Trial Outcomes & Findings for BLAST MRD AML-2: BLockade of PD-1 Added to Standard Therapy to Target Measurable Residual Disease in Acute Myeloid Leukemia 2- A Randomized Phase 2 Study of Anti-PD-1 Pembrolizumab in Combination With Azacitidine and Venetoclax as Frontline Therapy in Unfit Patients With Acute Myeloid Leukemia (NCT NCT04284787)
NCT ID: NCT04284787
Last Updated: 2025-08-03
Results Overview
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
Up to 6 cycles (each cycle is 28 days)
Results posted on
2025-08-03
Participant Flow
Participant milestones
| Measure |
Arm I (AZA, VEN)
See Detailed Description
Azacitidine: Given IV or SC
Biopsy: Undergo biopsy
Biospecimen Collection: Undergo blood specimen collection
Bone Marrow Aspiration: Undergo bone marrow aspiration
Bone Marrow Biopsy: Undergo bone marrow biopsy
Echocardiography: Undergo ECHO
Multigated Acquisition Scan: Undergo MUGA scan
Venetoclax: Given PO
|
Arm II (AZA, VEN, Pembrolizumab)
See Detailed Description
Azacitidine: Given IV or SC
Biopsy: Undergo biopsy
Biospecimen Collection: Undergo blood specimen collection
Bone Marrow Aspiration: Undergo bone marrow aspiration
Bone Marrow Biopsy: Undergo bone marrow biopsy
Echocardiography: Undergo ECHO
Multigated Acquisition Scan: Undergo MUGA scan
Pembrolizumab: Given IV
Venetoclax: Given PO
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
29
|
|
Overall Study
Received Trial Therapy
|
29
|
29
|
|
Overall Study
Completed Trial Therapy
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
31
|
29
|
Reasons for withdrawal
| Measure |
Arm I (AZA, VEN)
See Detailed Description
Azacitidine: Given IV or SC
Biopsy: Undergo biopsy
Biospecimen Collection: Undergo blood specimen collection
Bone Marrow Aspiration: Undergo bone marrow aspiration
Bone Marrow Biopsy: Undergo bone marrow biopsy
Echocardiography: Undergo ECHO
Multigated Acquisition Scan: Undergo MUGA scan
Venetoclax: Given PO
|
Arm II (AZA, VEN, Pembrolizumab)
See Detailed Description
Azacitidine: Given IV or SC
Biopsy: Undergo biopsy
Biospecimen Collection: Undergo blood specimen collection
Bone Marrow Aspiration: Undergo bone marrow aspiration
Bone Marrow Biopsy: Undergo bone marrow biopsy
Echocardiography: Undergo ECHO
Multigated Acquisition Scan: Undergo MUGA scan
Pembrolizumab: Given IV
Venetoclax: Given PO
|
|---|---|---|
|
Overall Study
Disease Progression
|
9
|
12
|
|
Overall Study
Physician Decision
|
12
|
7
|
|
Overall Study
Transplant
|
5
|
4
|
|
Overall Study
Death
|
1
|
2
|
|
Overall Study
Adverse Event
|
0
|
4
|
|
Overall Study
Non-adherence
|
2
|
0
|
|
Overall Study
Lack of Efficacy
|
2
|
0
|
Baseline Characteristics
BLAST MRD AML-2: BLockade of PD-1 Added to Standard Therapy to Target Measurable Residual Disease in Acute Myeloid Leukemia 2- A Randomized Phase 2 Study of Anti-PD-1 Pembrolizumab in Combination With Azacitidine and Venetoclax as Frontline Therapy in Unfit Patients With Acute Myeloid Leukemia
Baseline characteristics by cohort
| Measure |
Arm I (AZA, VEN)
n=29 Participants
See Detailed Description
Azacitidine: Given IV or SC
Biopsy: Undergo biopsy
Biospecimen Collection: Undergo blood specimen collection
Bone Marrow Aspiration: Undergo bone marrow aspiration
Bone Marrow Biopsy: Undergo bone marrow biopsy
Echocardiography: Undergo ECHO
Multigated Acquisition Scan: Undergo MUGA scan
Venetoclax: Given PO
|
Arm II (AZA, VEN, Pembrolizumab)
n=29 Participants
See Detailed Description
Azacitidine: Given IV or SC
Biopsy: Undergo biopsy
Biospecimen Collection: Undergo blood specimen collection
Bone Marrow Aspiration: Undergo bone marrow aspiration
Bone Marrow Biopsy: Undergo bone marrow biopsy
Echocardiography: Undergo ECHO
Multigated Acquisition Scan: Undergo MUGA scan
Pembrolizumab: Given IV
Venetoclax: Given PO
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
73 years
n=5 Participants
|
74 years
n=7 Participants
|
73.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
38 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
|
2 Participants
n=5 Participants
|
0 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
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
48 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
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=5 Participants
|
29 participants
n=7 Participants
|
58 participants
n=5 Participants
|
|
ECOG PS
0
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
ECOG PS
1
|
19 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
ECOG PS
2
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
ECOG PS
MISSING
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
ELN 2022 risk
Favorable
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
ELN 2022 risk
Intermediate
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
ELN 2022 risk
Adverse
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Clinically Relevant Mutations
TP53
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Clinically Relevant Mutations
NPM1
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Clinically Relevant Mutations
KRAS/NRAS
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Clinically Relevant Mutations
FLT3
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Clinically Relevant Mutations
Secondary ontogeny
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Clinically Relevant Mutations
Missing
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 6 cycles (each cycle is 28 days)Population: Safety population
Outcome measures
| Measure |
Arm I (AZA, VEN)
n=29 Participants
See Detailed Description
Azacitidine: Given IV or SC
Biopsy: Undergo biopsy
Biospecimen Collection: Undergo blood specimen collection
Bone Marrow Aspiration: Undergo bone marrow aspiration
Bone Marrow Biopsy: Undergo bone marrow biopsy
Echocardiography: Undergo ECHO
Multigated Acquisition Scan: Undergo MUGA scan
Venetoclax: Given PO
|
Arm II (AZA, VEN, Pembrolizumab)
n=29 Participants
See Detailed Description
Azacitidine: Given IV or SC
Biopsy: Undergo biopsy
Biospecimen Collection: Undergo blood specimen collection
Bone Marrow Aspiration: Undergo bone marrow aspiration
Bone Marrow Biopsy: Undergo bone marrow biopsy
Echocardiography: Undergo ECHO
Multigated Acquisition Scan: Undergo MUGA scan
Pembrolizumab: Given IV
Venetoclax: Given PO
|
|---|---|---|
|
Percentage of Patients With Minimal Residual Disease Negative Complete Remission (MRD-CR) or MRD-complete Remission With Incomplete Count Recovery (Cri) With Azacitidine (AZA) + Venetoclax (VEN) With MK-3475 (Pembrolizumab)
MRD-negative CR/CRi
|
13 Participants
|
13 Participants
|
|
Percentage of Patients With Minimal Residual Disease Negative Complete Remission (MRD-CR) or MRD-complete Remission With Incomplete Count Recovery (Cri) With Azacitidine (AZA) + Venetoclax (VEN) With MK-3475 (Pembrolizumab)
MRD-negative CR
|
7 Participants
|
7 Participants
|
|
Percentage of Patients With Minimal Residual Disease Negative Complete Remission (MRD-CR) or MRD-complete Remission With Incomplete Count Recovery (Cri) With Azacitidine (AZA) + Venetoclax (VEN) With MK-3475 (Pembrolizumab)
No MRD-negative CR/CRi or lack thereof
|
9 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Up to cycle 2 (each cycle is 28 days)Population: the first 6 participants were assessed for severe pembrolizumab related toxicity, 1 participant was not evaluable.
Outcome measures
| Measure |
Arm I (AZA, VEN)
n=5 Participants
See Detailed Description
Azacitidine: Given IV or SC
Biopsy: Undergo biopsy
Biospecimen Collection: Undergo blood specimen collection
Bone Marrow Aspiration: Undergo bone marrow aspiration
Bone Marrow Biopsy: Undergo bone marrow biopsy
Echocardiography: Undergo ECHO
Multigated Acquisition Scan: Undergo MUGA scan
Venetoclax: Given PO
|
Arm II (AZA, VEN, Pembrolizumab)
See Detailed Description
Azacitidine: Given IV or SC
Biopsy: Undergo biopsy
Biospecimen Collection: Undergo blood specimen collection
Bone Marrow Aspiration: Undergo bone marrow aspiration
Bone Marrow Biopsy: Undergo bone marrow biopsy
Echocardiography: Undergo ECHO
Multigated Acquisition Scan: Undergo MUGA scan
Pembrolizumab: Given IV
Venetoclax: Given PO
|
|---|---|---|
|
Proportion of Patients Who Develop Severe Toxicity
|
0 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to 3 yearsA univariate logistic regression will be selected to assess baseline biomarkers associated with response outcomes. The dynamic changes of PD-L1/ PD-1 expressions, concentration of cytokine, and ribonucleic acid sequencing (seq)/T-cell receptor seq etc. will be monitored. The measurements of biomarkers in changes over time from baseline to several time-points will be performed by using generalized linear mixed effects modeling with a Benjamini-Hochberg correction to control for false discovery rates.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to 3 yearsThe Kaplan-Meier method and log-rank test will be used to estimate the distribution of survival between/among different marker strata. Univariate or Multivariate cox proportional hazard models will be employed to explore the significance of biomarkers on survival outcomes, while adjusting for the potential prognostic factors. The interaction effects between treatment and biomarkers also will be evaluated. Serial measurements of biomarkers will be estimated at baseline, end of induction, post-cycle 1, 2, 4, and 6, every 3 months during maintenance, one year, and end of treatment when applicable. Landmark analysis or joint modeling will be used to assess serial measurements of biomarkers dynamical impacts on survival outcomes, where appropriate.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 3 yearsThe associations between treatment arms and baseline biomarkers will be evaluated using Chi-squared test/ Fisher's exact test, analysis of variance and the Mann-Whitney U tests as appropriate. Trajectory trends of the changes in markers' values or status across the measurement time will be explored using generalized linear mixed models. The bar plots and trajectory time plots will visually show the differences over time between treatment arms. The associations between markers and the demographic/prognostic factors will also be assessed using the similar statistical methods.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 3 yearsThe correlations between biomarkers will be evaluated using Pearson/Spearman rank-order correlation coefficients, Chi-squared/Fisher's exact tests, and Wilcoxon rank sun / Kruskal-Wallis tests as appropriate. A scatter plot, boxplot, and mosaic plot will also be generated for visualization. The multiplicity of the endpoints will be adjusted using the correction of Benjamini and Hochberg.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 3 yearsLibrary preparation, sequencing, and analysis will be performed with TwinStrand's optimized workflow, and TwinStrand's bioinformatics core will perform all analyses related to assay output.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At day 30 (after administration of pembrolizumab and count recovery) and after cycles 2, 4, and 6 (each cycle is 28 days)IFN-gamma+/CD3+/ CD4+ or IFN-gamma+/CD3+/CD8+ events will be gated and percentages of the total CD4+ and CD8+ T cells will be determined. Will compare levels of leukemia specific T-cell.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At day 14 and at time of count recoveryAn association of clinical response with the expression of PD-L1 AML BM cells will be assessed by a Pearson chi-square test on a 2x2 table of frequencies.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to cycle 6 (each cycle is 28 days)Statistical analyses of the frequency of CD8+, CD4+, Foxp3 regulatory T cells, CD8+/Foxp3+ Tregs, central memory T cell/effector memory T cell re-expressed CD45RA (TEMRA), effector memory T cell/TEMRA, the percentage of Ki67 and GzmB in PD-1+, Eomes+ CD8 T cells to compare changes over time from baseline to several time-points will be performed by using mixed effects modeling with a Benjamini-Hochberg correction to control for false discovery rates.
Outcome measures
Outcome data not reported
Adverse Events
Arm I (AZA, VEN)
Serious events: 28 serious events
Other events: 26 other events
Deaths: 18 deaths
Arm II (AZA, VEN, Pembrolizumab)
Serious events: 29 serious events
Other events: 26 other events
Deaths: 22 deaths
Serious adverse events
| Measure |
Arm I (AZA, VEN)
n=29 participants at risk
See Detailed Description
Azacitidine: Given IV or SC
Biopsy: Undergo biopsy
Biospecimen Collection: Undergo blood specimen collection
Bone Marrow Aspiration: Undergo bone marrow aspiration
Bone Marrow Biopsy: Undergo bone marrow biopsy
Echocardiography: Undergo ECHO
Multigated Acquisition Scan: Undergo MUGA scan
Venetoclax: Given PO
|
Arm II (AZA, VEN, Pembrolizumab)
n=29 participants at risk
See Detailed Description
Azacitidine: Given IV or SC
Biopsy: Undergo biopsy
Biospecimen Collection: Undergo blood specimen collection
Bone Marrow Aspiration: Undergo bone marrow aspiration
Bone Marrow Biopsy: Undergo bone marrow biopsy
Echocardiography: Undergo ECHO
Multigated Acquisition Scan: Undergo MUGA scan
Pembrolizumab: Given IV
Venetoclax: Given PO
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
37.9%
11/29 • Up to 2 years
|
31.0%
9/29 • Up to 2 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
27.6%
8/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/29 • Up to 2 years
|
10.3%
3/29 • Up to 2 years
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
General disorders
Death NOS
|
3.4%
1/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
General disorders
Disease progression
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
General disorders
Fatigue
|
3.4%
1/29 • Up to 2 years
|
6.9%
2/29 • Up to 2 years
|
|
General disorders
Fever
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
General disorders
General and admin site - Other - Volume overload
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Gastrointestinal disorders
Abdominal pain
|
3.4%
1/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Gastrointestinal disorders
Colonic perforation
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/29 • Up to 2 years
|
10.3%
3/29 • Up to 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
3.4%
1/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Gastrointestinal disorders
Esophagitis
|
3.4%
1/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Gastrointestinal disorders
GI disorders - Other, specify - Diverticular abscess
|
0.00%
0/29 • Up to 2 years
|
6.9%
2/29 • Up to 2 years
|
|
Gastrointestinal disorders
GI disorders - Other, specify - Diverticulitis
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Gastrointestinal disorders
Mucositis oral
|
6.9%
2/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
3.4%
1/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Gastrointestinal disorders
Vomiting
|
3.4%
1/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other - Choledocholithiasis
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Infections and infestations
Infections & infestations - Other - COVID 19 Infection
|
0.00%
0/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Infections and infestations
Infections & infestations - Other - Sepsis
|
3.4%
1/29 • Up to 2 years
|
24.1%
7/29 • Up to 2 years
|
|
Infections and infestations
Lung infection
|
10.3%
3/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Infections and infestations
Pelvic infection
|
0.00%
0/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Infections and infestations
Pharyngitis
|
3.4%
1/29 • Up to 2 years
|
6.9%
2/29 • Up to 2 years
|
|
Infections and infestations
Sepsis
|
6.9%
2/29 • Up to 2 years
|
6.9%
2/29 • Up to 2 years
|
|
Infections and infestations
Skin infection
|
3.4%
1/29 • Up to 2 years
|
6.9%
2/29 • Up to 2 years
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/29 • Up to 2 years
|
13.8%
4/29 • Up to 2 years
|
|
Investigations
ALT increased
|
0.00%
0/29 • Up to 2 years
|
13.8%
4/29 • Up to 2 years
|
|
Investigations
AST increased
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Investigations
Cardiac troponin I increased
|
0.00%
0/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Investigations
EKG QT corrected interval prolong
|
3.4%
1/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Investigations
Fibrinogen decreased
|
0.00%
0/29 • Up to 2 years
|
62.1%
18/29 • Up to 2 years
|
|
Investigations
Lymphocyte count decreased
|
48.3%
14/29 • Up to 2 years
|
72.4%
21/29 • Up to 2 years
|
|
Investigations
Neutrophil count decreased
|
65.5%
19/29 • Up to 2 years
|
65.5%
19/29 • Up to 2 years
|
|
Investigations
Platelet count decreased
|
51.7%
15/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Investigations
Weight loss
|
3.4%
1/29 • Up to 2 years
|
82.8%
24/29 • Up to 2 years
|
|
Investigations
White blood cell decreased
|
82.8%
24/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Metabolism and nutrition disorders
Acidosis
|
3.4%
1/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
3.4%
1/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.00%
0/29 • Up to 2 years
|
10.3%
3/29 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
3.4%
1/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskel/connect tissue -Other - Knee effusion (hemarthrosis)
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
3.4%
1/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms - Other - AML disease progression
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms - Other - AML progression
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms - Other - peripheral blasts
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Nervous system disorders
Headache
|
0.00%
0/29 • Up to 2 years
|
13.8%
4/29 • Up to 2 years
|
|
Nervous system disorders
Syncope
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Psychiatric disorders
Delirium
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Reproductive system and breast disorders
Genital edema
|
3.4%
1/29 • Up to 2 years
|
6.9%
2/29 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/29 • Up to 2 years
|
10.3%
3/29 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.4%
1/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic & mediast - Other - Lung Nodules
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
3.4%
1/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
3.4%
1/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Surgical and medical procedures
Surgical and medical - Other - knee ablation
|
3.4%
1/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Vascular disorders
Hematoma
|
0.00%
0/29 • Up to 2 years
|
6.9%
2/29 • Up to 2 years
|
|
Vascular disorders
Hypertension
|
3.4%
1/29 • Up to 2 years
|
17.2%
5/29 • Up to 2 years
|
|
Vascular disorders
Hypotension
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
Other adverse events
| Measure |
Arm I (AZA, VEN)
n=29 participants at risk
See Detailed Description
Azacitidine: Given IV or SC
Biopsy: Undergo biopsy
Biospecimen Collection: Undergo blood specimen collection
Bone Marrow Aspiration: Undergo bone marrow aspiration
Bone Marrow Biopsy: Undergo bone marrow biopsy
Echocardiography: Undergo ECHO
Multigated Acquisition Scan: Undergo MUGA scan
Venetoclax: Given PO
|
Arm II (AZA, VEN, Pembrolizumab)
n=29 participants at risk
See Detailed Description
Azacitidine: Given IV or SC
Biopsy: Undergo biopsy
Biospecimen Collection: Undergo blood specimen collection
Bone Marrow Aspiration: Undergo bone marrow aspiration
Bone Marrow Biopsy: Undergo bone marrow biopsy
Echocardiography: Undergo ECHO
Multigated Acquisition Scan: Undergo MUGA scan
Pembrolizumab: Given IV
Venetoclax: Given PO
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
55.2%
16/29 • Up to 2 years
|
69.0%
20/29 • Up to 2 years
|
|
Blood and lymphatic system disorders
Blood/Lymph - Other - idiopathic thrombocytopenic purpura
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Blood and lymphatic system disorders
Blood/Lymph - Other - Pancytopenia
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Blood and lymphatic system disorders
Blood/Lymph - Other - Thryoiditis
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
13.8%
4/29 • Up to 2 years
|
34.5%
10/29 • Up to 2 years
|
|
Blood and lymphatic system disorders
Lymph node pain
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/29 • Up to 2 years
|
13.8%
4/29 • Up to 2 years
|
|
Cardiac disorders
Atrial flutter
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Cardiac disorders
Cardiac disorders - Other - Coronary Artery Disease
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Cardiac disorders
Cardiac disorders - Other - Murmur
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Cardiac disorders
Cardiac disorders - Other - tachycardia nos
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Cardiac disorders
Cardiac disorders - Other - tachycardia NOS
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Cardiac disorders
Heart failure
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Cardiac disorders
Palpitations
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Cardiac disorders
Paroxysmal atrial tachycardia
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Cardiac disorders
Sinus bradycardia
|
3.4%
1/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Cardiac disorders
Sinus tachycardia
|
20.7%
6/29 • Up to 2 years
|
6.9%
2/29 • Up to 2 years
|
|
Cardiac disorders
Supraventricular tachycardia
|
6.9%
2/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Ear and labyrinth disorders
Ear and Labyrinth - Other - ear fullness
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Ear and labyrinth disorders
Hearing impaired
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Endocrine disorders
Endocrine disorders - Other - Euthyroid Sick Syndrome
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Endocrine disorders
Endocrine disorders - Other - Hypervolemia
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Endocrine disorders
Hyperthyroidism
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Endocrine disorders
Hypothyroidism
|
3.4%
1/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Eye disorders
Blurred vision
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Eye disorders
Cataract
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Eye disorders
Dry eye
|
3.4%
1/29 • Up to 2 years
|
6.9%
2/29 • Up to 2 years
|
|
Eye disorders
Eye disorders - Other, specify - Blepharitis
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Eye disorders
Eye disorders - Other, specify - Bloodshot eyes / minor hemorrhage
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Eye disorders
Eye disorders - Other, specify - conjuctivitis
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Eye disorders
Eye disorders - Other, specify - erythema of left eye
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Eye disorders
Eye disorders - Other, specify - pruritus of left eye
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Eye disorders
Eye disorders - Other, specify - Rt Eye Stye
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Eye disorders
Eye disorders - Other, specify - superficial punctuate epithelial erosions bilateral eyes
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Eye disorders
Eye pain
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Eye disorders
Floaters
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Eye disorders
Retinal vascular disorder
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Eye disorders
Scleral disorder
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
General disorders
Chills
|
13.8%
4/29 • Up to 2 years
|
17.2%
5/29 • Up to 2 years
|
|
General disorders
Edema face
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
General disorders
Edema limbs
|
17.2%
5/29 • Up to 2 years
|
37.9%
11/29 • Up to 2 years
|
|
General disorders
Fatigue
|
34.5%
10/29 • Up to 2 years
|
41.4%
12/29 • Up to 2 years
|
|
General disorders
Fever
|
17.2%
5/29 • Up to 2 years
|
27.6%
8/29 • Up to 2 years
|
|
General disorders
General and admin site - Other - bilateral forearm flaking
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
General disorders
General and admin site - Other - bilateral forearm redness
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
General disorders
General and admin site - Other - Gum Pain
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
General disorders
General and admin site - Other - temperature increased
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
General disorders
General and admin site - Other - vaccine reaction
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
General disorders
Generalized edema
|
6.9%
2/29 • Up to 2 years
|
10.3%
3/29 • Up to 2 years
|
|
General disorders
Injection site reaction
|
6.9%
2/29 • Up to 2 years
|
6.9%
2/29 • Up to 2 years
|
|
General disorders
Malaise
|
3.4%
1/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
General disorders
Neck edema
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
General disorders
Non-cardiac chest pain
|
3.4%
1/29 • Up to 2 years
|
10.3%
3/29 • Up to 2 years
|
|
General disorders
Pain
|
6.9%
2/29 • Up to 2 years
|
10.3%
3/29 • Up to 2 years
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Gastrointestinal disorders
Abdominal pain
|
6.9%
2/29 • Up to 2 years
|
13.8%
4/29 • Up to 2 years
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Gastrointestinal disorders
Anal pain
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Gastrointestinal disorders
Colitis
|
3.4%
1/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Gastrointestinal disorders
Colonic perforation
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Gastrointestinal disorders
Constipation
|
48.3%
14/29 • Up to 2 years
|
58.6%
17/29 • Up to 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
41.4%
12/29 • Up to 2 years
|
48.3%
14/29 • Up to 2 years
|
|
Gastrointestinal disorders
Dry mouth
|
6.9%
2/29 • Up to 2 years
|
10.3%
3/29 • Up to 2 years
|
|
Gastrointestinal disorders
Dysphagia
|
6.9%
2/29 • Up to 2 years
|
10.3%
3/29 • Up to 2 years
|
|
Gastrointestinal disorders
Esophagitis
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Gastrointestinal disorders
Fecal incontinence
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Gastrointestinal disorders
Flatulence
|
10.3%
3/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
10.3%
3/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Gastrointestinal disorders
GI disorders - Other, specify - blood in stool
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Gastrointestinal disorders
GI disorders - Other, specify - Diverticulitis
|
0.00%
0/29 • Up to 2 years
|
6.9%
2/29 • Up to 2 years
|
|
Gastrointestinal disorders
GI disorders - Other, specify - Early Satiety
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Gastrointestinal disorders
GI disorders - Other, specify - GI Bleed
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Gastrointestinal disorders
GI disorders - Other, specify - left lip lesion NOS
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Gastrointestinal disorders
GI disorders - Other, specify - malnutrition
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Gastrointestinal disorders
GI disorders - Other, specify - melena
|
3.4%
1/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Gastrointestinal disorders
GI disorders - Other, specify - pancreatic lesions
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Gastrointestinal disorders
GI disorders - Other, specify - tenesmus
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Gastrointestinal disorders
Hemorrhoids
|
3.4%
1/29 • Up to 2 years
|
10.3%
3/29 • Up to 2 years
|
|
Gastrointestinal disorders
Mucositis oral
|
24.1%
7/29 • Up to 2 years
|
10.3%
3/29 • Up to 2 years
|
|
Gastrointestinal disorders
Nausea
|
55.2%
16/29 • Up to 2 years
|
34.5%
10/29 • Up to 2 years
|
|
Gastrointestinal disorders
Oral hemorrhage
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/29 • Up to 2 years
|
6.9%
2/29 • Up to 2 years
|
|
Gastrointestinal disorders
Rectal pain
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/29 • Up to 2 years
|
10.3%
3/29 • Up to 2 years
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Gastrointestinal disorders
Vomiting
|
24.1%
7/29 • Up to 2 years
|
20.7%
6/29 • Up to 2 years
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other - liver cirrhosis
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Immune system disorders
Allergic reaction
|
6.9%
2/29 • Up to 2 years
|
6.9%
2/29 • Up to 2 years
|
|
Infections and infestations
Appendicitis
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Infections and infestations
Bacteremia
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Infections and infestations
Catheter related infection
|
3.4%
1/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Infections and infestations
Infections & infestations - Other - bladder
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Infections and infestations
Infections & infestations - Other - C.difficile infection
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Infections and infestations
Infections & infestations - Other - COVID-19
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Infections and infestations
Infections & infestations - Other - COVID-19 infection
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Infections and infestations
Infections & infestations - Other - COVID19 infection
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Infections and infestations
Infections & infestations - Other - osteomyelitis
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Infections and infestations
Infections & infestations - Other - Sepsis
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Infections and infestations
Infections & infestations - Other - Whooping cough (pertussis)
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Infections and infestations
Lung infection
|
10.3%
3/29 • Up to 2 years
|
13.8%
4/29 • Up to 2 years
|
|
Infections and infestations
Pharyngitis
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Infections and infestations
Sepsis
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Infections and infestations
Skin infection
|
0.00%
0/29 • Up to 2 years
|
10.3%
3/29 • Up to 2 years
|
|
Infections and infestations
Small intestine infection
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Infections and infestations
Tooth infection
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/29 • Up to 2 years
|
10.3%
3/29 • Up to 2 years
|
|
Infections and infestations
Urinary tract infection
|
6.9%
2/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Infections and infestations
Wound infection
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Injury, poisoning and procedural complications
Bruising
|
17.2%
5/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Injury, poisoning and procedural complications
Fall
|
20.7%
6/29 • Up to 2 years
|
6.9%
2/29 • Up to 2 years
|
|
Injury, poisoning and procedural complications
Fracture
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
3.4%
1/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Injury, poisoning and procedural complications
Injury/poison/procedure - Other - abrasion of bilateral knees
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Injury, poisoning and procedural complications
Injury/poison/procedure - Other - abrasion of left elbow
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Injury, poisoning and procedural complications
Injury/poison/procedure - Other - abrasion to left eye
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Injury, poisoning and procedural complications
Injury/poison/procedure - Other - abrasion to left knee
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Injury, poisoning and procedural complications
Injury/poison/procedure - Other - laceration of left forehead
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Injury, poisoning and procedural complications
Injury/poison/procedure - Other - left hip injury
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Injury, poisoning and procedural complications
Injury/poison/procedure - Other - pain at r. hohn
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Injury, poisoning and procedural complications
Injury/poison/procedure - Other - r. ankle sprain
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Injury, poisoning and procedural complications
Injury/poison/procedure - Other - skin tear
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Injury, poisoning and procedural complications
Injury/poison/procedure - Other - to left wrist
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Injury, poisoning and procedural complications
Injury/poison/procedure - Other - VAD site bleeding
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
3.4%
1/29 • Up to 2 years
|
13.8%
4/29 • Up to 2 years
|
|
Injury, poisoning and procedural complications
Wound complication
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Investigations
Activated PTT prolonged
|
3.4%
1/29 • Up to 2 years
|
6.9%
2/29 • Up to 2 years
|
|
Investigations
Alkaline phosphatase increased
|
17.2%
5/29 • Up to 2 years
|
27.6%
8/29 • Up to 2 years
|
|
Investigations
ALT increased
|
13.8%
4/29 • Up to 2 years
|
31.0%
9/29 • Up to 2 years
|
|
Investigations
AST increased
|
17.2%
5/29 • Up to 2 years
|
34.5%
10/29 • Up to 2 years
|
|
Investigations
Blood bicarbonate decreased
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Investigations
Blood bilirubin increased
|
37.9%
11/29 • Up to 2 years
|
27.6%
8/29 • Up to 2 years
|
|
Investigations
Cardiac troponin I increased
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Investigations
Cardiac troponin T increased
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Investigations
Creatinine increased
|
20.7%
6/29 • Up to 2 years
|
31.0%
9/29 • Up to 2 years
|
|
Investigations
EKG QT corrected interval prolong
|
6.9%
2/29 • Up to 2 years
|
6.9%
2/29 • Up to 2 years
|
|
Investigations
Elevated LDH
|
6.9%
2/29 • Up to 2 years
|
13.8%
4/29 • Up to 2 years
|
|
Investigations
Elevated TSH
|
0.00%
0/29 • Up to 2 years
|
6.9%
2/29 • Up to 2 years
|
|
Investigations
Fibrinogen decreased
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Investigations
INR increased
|
13.8%
4/29 • Up to 2 years
|
27.6%
8/29 • Up to 2 years
|
|
Investigations
Investigations - Other, specify - CRP increased
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Investigations
Investigations - Other, specify - D-Dimer, Quantified Increased
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Investigations
Investigations - Other, specify - Fibrinogen increased
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Investigations
Investigations - Other, specify - Monocyte count decreased
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Investigations
Investigations - Other, specify - vitamin d deficiency
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Investigations
Investigations - Other, specify - WBC increased
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Investigations
Lymphocyte count decreased
|
62.1%
18/29 • Up to 2 years
|
72.4%
21/29 • Up to 2 years
|
|
Investigations
Neutrophil count decreased
|
69.0%
20/29 • Up to 2 years
|
72.4%
21/29 • Up to 2 years
|
|
Investigations
Platelet count decreased
|
69.0%
20/29 • Up to 2 years
|
82.8%
24/29 • Up to 2 years
|
|
Investigations
Weight loss
|
6.9%
2/29 • Up to 2 years
|
20.7%
6/29 • Up to 2 years
|
|
Investigations
White blood cell decreased
|
86.2%
25/29 • Up to 2 years
|
82.8%
24/29 • Up to 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
24.1%
7/29 • Up to 2 years
|
34.5%
10/29 • Up to 2 years
|
|
Metabolism and nutrition disorders
Dehydration
|
3.4%
1/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
3.4%
1/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
31.0%
9/29 • Up to 2 years
|
37.9%
11/29 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
3.4%
1/29 • Up to 2 years
|
6.9%
2/29 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypernatremia
|
3.4%
1/29 • Up to 2 years
|
10.3%
3/29 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
10.3%
3/29 • Up to 2 years
|
20.7%
6/29 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.00%
0/29 • Up to 2 years
|
6.9%
2/29 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
6.9%
2/29 • Up to 2 years
|
6.9%
2/29 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
37.9%
11/29 • Up to 2 years
|
55.2%
16/29 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
34.5%
10/29 • Up to 2 years
|
41.4%
12/29 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
31.0%
9/29 • Up to 2 years
|
55.2%
16/29 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
3.4%
1/29 • Up to 2 years
|
17.2%
5/29 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
31.0%
9/29 • Up to 2 years
|
20.7%
6/29 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
24.1%
7/29 • Up to 2 years
|
27.6%
8/29 • Up to 2 years
|
|
Metabolism and nutrition disorders
Metabolism and nutrition - Other - Failure to thrive
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Metabolism and nutrition disorders
Metabolism and nutrition - Other - Uric acid decreased
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Metabolism and nutrition disorders
Metabolism and nutrition - Other - Vitamin D Deficiency
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Metabolism and nutrition disorders
Obesity
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.4%
1/29 • Up to 2 years
|
13.8%
4/29 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
13.8%
4/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
17.2%
5/29 • Up to 2 years
|
6.9%
2/29 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.9%
2/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
0.00%
0/29 • Up to 2 years
|
6.9%
2/29 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
6.9%
2/29 • Up to 2 years
|
6.9%
2/29 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
10.3%
3/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskel/connect tissue -Other - Bilateral Leg Pain
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskel/connect tissue -Other - degenerative disc disease
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskel/connect tissue -Other - gout flare up
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskel/connect tissue -Other - groin pain
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskel/connect tissue -Other - hip soreness in the mornings and when standing
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskel/connect tissue -Other - Iliac bone sclerosis
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskel/connect tissue -Other - Knee effusion (hemarthrosis)
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskel/connect tissue -Other - Knee effusion (recurrent)
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskel/connect tissue -Other - disease of cervical and lumbar spine
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskel/connect tissue -Other - pain at bone marrow biopsy site
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskel/connect tissue -Other - sclerotic lesions
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskel/connect tissue -Other - Spinal Stenosis
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskel/connect tissue -Other - subcutaneous soft mass r upper quadrant
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.4%
1/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
10.3%
3/29 • Up to 2 years
|
13.8%
4/29 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
20.7%
6/29 • Up to 2 years
|
20.7%
6/29 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff injury
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms - Other - Bakers Cyst
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms - Other - breast mass
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms - Other - complex baker's cyst - Right knee
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms - Other - peripheral blasts
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms - Other - Precancerous skin lesion
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms - Other - thyroid nodule
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Nervous system disorders
Amnesia
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Nervous system disorders
Cognitive disturbance
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Nervous system disorders
Concentration impairment
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Nervous system disorders
Dizziness
|
17.2%
5/29 • Up to 2 years
|
20.7%
6/29 • Up to 2 years
|
|
Nervous system disorders
Dysgeusia
|
3.4%
1/29 • Up to 2 years
|
20.7%
6/29 • Up to 2 years
|
|
Nervous system disorders
Headache
|
17.2%
5/29 • Up to 2 years
|
20.7%
6/29 • Up to 2 years
|
|
Nervous system disorders
Lethargy
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/29 • Up to 2 years
|
6.9%
2/29 • Up to 2 years
|
|
Nervous system disorders
Nervous system - Other - benzodiazapine withdrawal
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Nervous system disorders
Neuralgia
|
6.9%
2/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Nervous system disorders
Paresthesia
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Nervous system disorders
Peripheral motor neuropathy
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Nervous system disorders
Presyncope
|
6.9%
2/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Nervous system disorders
Somnolence
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Nervous system disorders
Tremor
|
6.9%
2/29 • Up to 2 years
|
10.3%
3/29 • Up to 2 years
|
|
Psychiatric disorders
Agitation
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Psychiatric disorders
Anxiety
|
10.3%
3/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Psychiatric disorders
Confusion
|
0.00%
0/29 • Up to 2 years
|
10.3%
3/29 • Up to 2 years
|
|
Psychiatric disorders
Delirium
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Psychiatric disorders
Depression
|
3.4%
1/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Psychiatric disorders
Hallucinations
|
3.4%
1/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Psychiatric disorders
Insomnia
|
20.7%
6/29 • Up to 2 years
|
10.3%
3/29 • Up to 2 years
|
|
Psychiatric disorders
Psychiatric disorders - Other - parasomnia, night terror
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Renal and urinary disorders
Bladder spasm
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Renal and urinary disorders
Chronic kidney disease
|
3.4%
1/29 • Up to 2 years
|
13.8%
4/29 • Up to 2 years
|
|
Renal and urinary disorders
Dysuria
|
13.8%
4/29 • Up to 2 years
|
6.9%
2/29 • Up to 2 years
|
|
Renal and urinary disorders
Glucosuria
|
6.9%
2/29 • Up to 2 years
|
6.9%
2/29 • Up to 2 years
|
|
Renal and urinary disorders
Hematuria
|
10.3%
3/29 • Up to 2 years
|
20.7%
6/29 • Up to 2 years
|
|
Renal and urinary disorders
Proteinuria
|
3.4%
1/29 • Up to 2 years
|
13.8%
4/29 • Up to 2 years
|
|
Renal and urinary disorders
Renal & urinary disorders - Other - eGFR decreased
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Renal and urinary disorders
Renal calculi
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Renal and urinary disorders
Urinary frequency
|
6.9%
2/29 • Up to 2 years
|
13.8%
4/29 • Up to 2 years
|
|
Renal and urinary disorders
Urinary incontinence
|
3.4%
1/29 • Up to 2 years
|
6.9%
2/29 • Up to 2 years
|
|
Renal and urinary disorders
Urinary retention
|
3.4%
1/29 • Up to 2 years
|
10.3%
3/29 • Up to 2 years
|
|
Renal and urinary disorders
Urinary tract obstruction
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Renal and urinary disorders
Urinary urgency
|
6.9%
2/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Renal and urinary disorders
Urine discoloration
|
3.4%
1/29 • Up to 2 years
|
10.3%
3/29 • Up to 2 years
|
|
Reproductive system and breast disorders
Genital edema
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Reproductive system and breast disorders
Testicular disorder
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
34.5%
10/29 • Up to 2 years
|
17.2%
5/29 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
31.0%
9/29 • Up to 2 years
|
27.6%
8/29 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
10.3%
3/29 • Up to 2 years
|
10.3%
3/29 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
6.9%
2/29 • Up to 2 years
|
6.9%
2/29 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/29 • Up to 2 years
|
13.8%
4/29 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.9%
2/29 • Up to 2 years
|
6.9%
2/29 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
3.4%
1/29 • Up to 2 years
|
6.9%
2/29 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.00%
0/29 • Up to 2 years
|
10.3%
3/29 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/29 • Up to 2 years
|
6.9%
2/29 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic & mediast - Other - hypoxia
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic & mediast - Other - incidental lung nodules
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic & mediast - Other - Pulmonary nodule
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
3.4%
1/29 • Up to 2 years
|
10.3%
3/29 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
6.9%
2/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.9%
2/29 • Up to 2 years
|
17.2%
5/29 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.4%
1/29 • Up to 2 years
|
6.9%
2/29 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
3.4%
1/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.3%
3/29 • Up to 2 years
|
17.2%
5/29 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Purpura
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/29 • Up to 2 years
|
6.9%
2/29 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
20.7%
6/29 • Up to 2 years
|
20.7%
6/29 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin & subcutaneous tissue -Other - erythema at CVC of r. jugular
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin & subcutaneous tissue -Other - Erythematous Petechial Rash
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin & subcutaneous tissue -Other - petechia
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin & subcutaneous tissue -Other - petechial non-pruritic rash of bilateral feet
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin & subcutaneous tissue -Other - r. femoral hernia
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin & subcutaneous tissue -Other - rash of back
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin & subcutaneous tissue -Other - rash of neck NOS
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin & subcutaneous tissue -Other - rash of r. ankle NOS
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin & subcutaneous tissue -Other - redness and draining at PICC site
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin & subcutaneous tissue -Other - Scattered petechiae
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin & subcutaneous tissue -Other - skin abrasion ( r. Knee)
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin & subcutaneous tissue -Other - sunburn of nose
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin & subcutaneous tissue -Other - Sweet Syndrome
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin & subcutaneous tissue -Other - Sweet's syndrome
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin & subcutaneous tissue -Other - wound to l. buttock NOS
|
3.4%
1/29 • Up to 2 years
|
0.00%
0/29 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Surgical and medical procedures
Surgical and medical - Other - PICC placement
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Vascular disorders
Hematoma
|
6.9%
2/29 • Up to 2 years
|
10.3%
3/29 • Up to 2 years
|
|
Vascular disorders
Hot flashes
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Vascular disorders
Hypertension
|
13.8%
4/29 • Up to 2 years
|
17.2%
5/29 • Up to 2 years
|
|
Vascular disorders
Hypotension
|
27.6%
8/29 • Up to 2 years
|
27.6%
8/29 • Up to 2 years
|
|
Vascular disorders
Thromboembolic event
|
10.3%
3/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
|
Vascular disorders
Vascular disorders - Other - orthostatic hypotension
|
0.00%
0/29 • Up to 2 years
|
3.4%
1/29 • Up to 2 years
|
Additional Information
Amer Zeidan, MBBS Professor of Internal Medicine (Hematology)
Yale School of Medicine
Phone: (203) 200-4363
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60