Trial Outcomes & Findings for Atorvastatin as GVHD Prophylaxis for Allogeneic Hematopoietic Cell Transplantation (NCT NCT01665677)
NCT ID: NCT01665677
Last Updated: 2023-05-15
Results Overview
The number of subjects in the matched sibling cohort who develop grades II-IV acute GVHD will be assessed by consensus criteria and graded on Bone Marrow Transplant Clinical Trials Network Manual of Procedures suggested grading sheets. Grade I is mild GVHD involving up to 25% of the subject's skin; Grade II is moderate GVHD. involving 25 to 50% of the subject's skin and can include mild changes in liver and/or mild diarrhea; Grade III is severe GVHD involving over 50% of the subject's skin. Liver involvement is likely as are stomach cramps and diarrhea; and Grade 4 is very severe GvHD. Skin may be blistered and may have broken down in places. Skin may be yellow due to liver injury. Severe diarrhea is common. Subjects in the matched unrelated donors are not included in this analysis.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
69 participants
Primary outcome timeframe
Day 100
Results posted on
2023-05-15
Participant Flow
75 subjects signed consent. Six did not meet eligibility criteria and were not treated.
Participant milestones
| Measure |
Matched Related Donor
Atorvastatin will be administered at a dose of 40 mg orally daily starting on day -14, to permit an approximately 1-week observation period to rule out any acute atorvastatin-induced side effects before the initiation of transplant conditioning.
Patients will receive atorvastatin until +180 days or until the patient develops grade II-IV acute GVHD, extensive chronic GVHD, or any grade 3-4 toxicity related to atorvastatin.
Atorvastatin calcium: 40 mg PO daily
|
Matched Unrelated Donor
Atorvastatin will be administered at a dose of 40 mg orally daily starting on day -14, to permit an approximately 1-week observation period to rule out any acute atorvastatin-induced side effects before the initiation of transplant conditioning.
Patients will receive atorvastatin until +180 days or until the patient develops grade II-IV acute GVHD, extensive chronic GVHD, or any grade 3-4 toxicity related to atorvastatin.
Atorvastatin calcium: 40 mg PO daily
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
39
|
|
Overall Study
COMPLETED
|
30
|
39
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Atorvastatin as GVHD Prophylaxis for Allogeneic Hematopoietic Cell Transplantation
Baseline characteristics by cohort
| Measure |
Atorvastatin Calcium (Lipitor)
n=30 Participants
Atorvastatin will be administered at a dose of 40 mg orally daily starting on day -14, to permit an approximately 1-week observation period to rule out any acute atorvastatin-induced side effects before the initiation of transplant conditioning.
Patients will receive atorvastatin until +180 days or until the patient develops grade II-IV acute GVHD, extensive chronic GVHD, or any grade 3-4 toxicity related to atorvastatin.
Atorvastatin calcium: 40 mg PO daily
|
Unrelated Donor
n=39 Participants
Atorvastatin will be administered at a dose of 40 mg orally daily starting on day -14, to permit an approximately 1-week observation period to rule out any acute atorvastatin-induced side effects before the initiation of transplant conditioning.
Patients will receive atorvastatin until +180 days or until the patient develops grade II-IV acute GVHD, extensive chronic GVHD, or any grade 3-4 toxicity related to atorvastatin.
Atorvastatin calcium: 40 mg PO daily
|
Total
n=69 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
|
21 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 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
|
28 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
39 participants
n=7 Participants
|
69 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 100The number of subjects in the matched sibling cohort who develop grades II-IV acute GVHD will be assessed by consensus criteria and graded on Bone Marrow Transplant Clinical Trials Network Manual of Procedures suggested grading sheets. Grade I is mild GVHD involving up to 25% of the subject's skin; Grade II is moderate GVHD. involving 25 to 50% of the subject's skin and can include mild changes in liver and/or mild diarrhea; Grade III is severe GVHD involving over 50% of the subject's skin. Liver involvement is likely as are stomach cramps and diarrhea; and Grade 4 is very severe GvHD. Skin may be blistered and may have broken down in places. Skin may be yellow due to liver injury. Severe diarrhea is common. Subjects in the matched unrelated donors are not included in this analysis.
Outcome measures
| Measure |
Matched Related Donor
n=30 Participants
Atorvastatin will be administered at a dose of 40 mg orally daily starting on day -14, to permit an approximately 1-week observation period to rule out any acute atorvastatin-induced side effects before the initiation of transplant conditioning.
Patients will receive atorvastatin until +180 days or until the patient develops grade II-IV acute GVHD, extensive chronic GVHD, or any grade 3-4 toxicity related to atorvastatin.
Atorvastatin calcium: 40 mg PO daily
|
|---|---|
|
Matched Related Transplants Who Develop Grade II-IV Acute Graft Versus Host Disease (GVHD).
|
3 Participants
|
PRIMARY outcome
Timeframe: Day 100The number of subjects in the matched unrelated donor cohort who develop grade II-IV acute GVHD. Acute GVHD will be assessed by consensus criteria and graded on Bone Marrow Transplant Clinical Trials Network Manual of Procedures suggested grading sheets. Grade I is mild GVHD involving up to 25% of the subject's skin; Grade II is moderate GVHD. involving 25 to 50% of the subject's skin and can include mild changes in liver and/or mild diarrhea; Grade III is severe GVHD involving over 50% of the subject's skin. Liver involvement is likely as are stomach cramps and diarrhea; and Grade 4 is very severe GvHD. Skin may be blistered and may have broken down in places. Skin may be yellow due to liver injury. Severe diarrhea is common. Subjects in the matched related donors are not included in this analysis.
Outcome measures
| Measure |
Matched Related Donor
n=39 Participants
Atorvastatin will be administered at a dose of 40 mg orally daily starting on day -14, to permit an approximately 1-week observation period to rule out any acute atorvastatin-induced side effects before the initiation of transplant conditioning.
Patients will receive atorvastatin until +180 days or until the patient develops grade II-IV acute GVHD, extensive chronic GVHD, or any grade 3-4 toxicity related to atorvastatin.
Atorvastatin calcium: 40 mg PO daily
|
|---|---|
|
Matched Unrelated Donors Transplants Who Develop Grade II-IV Acute GVHD.
|
12 Participants
|
SECONDARY outcome
Timeframe: 1 yearThe number of subjects who develop grade II-IV chronic GVHD. Chronic GVHD diagnosis and grading I to IV will be according to National Institutes of Health (NIH) Criteria rating progressively intense symptoms involving: skin (asymptomatic to deep sclerosis, impaired mobility, ulceration, or pruritus), oral cavity (asymptomatic to symptoms limiting oral intake), eyes (asymptomatic to severe dry eye, inability to work, or loss of vision due to keratoconjunctivitis), gastrointestinal tract (asymptomatic to significant weight loss \[\>15%\] or esophageal dilation), liver (normal function to bilirubin or enzymes \>5 times ULN), lungs (asymptomatic to severe shortness of breath requiring supplemental oxygen), joints and fascia (asymptomatic to contractures with reduced range of motion and limited ability to perform daily care), and genital tract (asymptomatic to strictures and severe pain). Subjects in the matched unrelated donors are not included in this analysis.
Outcome measures
| Measure |
Matched Related Donor
n=30 Participants
Atorvastatin will be administered at a dose of 40 mg orally daily starting on day -14, to permit an approximately 1-week observation period to rule out any acute atorvastatin-induced side effects before the initiation of transplant conditioning.
Patients will receive atorvastatin until +180 days or until the patient develops grade II-IV acute GVHD, extensive chronic GVHD, or any grade 3-4 toxicity related to atorvastatin.
Atorvastatin calcium: 40 mg PO daily
|
|---|---|
|
Matched Related Transplants Who Develop Grade II-IV Chronic GVHD.
|
9 Participants
|
SECONDARY outcome
Timeframe: 1 yearThe number of subjects who develop grade II-IV chronic GVHD. Chronic GVHD diagnosis and grading I to IV will be according to National Institutes of Health (NIH) Criteria rating progressively intense symptoms involving: skin (asymptomatic to deep sclerosis, impaired mobility, ulceration, or pruritus), oral cavity (asymptomatic to symptoms limiting oral intake), eyes (asymptomatic to severe dry eye, inability to work, or loss of vision due to keratoconjunctivitis), gastrointestinal tract (asymptomatic to significant weight loss \[\>15%\] or esophageal dilation), liver (normal function to bilirubin or enzymes \>5 times ULN), lungs (asymptomatic to severe shortness of breath requiring supplemental oxygen), joints and fascia (asymptomatic to contractures with reduced range of motion and limited ability to perform daily care), and genital tract (asymptomatic to strictures and severe pain). Subjects in the matched related donors are not included.
Outcome measures
| Measure |
Matched Related Donor
n=39 Participants
Atorvastatin will be administered at a dose of 40 mg orally daily starting on day -14, to permit an approximately 1-week observation period to rule out any acute atorvastatin-induced side effects before the initiation of transplant conditioning.
Patients will receive atorvastatin until +180 days or until the patient develops grade II-IV acute GVHD, extensive chronic GVHD, or any grade 3-4 toxicity related to atorvastatin.
Atorvastatin calcium: 40 mg PO daily
|
|---|---|
|
Matched Unrelated Donors Transplants Who Develop Grade II-IV Chronic GVHD.
|
15 Participants
|
Adverse Events
Atorvastatin Calcium (Lipitor)
Serious events: 10 serious events
Other events: 30 other events
Deaths: 0 deaths
Unrelated Donor
Serious events: 12 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Atorvastatin Calcium (Lipitor)
n=30 participants at risk
Atorvastatin will be administered at a dose of 40 mg orally daily starting on day -14, to permit an approximately 1-week observation period to rule out any acute atorvastatin-induced side effects before the initiation of transplant conditioning.
Patients will receive atorvastatin until +180 days or until the patient develops grade II-IV acute GVHD, extensive chronic GVHD, or any grade 3-4 toxicity related to atorvastatin.
Atorvastatin calcium: 40 mg PO daily
|
Unrelated Donor
n=39 participants at risk
Atorvastatin will be administered at a dose of 40 mg orally daily starting on day -14, to permit an approximately 1-week observation period to rule out any acute atorvastatin-induced side effects before the initiation of transplant conditioning.
Patients will receive atorvastatin until +180 days or until the patient develops grade II-IV acute GVHD, extensive chronic GVHD, or any grade 3-4 toxicity related to atorvastatin.
Atorvastatin calcium: 40 mg PO daily
|
|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/30 • 1 year
|
2.6%
1/39 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
6.7%
2/30 • Number of events 2 • 1 year
|
7.7%
3/39 • Number of events 3 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/30 • 1 year
|
2.6%
1/39 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/30 • 1 year
|
2.6%
1/39 • Number of events 1 • 1 year
|
|
Infections and infestations
Lung infection
|
3.3%
1/30 • Number of events 1 • 1 year
|
0.00%
0/39 • 1 year
|
|
Infections and infestations
Sepsis
|
6.7%
2/30 • Number of events 2 • 1 year
|
5.1%
2/39 • Number of events 2 • 1 year
|
|
Investigations
Bilirubin increased
|
3.3%
1/30 • Number of events 1 • 1 year
|
0.00%
0/39 • 1 year
|
|
Investigations
Neutrophil count decreased
|
3.3%
1/30 • Number of events 1 • 1 year
|
0.00%
0/39 • 1 year
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
3.3%
1/30 • Number of events 1 • 1 year
|
0.00%
0/39 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/30 • 1 year
|
2.6%
1/39 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.3%
1/30 • Number of events 1 • 1 year
|
2.6%
1/39 • Number of events 1 • 1 year
|
|
Psychiatric disorders
Delirium
|
0.00%
0/30 • 1 year
|
2.6%
1/39 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Acute kidney injury
|
3.3%
1/30 • Number of events 1 • 1 year
|
0.00%
0/39 • 1 year
|
|
Vascular disorders
Hypotension
|
0.00%
0/30 • 1 year
|
2.6%
1/39 • Number of events 1 • 1 year
|
Other adverse events
| Measure |
Atorvastatin Calcium (Lipitor)
n=30 participants at risk
Atorvastatin will be administered at a dose of 40 mg orally daily starting on day -14, to permit an approximately 1-week observation period to rule out any acute atorvastatin-induced side effects before the initiation of transplant conditioning.
Patients will receive atorvastatin until +180 days or until the patient develops grade II-IV acute GVHD, extensive chronic GVHD, or any grade 3-4 toxicity related to atorvastatin.
Atorvastatin calcium: 40 mg PO daily
|
Unrelated Donor
n=39 participants at risk
Atorvastatin will be administered at a dose of 40 mg orally daily starting on day -14, to permit an approximately 1-week observation period to rule out any acute atorvastatin-induced side effects before the initiation of transplant conditioning.
Patients will receive atorvastatin until +180 days or until the patient develops grade II-IV acute GVHD, extensive chronic GVHD, or any grade 3-4 toxicity related to atorvastatin.
Atorvastatin calcium: 40 mg PO daily
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
43.3%
13/30 • Number of events 18 • 1 year
|
59.0%
23/39 • Number of events 35 • 1 year
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
13.3%
4/30 • Number of events 4 • 1 year
|
23.1%
9/39 • Number of events 9 • 1 year
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/30 • 1 year
|
2.6%
1/39 • Number of events 1 • 1 year
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
0.00%
0/30 • 1 year
|
5.1%
2/39 • Number of events 2 • 1 year
|
|
Cardiac disorders
Pericardial effusion
|
3.3%
1/30 • Number of events 1 • 1 year
|
0.00%
0/39 • 1 year
|
|
Cardiac disorders
Supraventricular tachycardia
|
3.3%
1/30 • Number of events 1 • 1 year
|
0.00%
0/39 • 1 year
|
|
Ear and labyrinth disorders
Vestibular disorder
|
3.3%
1/30 • Number of events 1 • 1 year
|
0.00%
0/39 • 1 year
|
|
Endocrine disorders
Hypothyroidism
|
3.3%
1/30 • Number of events 1 • 1 year
|
5.1%
2/39 • Number of events 2 • 1 year
|
|
Eye disorders
Cataract
|
0.00%
0/30 • 1 year
|
2.6%
1/39 • Number of events 1 • 1 year
|
|
Eye disorders
Glaucoma
|
3.3%
1/30 • Number of events 1 • 1 year
|
2.6%
1/39 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/30 • 1 year
|
2.6%
1/39 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/30 • 1 year
|
2.6%
1/39 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Constipation
|
3.3%
1/30 • Number of events 1 • 1 year
|
0.00%
0/39 • 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
3.3%
1/30 • Number of events 1 • 1 year
|
17.9%
7/39 • Number of events 7 • 1 year
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/30 • 1 year
|
2.6%
1/39 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/30 • 1 year
|
2.6%
1/39 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Hemorrhoids
|
3.3%
1/30 • Number of events 1 • 1 year
|
0.00%
0/39 • 1 year
|
|
Gastrointestinal disorders
Mucositis oral
|
16.7%
5/30 • Number of events 5 • 1 year
|
15.4%
6/39 • Number of events 6 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
10.0%
3/30 • Number of events 3 • 1 year
|
7.7%
3/39 • Number of events 3 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
3/30 • Number of events 3 • 1 year
|
7.7%
3/39 • Number of events 3 • 1 year
|
|
General disorders
Edema limbs
|
0.00%
0/30 • 1 year
|
2.6%
1/39 • Number of events 1 • 1 year
|
|
General disorders
Fatigue
|
0.00%
0/30 • 1 year
|
2.6%
1/39 • Number of events 1 • 1 year
|
|
General disorders
Fever
|
0.00%
0/30 • 1 year
|
2.6%
1/39 • Number of events 1 • 1 year
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
3.3%
1/30 • Number of events 1 • 1 year
|
0.00%
0/39 • 1 year
|
|
General disorders
Multi-organ failure
|
0.00%
0/30 • 1 year
|
2.6%
1/39 • Number of events 1 • 1 year
|
|
General disorders
Infusion related reaction
|
3.3%
1/30 • Number of events 1 • 1 year
|
0.00%
0/39 • 1 year
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/30 • 1 year
|
2.6%
1/39 • Number of events 1 • 1 year
|
|
General disorders
Pain
|
0.00%
0/30 • 1 year
|
5.1%
2/39 • Number of events 2 • 1 year
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/30 • 1 year
|
2.6%
1/39 • Number of events 1 • 1 year
|
|
Hepatobiliary disorders
Hepatic failure
|
3.3%
1/30 • Number of events 1 • 1 year
|
0.00%
0/39 • 1 year
|
|
Immune system disorders
Anaphylaxis
|
0.00%
0/30 • 1 year
|
2.6%
1/39 • Number of events 1 • 1 year
|
|
Immune system disorders
Pollen allergy
|
3.3%
1/30 • Number of events 1 • 1 year
|
0.00%
0/39 • 1 year
|
|
Infections and infestations
Catheter related infection
|
3.3%
1/30 • Number of events 1 • 1 year
|
0.00%
0/39 • 1 year
|
|
Infections and infestations
Endocarditis infective
|
3.3%
1/30 • Number of events 1 • 1 year
|
0.00%
0/39 • 1 year
|
|
Infections and infestations
Hepatitis viral
|
3.3%
1/30 • Number of events 1 • 1 year
|
2.6%
1/39 • Number of events 1 • 1 year
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/30 • 1 year
|
2.6%
1/39 • Number of events 1 • 1 year
|
|
Infections and infestations
Scabies
|
3.3%
1/30 • Number of events 1 • 1 year
|
0.00%
0/39 • 1 year
|
|
Infections and infestations
Skin infection
|
6.7%
2/30 • Number of events 2 • 1 year
|
0.00%
0/39 • 1 year
|
|
Infections and infestations
Influenza
|
3.3%
1/30 • Number of events 1 • 1 year
|
0.00%
0/39 • 1 year
|
|
Infections and infestations
Small intestine infection
|
3.3%
1/30 • Number of events 1 • 1 year
|
0.00%
0/39 • 1 year
|
|
Infections and infestations
Large intestine infection
|
3.3%
1/30 • Number of events 1 • 1 year
|
10.3%
4/39 • Number of events 4 • 1 year
|
|
Infections and infestations
Multiple drug resistant infection
|
3.3%
1/30 • Number of events 1 • 1 year
|
0.00%
0/39 • 1 year
|
|
Infections and infestations
Lung infection
|
0.00%
0/30 • 1 year
|
2.6%
1/39 • Number of events 1 • 1 year
|
|
Infections and infestations
Otitis externa
|
3.3%
1/30 • Number of events 1 • 1 year
|
0.00%
0/39 • 1 year
|
|
Infections and infestations
Sepsis
|
10.0%
3/30 • Number of events 3 • 1 year
|
20.5%
8/39 • Number of events 8 • 1 year
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
3.3%
1/30 • Number of events 1 • 1 year
|
0.00%
0/39 • 1 year
|
|
Injury, poisoning and procedural complications
Foot fracture
|
3.3%
1/30 • Number of events 1 • 1 year
|
0.00%
0/39 • 1 year
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/30 • 1 year
|
2.6%
1/39 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
0.00%
0/30 • 1 year
|
2.6%
1/39 • Number of events 1 • 1 year
|
|
Investigations
Alanine aminotransferase increased
|
16.7%
5/30 • Number of events 7 • 1 year
|
10.3%
4/39 • Number of events 7 • 1 year
|
|
Investigations
Alkaline phosphatase increased
|
10.0%
3/30 • Number of events 3 • 1 year
|
12.8%
5/39 • Number of events 6 • 1 year
|
|
Investigations
Blood bilirubin increased
|
3.3%
1/30 • Number of events 1 • 1 year
|
5.1%
2/39 • Number of events 2 • 1 year
|
|
Investigations
Cholesterol high
|
3.3%
1/30 • Number of events 1 • 1 year
|
5.1%
2/39 • Number of events 2 • 1 year
|
|
Investigations
Creatinine increased
|
6.7%
2/30 • Number of events 2 • 1 year
|
7.7%
3/39 • Number of events 3 • 1 year
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
3.3%
1/30 • Number of events 1 • 1 year
|
0.00%
0/39 • 1 year
|
|
Investigations
Dyslipidemia
|
3.3%
1/30 • Number of events 1 • 1 year
|
0.00%
0/39 • 1 year
|
|
Investigations
Ferritin increased
|
3.3%
1/30 • Number of events 3 • 1 year
|
10.3%
4/39 • Number of events 4 • 1 year
|
|
Investigations
Lactate dehydrogenase increased
|
13.3%
4/30 • Number of events 4 • 1 year
|
17.9%
7/39 • Number of events 7 • 1 year
|
|
Investigations
Red blood cell count decreased
|
36.7%
11/30 • Number of events 11 • 1 year
|
28.2%
11/39 • Number of events 11 • 1 year
|
|
Investigations
Chloride increased
|
16.7%
5/30 • Number of events 5 • 1 year
|
10.3%
4/39 • Number of events 4 • 1 year
|
|
Investigations
Blood urea nitrogen increased
|
3.3%
1/30 • Number of events 1 • 1 year
|
2.6%
1/39 • Number of events 1 • 1 year
|
|
Investigations
Total protein decreased
|
3.3%
1/30 • Number of events 1 • 1 year
|
15.4%
6/39 • Number of events 6 • 1 year
|
|
Investigations
Lactate dehydrogenase decreased
|
0.00%
0/30 • 1 year
|
7.7%
3/39 • Number of events 3 • 1 year
|
|
Investigations
Hematocrit decreased
|
0.00%
0/30 • 1 year
|
2.6%
1/39 • Number of events 1 • 1 year
|
|
Investigations
Hypercholesterolemia
|
3.3%
1/30 • Number of events 1 • 1 year
|
0.00%
0/39 • 1 year
|
|
Investigations
Monocyte count decreased
|
3.3%
1/30 • Number of events 1 • 1 year
|
5.1%
2/39 • Number of events 2 • 1 year
|
|
Investigations
Monocyte count increased
|
3.3%
1/30 • Number of events 1 • 1 year
|
5.1%
2/39 • Number of events 2 • 1 year
|
|
Investigations
Red blood cell count increased
|
3.3%
1/30 • Number of events 1 • 1 year
|
0.00%
0/39 • 1 year
|
|
Investigations
Chloride decreased
|
3.3%
1/30 • Number of events 1 • 1 year
|
0.00%
0/39 • 1 year
|
|
Investigations
Bicarbonate decreased
|
3.3%
1/30 • Number of events 1 • 1 year
|
2.6%
1/39 • Number of events 1 • 1 year
|
|
Investigations
Blood Urea Nitrogen decreased
|
3.3%
1/30 • Number of events 1 • 1 year
|
0.00%
0/39 • 1 year
|
|
Investigations
Eosinophils decreased
|
0.00%
0/30 • 1 year
|
2.6%
1/39 • Number of events 1 • 1 year
|
|
Investigations
Anion gap high
|
0.00%
0/30 • 1 year
|
2.6%
1/39 • Number of events 1 • 1 year
|
|
Investigations
Alkaline phosphatase decreased
|
0.00%
0/30 • 1 year
|
2.6%
1/39 • Number of events 1 • 1 year
|
|
Investigations
Lipase increased
|
0.00%
0/30 • 1 year
|
2.6%
1/39 • Number of events 1 • 1 year
|
|
Investigations
Lymphocyte count decreased
|
50.0%
15/30 • Number of events 15 • 1 year
|
35.9%
14/39 • Number of events 14 • 1 year
|
|
Investigations
Neutrophil count decreased
|
56.7%
17/30 • Number of events 17 • 1 year
|
43.6%
17/39 • Number of events 17 • 1 year
|
|
Investigations
Platelet count decreased
|
46.7%
14/30 • Number of events 14 • 1 year
|
38.5%
15/39 • Number of events 15 • 1 year
|
|
Metabolism and nutrition disorders
Anorexia
|
50.0%
15/30 • Number of events 15 • 1 year
|
43.6%
17/39 • Number of events 17 • 1 year
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/30 • 1 year
|
5.1%
2/39 • Number of events 2 • 1 year
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
33.3%
10/30 • Number of events 10 • 1 year
|
30.8%
12/39 • Number of events 12 • 1 year
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/30 • 1 year
|
5.1%
2/39 • Number of events 2 • 1 year
|
|
Metabolism and nutrition disorders
Hypernatremia
|
3.3%
1/30 • Number of events 1 • 1 year
|
0.00%
0/39 • 1 year
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
3.3%
1/30 • Number of events 1 • 1 year
|
0.00%
0/39 • 1 year
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
6.7%
2/30 • Number of events 2 • 1 year
|
15.4%
6/39 • Number of events 6 • 1 year
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
3.3%
1/30 • Number of events 1 • 1 year
|
7.7%
3/39 • Number of events 3 • 1 year
|
|
Metabolism and nutrition disorders
Hypokalemia
|
10.0%
3/30 • Number of events 3 • 1 year
|
7.7%
3/39 • Number of events 3 • 1 year
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/30 • 1 year
|
2.6%
1/39 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/30 • 1 year
|
10.3%
4/39 • Number of events 4 • 1 year
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
10.0%
3/30 • Number of events 3 • 1 year
|
10.3%
4/39 • Number of events 4 • 1 year
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/30 • 1 year
|
15.4%
6/39 • Number of events 6 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
6.7%
2/30 • Number of events 2 • 1 year
|
5.1%
2/39 • Number of events 2 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.3%
1/30 • Number of events 1 • 1 year
|
2.6%
1/39 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
3.3%
1/30 • Number of events 1 • 1 year
|
0.00%
0/39 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased lumbar spine
|
3.3%
1/30 • Number of events 1 • 1 year
|
0.00%
0/39 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Drug-induced myopathy
|
3.3%
1/30 • Number of events 1 • 1 year
|
0.00%
0/39 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/30 • 1 year
|
10.3%
4/39 • Number of events 4 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
6.7%
2/30 • Number of events 2 • 1 year
|
0.00%
0/39 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/30 • 1 year
|
2.6%
1/39 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Uterine polyps
|
3.3%
1/30 • Number of events 1 • 1 year
|
0.00%
0/39 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Benign prostatic hyperplasia
|
3.3%
1/30 • Number of events 1 • 1 year
|
0.00%
0/39 • 1 year
|
|
Nervous system disorders
Dizziness
|
0.00%
0/30 • 1 year
|
2.6%
1/39 • Number of events 1 • 1 year
|
|
Nervous system disorders
Headache
|
0.00%
0/30 • 1 year
|
5.1%
2/39 • Number of events 2 • 1 year
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
6.7%
2/30 • Number of events 2 • 1 year
|
2.6%
1/39 • Number of events 2 • 1 year
|
|
Nervous system disorders
Syncope
|
0.00%
0/30 • 1 year
|
2.6%
1/39 • Number of events 1 • 1 year
|
|
Psychiatric disorders
Anxiety
|
6.7%
2/30 • Number of events 2 • 1 year
|
10.3%
4/39 • Number of events 4 • 1 year
|
|
Psychiatric disorders
Depression
|
3.3%
1/30 • Number of events 1 • 1 year
|
12.8%
5/39 • Number of events 5 • 1 year
|
|
Renal and urinary disorders
Acute kidney injury
|
13.3%
4/30 • Number of events 4 • 1 year
|
0.00%
0/39 • 1 year
|
|
Renal and urinary disorders
Chronic kidney disease
|
3.3%
1/30 • Number of events 1 • 1 year
|
0.00%
0/39 • 1 year
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/30 • 1 year
|
2.6%
1/39 • Number of events 1 • 1 year
|
|
Infections and infestations
Kidney infection
|
0.00%
0/30 • 1 year
|
7.7%
3/39 • Number of events 3 • 1 year
|
|
Renal and urinary disorders
Renal calculi
|
0.00%
0/30 • 1 year
|
2.6%
1/39 • Number of events 1 • 1 year
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
3.3%
1/30 • Number of events 1 • 1 year
|
5.1%
2/39 • Number of events 2 • 1 year
|
|
Infections and infestations
Breast infection
|
3.3%
1/30 • Number of events 1 • 1 year
|
0.00%
0/39 • 1 year
|
|
Reproductive system and breast disorders
Premature menopause
|
3.3%
1/30 • Number of events 1 • 1 year
|
0.00%
0/39 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
3.3%
1/30 • Number of events 1 • 1 year
|
0.00%
0/39 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/30 • 1 year
|
5.1%
2/39 • Number of events 2 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/30 • 1 year
|
5.1%
2/39 • Number of events 2 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/30 • 1 year
|
12.8%
5/39 • Number of events 5 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/30 • 1 year
|
2.6%
1/39 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/30 • 1 year
|
2.6%
1/39 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/30 • 1 year
|
2.6%
1/39 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/30 • 1 year
|
2.6%
1/39 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
6.7%
2/30 • Number of events 2 • 1 year
|
7.7%
3/39 • Number of events 3 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
3.3%
1/30 • Number of events 1 • 1 year
|
0.00%
0/39 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Chronic occlusive pulmonary disease
|
0.00%
0/30 • 1 year
|
2.6%
1/39 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
3.3%
1/30 • Number of events 1 • 1 year
|
2.6%
1/39 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
6.7%
2/30 • Number of events 2 • 1 year
|
5.1%
2/39 • Number of events 2 • 1 year
|
|
Surgical and medical procedures
Appendectomy
|
3.3%
1/30 • Number of events 1 • 1 year
|
5.1%
2/39 • Number of events 2 • 1 year
|
|
Surgical and medical procedures
Cholesystectomy
|
0.00%
0/30 • 1 year
|
2.6%
1/39 • Number of events 1 • 1 year
|
|
Surgical and medical procedures
Cardiac stent placed
|
0.00%
0/30 • 1 year
|
2.6%
1/39 • Number of events 1 • 1 year
|
|
Surgical and medical procedures
Nissen fundoplication
|
0.00%
0/30 • 1 year
|
2.6%
1/39 • Number of events 1 • 1 year
|
|
Surgical and medical procedures
Skin grafts trunk arm leg 100 cm^2 or less
|
0.00%
0/30 • 1 year
|
2.6%
1/39 • Number of events 1 • 1 year
|
|
Surgical and medical procedures
Inferior vena cava filter placed
|
0.00%
0/30 • 1 year
|
2.6%
1/39 • Number of events 1 • 1 year
|
|
Vascular disorders
Hypertension
|
23.3%
7/30 • Number of events 7 • 1 year
|
25.6%
10/39 • Number of events 11 • 1 year
|
|
Vascular disorders
Hypotension
|
0.00%
0/30 • 1 year
|
7.7%
3/39 • Number of events 3 • 1 year
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/30 • 1 year
|
12.8%
5/39 • Number of events 5 • 1 year
|
|
Metabolism and nutrition disorders
Gout
|
6.7%
2/30 • Number of events 2 • 1 year
|
0.00%
0/39 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place