Measure |
Horse ATG/CsA Taper
n=60 participants at risk
Horse Anti-thymocyte Globulin (h-ATG) + 6 months Cyclosporine (CsA) followed by an 18 month CsA taper
|
Rabbit ATG/CsA
n=60 participants at risk
Rabbit Anti-thymocyte Globulin (r-ATG) + 6 months Cyclosporine (CsA)
|
Alemtuzumab
n=16 participants at risk
Alemtuzumab (Campath) administered for 10 days
|
|---|---|---|---|
|
Blood and lymphatic system disorders
edema
|
0.00%
0/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Blood and lymphatic system disorders
edema - mild lower extremity
|
1.7%
1/60 • 5 years
|
0.00%
0/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Blood and lymphatic system disorders
gingival hypertrophy
|
0.00%
0/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Blood and lymphatic system disorders
Hemolysis
|
1.7%
1/60 • 5 years
|
0.00%
0/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Blood and lymphatic system disorders
lower extremity edema
|
0.00%
0/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Blood and lymphatic system disorders
lower extremity swelling
|
0.00%
0/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Blood and lymphatic system disorders
slight edema pitting
|
1.7%
1/60 • 5 years
|
0.00%
0/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Blood and lymphatic system disorders
slight pitting edema
|
0.00%
0/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Blood and lymphatic system disorders
swelling (lower extremity)
|
1.7%
1/60 • 5 years
|
0.00%
0/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Blood and lymphatic system disorders
swelling ankles
|
1.7%
1/60 • 5 years
|
0.00%
0/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Blood and lymphatic system disorders
swelling feet and hands
|
0.00%
0/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Cardiac disorders
bradycardia
|
0.00%
0/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Cardiac disorders
Edema, ankles
|
3.3%
2/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Cardiac disorders
Edema, lower legs
|
5.0%
3/60 • 5 years
|
1.7%
1/60 • 5 years
|
6.2%
1/16 • 5 years
|
|
Cardiac disorders
fluid overload
|
3.3%
2/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Cardiac disorders
h Blood pressure
|
1.7%
1/60 • 5 years
|
0.00%
0/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Cardiac disorders
h BP
|
5.0%
3/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Cardiac disorders
high blood pressure
|
1.7%
1/60 • 5 years
|
0.00%
0/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Cardiac disorders
Hypertension
|
13.3%
8/60 • 5 years
|
15.0%
9/60 • 5 years
|
18.8%
3/16 • 5 years
|
|
Cardiac disorders
hypotension
|
3.3%
2/60 • 5 years
|
5.0%
3/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Cardiac disorders
i SBP
|
1.7%
1/60 • 5 years
|
0.00%
0/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Cardiac disorders
irregular pulse
|
0.00%
0/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Cardiac disorders
S tachycardia
|
0.00%
0/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Cardiac disorders
substernal pressure
|
0.00%
0/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/60 • 5 years
|
0.00%
0/60 • 5 years
|
6.2%
1/16 • 5 years
|
|
Cardiac disorders
Tachycardia
|
3.3%
2/60 • 5 years
|
1.7%
1/60 • 5 years
|
6.2%
1/16 • 5 years
|
|
Endocrine disorders
Hot flashes
|
0.00%
0/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Endocrine disorders
Hypothyroidism, subclinical
|
0.00%
0/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Eye disorders
Photophobia
|
0.00%
0/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Gastrointestinal disorders
abdominal distension
|
0.00%
0/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Gastrointestinal disorders
abdominal gas
|
0.00%
0/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Gastrointestinal disorders
abdominal pain
|
3.3%
2/60 • 5 years
|
0.00%
0/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Gastrointestinal disorders
abdominal pain with loose stools
|
1.7%
1/60 • 5 years
|
0.00%
0/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Gastrointestinal disorders
bleeding, swollen gums
|
0.00%
0/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Gastrointestinal disorders
bloated
|
1.7%
1/60 • 5 years
|
0.00%
0/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Gastrointestinal disorders
decreased
|
0.00%
0/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Gastrointestinal disorders
dehydration
|
1.7%
1/60 • 5 years
|
0.00%
0/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Gastrointestinal disorders
diarrhea
|
8.3%
5/60 • 5 years
|
13.3%
8/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Gastrointestinal disorders
Gingival hyperplasia
|
3.3%
2/60 • 5 years
|
6.7%
4/60 • 5 years
|
12.5%
2/16 • 5 years
|
|
Gastrointestinal disorders
gingivial hyperplasia
|
0.00%
0/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Gastrointestinal disorders
gingivial hyperplasia - mild
|
1.7%
1/60 • 5 years
|
0.00%
0/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Gastrointestinal disorders
gingivitis
|
0.00%
0/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Gastrointestinal disorders
gum hyperplasia
|
0.00%
0/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Gastrointestinal disorders
gum hypertrophy
|
0.00%
0/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Gastrointestinal disorders
Heartburn
|
5.0%
3/60 • 5 years
|
1.7%
1/60 • 5 years
|
6.2%
1/16 • 5 years
|
|
Gastrointestinal disorders
i K+
|
0.00%
0/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Gastrointestinal disorders
Indigestion
|
1.7%
1/60 • 5 years
|
0.00%
0/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Gastrointestinal disorders
loose stool
|
1.7%
1/60 • 5 years
|
0.00%
0/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Gastrointestinal disorders
Nausea
|
5.0%
3/60 • 5 years
|
6.7%
4/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Gastrointestinal disorders
nausea + vomiting
|
3.3%
2/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Gastrointestinal disorders
poor appetite
|
1.7%
1/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Gastrointestinal disorders
vomiting
|
3.3%
2/60 • 5 years
|
5.0%
3/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
General disorders
Abdominal
|
1.7%
1/60 • 5 years
|
0.00%
0/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
General disorders
abdominal pain
|
1.7%
1/60 • 5 years
|
3.3%
2/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
General disorders
Abdominal, cramps
|
0.00%
0/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
General disorders
body aches
|
1.7%
1/60 • 5 years
|
0.00%
0/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
General disorders
chest discomfort
|
1.7%
1/60 • 5 years
|
0.00%
0/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
General disorders
chest pain
|
0.00%
0/60 • 5 years
|
3.3%
2/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
General disorders
Chest pressure
|
0.00%
0/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
General disorders
chest tightness
|
1.7%
1/60 • 5 years
|
0.00%
0/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
General disorders
chills
|
0.00%
0/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
General disorders
chills/rigors
|
0.00%
0/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
General disorders
epigastric pain
|
0.00%
0/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
General disorders
fever
|
10.0%
6/60 • 5 years
|
8.3%
5/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
General disorders
Headache
|
16.7%
10/60 • 5 years
|
10.0%
6/60 • 5 years
|
6.2%
1/16 • 5 years
|
|
General disorders
leg pain
|
0.00%
0/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
General disorders
Localized, back
|
0.00%
0/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
General disorders
Localized, feet (burning), knee
|
0.00%
0/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
General disorders
Localized, low back
|
1.7%
1/60 • 5 years
|
0.00%
0/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
General disorders
Localized, soles of feet, legs
|
1.7%
1/60 • 5 years
|
0.00%
0/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
General disorders
Localized, Throat
|
0.00%
0/60 • 5 years
|
0.00%
0/60 • 5 years
|
6.2%
1/16 • 5 years
|
|
General disorders
Localized, throat, abdomen
|
0.00%
0/60 • 5 years
|
0.00%
0/60 • 5 years
|
6.2%
1/16 • 5 years
|
|
General disorders
Localized, Wrist, bilateral
|
0.00%
0/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
General disorders
low back pain
|
1.7%
1/60 • 5 years
|
0.00%
0/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
General disorders
Myalgia (general)
|
0.00%
0/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
General disorders
Myalgia, arthralgia
|
0.00%
0/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
General disorders
Myalgia, back
|
0.00%
0/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
General disorders
Myalgia, calves
|
1.7%
1/60 • 5 years
|
0.00%
0/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
General disorders
neutropenic fever
|
3.3%
2/60 • 5 years
|
5.0%
3/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
General disorders
retrosternal chest pain
|
0.00%
0/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
General disorders
rigor
|
1.7%
1/60 • 5 years
|
0.00%
0/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
General disorders
rigors
|
8.3%
5/60 • 5 years
|
3.3%
2/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
General disorders
stomach discomfort
|
0.00%
0/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
General disorders
tired
|
0.00%
0/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
General disorders
weight gain
|
3.3%
2/60 • 5 years
|
3.3%
2/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
General disorders
weight increase
|
1.7%
1/60 • 5 years
|
0.00%
0/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
General disorders
weight loss
|
0.00%
0/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Hepatobiliary disorders
Elevated LFT's
|
15.0%
9/60 • 5 years
|
15.0%
9/60 • 5 years
|
31.2%
5/16 • 5 years
|
|
Hepatobiliary disorders
Elevated t. bili
|
8.3%
5/60 • 5 years
|
10.0%
6/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Immune system disorders
flu-like symptoms
|
1.7%
1/60 • 5 years
|
0.00%
0/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Immune system disorders
joint Pain
|
0.00%
0/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Immune system disorders
Labeled infusion related
|
46.7%
28/60 • 5 years
|
51.7%
31/60 • 5 years
|
93.8%
15/16 • 5 years
|
|
Immune system disorders
Serum sickness
|
3.3%
2/60 • 5 years
|
8.3%
5/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Immune system disorders
swelling
|
1.7%
1/60 • 5 years
|
0.00%
0/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Immune system disorders
throat swelling
|
0.00%
0/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Infections and infestations
C. diff colitis
|
0.00%
0/60 • 5 years
|
5.0%
3/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Infections and infestations
C. diff colitis and Blastocystis hominis
|
0.00%
0/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Infections and infestations
Gingivitis
|
5.0%
3/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Infections and infestations
Mouth sores
|
5.0%
3/60 • 5 years
|
5.0%
3/60 • 5 years
|
6.2%
1/16 • 5 years
|
|
Infections and infestations
Mouth sores (neg. Cxs)
|
0.00%
0/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Infections and infestations
Shingles
|
1.7%
1/60 • 5 years
|
0.00%
0/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Infections and infestations
Trush
|
1.7%
1/60 • 5 years
|
1.7%
1/60 • 5 years
|
6.2%
1/16 • 5 years
|
|
Infections and infestations
Upper Respiratory Tract
|
0.00%
0/60 • 5 years
|
1.7%
1/60 • 5 years
|
6.2%
1/16 • 5 years
|
|
Metabolism and nutrition disorders
h ALT
|
1.7%
1/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Metabolism and nutrition disorders
h ALT/di bili
|
0.00%
0/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Metabolism and nutrition disorders
h AST
|
0.00%
0/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Metabolism and nutrition disorders
h creatinine
|
5.0%
3/60 • 5 years
|
6.7%
4/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Metabolism and nutrition disorders
h creatinine -mild
|
1.7%
1/60 • 5 years
|
0.00%
0/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Metabolism and nutrition disorders
h K
|
0.00%
0/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Metabolism and nutrition disorders
h LDH
|
0.00%
0/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Metabolism and nutrition disorders
h LFT
|
3.3%
2/60 • 5 years
|
0.00%
0/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Metabolism and nutrition disorders
h LFT, creatinine
|
0.00%
0/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Metabolism and nutrition disorders
h LFTs
|
1.7%
1/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Metabolism and nutrition disorders
h PT, PTT
|
0.00%
0/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Metabolism and nutrition disorders
Hyperglicemia
|
3.3%
2/60 • 5 years
|
3.3%
2/60 • 5 years
|
6.2%
1/16 • 5 years
|
|
Metabolism and nutrition disorders
hyperglycemia
|
1.7%
1/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Metabolism and nutrition disorders
hyperkalemia
|
3.3%
2/60 • 5 years
|
0.00%
0/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Metabolism and nutrition disorders
hypernatremia
|
0.00%
0/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Metabolism and nutrition disorders
hypertension
|
0.00%
0/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Metabolism and nutrition disorders
hypoglycemia
|
1.7%
1/60 • 5 years
|
0.00%
0/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Metabolism and nutrition disorders
hypokalemia
|
0.00%
0/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Metabolism and nutrition disorders
hypomagnesia
|
1.7%
1/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Metabolism and nutrition disorders
i magnesium
|
3.3%
2/60 • 5 years
|
3.3%
2/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Metabolism and nutrition disorders
LFT abnormal
|
1.7%
1/60 • 5 years
|
0.00%
0/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Metabolism and nutrition disorders
low albumin
|
0.00%
0/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Metabolism and nutrition disorders
renal failure
|
1.7%
1/60 • 5 years
|
0.00%
0/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Cramps
|
1.7%
1/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Nervous system disorders
anxiety
|
1.7%
1/60 • 5 years
|
0.00%
0/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Nervous system disorders
Anxiety, irritability
|
0.00%
0/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Nervous system disorders
dizziness
|
0.00%
0/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Nervous system disorders
Insomnia
|
0.00%
0/60 • 5 years
|
3.3%
2/60 • 5 years
|
6.2%
1/16 • 5 years
|
|
Nervous system disorders
numbness
|
1.7%
1/60 • 5 years
|
0.00%
0/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Nervous system disorders
Numbness fingers, wrists
|
1.7%
1/60 • 5 years
|
0.00%
0/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Nervous system disorders
numbness/tingling (bilateral lower extremities)
|
1.7%
1/60 • 5 years
|
0.00%
0/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Nervous system disorders
parastesias
|
0.00%
0/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Nervous system disorders
Perioral tingling
|
1.7%
1/60 • 5 years
|
0.00%
0/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Nervous system disorders
Peripheral neuropathy, CsA induced
|
0.00%
0/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Nervous system disorders
tingling
|
0.00%
0/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Nervous system disorders
Tremor, hands
|
0.00%
0/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Nervous system disorders
tremors
|
0.00%
0/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Renal and urinary disorders
acute kidney injury
|
1.7%
1/60 • 5 years
|
0.00%
0/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/60 • 5 years
|
1.7%
1/60 • 5 years
|
6.2%
1/16 • 5 years
|
|
Renal and urinary disorders
mild renal insufficiency
|
1.7%
1/60 • 5 years
|
0.00%
0/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
1.7%
1/60 • 5 years
|
0.00%
0/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
crackles
|
1.7%
1/60 • 5 years
|
0.00%
0/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
crackles in lungs
|
0.00%
0/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
crackles lungs
|
1.7%
1/60 • 5 years
|
0.00%
0/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
dry cough
|
1.7%
1/60 • 5 years
|
0.00%
0/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
short of breath
|
1.7%
1/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
sob
|
3.3%
2/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Skin and subcutaneous tissue disorders
Acne
|
1.7%
1/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Skin and subcutaneous tissue disorders
Body hair growth
|
1.7%
1/60 • 5 years
|
0.00%
0/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Skin and subcutaneous tissue disorders
Dandruff
|
1.7%
1/60 • 5 years
|
0.00%
0/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Skin and subcutaneous tissue disorders
Erythema, LE
|
1.7%
1/60 • 5 years
|
0.00%
0/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Skin and subcutaneous tissue disorders
erythematous rash
|
0.00%
0/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Skin and subcutaneous tissue disorders
hair growth
|
0.00%
0/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Skin and subcutaneous tissue disorders
increased hair growth
|
0.00%
0/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Skin and subcutaneous tissue disorders
itchy palms
|
1.7%
1/60 • 5 years
|
0.00%
0/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Skin and subcutaneous tissue disorders
palm itching
|
1.7%
1/60 • 5 years
|
0.00%
0/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Skin and subcutaneous tissue disorders
palms slightly red
|
0.00%
0/60 • 5 years
|
1.7%
1/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.3%
2/60 • 5 years
|
3.3%
2/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Skin and subcutaneous tissue disorders
rash (arms)
|
1.7%
1/60 • 5 years
|
0.00%
0/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Skin and subcutaneous tissue disorders
rash - mild
|
1.7%
1/60 • 5 years
|
0.00%
0/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Skin and subcutaneous tissue disorders
rash face
|
1.7%
1/60 • 5 years
|
0.00%
0/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Skin and subcutaneous tissue disorders
Rash, face
|
0.00%
0/60 • 5 years
|
0.00%
0/60 • 5 years
|
6.2%
1/16 • 5 years
|
|
Skin and subcutaneous tissue disorders
rash, hives, itching
|
1.7%
1/60 • 5 years
|
0.00%
0/60 • 5 years
|
0.00%
0/16 • 5 years
|
|
Skin and subcutaneous tissue disorders
urticarial rash -mild
|
1.7%
1/60 • 5 years
|
0.00%
0/60 • 5 years
|
0.00%
0/16 • 5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place