Trial Outcomes & Findings for Biomarkers in Predicting Treatment Response to Sirolimus and Chemotherapy in Patients With High-Risk Acute Myeloid Leukemia (NCT NCT02583893)
NCT ID: NCT02583893
Last Updated: 2026-05-29
Results Overview
Defined by change in phosphorylated ribosomal protein S6 (pS6) positive blasts, measured as the % reduction in pS6 positive blasts from baseline to day 4. Biochemical response will be described by mean, median, standard deviation, range and coefficient of variation. The association between biochemical response and clinical response will be tested by Fisher's exact test.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
39 participants
Primary outcome timeframe
Baseline to day 4
Results posted on
2026-05-29
Participant Flow
Participant milestones
| Measure |
Sirolimus, MEC Chemotherapy
Patients undergo collection of bone marrow samples prior to sirolimus dosing on day 4 and within 1 week and no later than day 45 of hematologic recovery. Patients receive sirolimus PO on days 2-9 (loading dose on day 1 only), and standard MEC chemotherapy comprising mitoxantrone hydrochloride IV over 15 minutes, etoposide IV over 1 hour, and cytarabine IV over 1 hour every 24 hours on day 4-8.
Sirolimus: Given PO
Mitoxantrone: Given IV
Etoposide: Given IV
Cytarabine: Given IV
|
|---|---|
|
Overall Study
STARTED
|
39
|
|
Overall Study
COMPLETED
|
36
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Sirolimus, MEC Chemotherapy
Patients undergo collection of bone marrow samples prior to sirolimus dosing on day 4 and within 1 week and no later than day 45 of hematologic recovery. Patients receive sirolimus PO on days 2-9 (loading dose on day 1 only), and standard MEC chemotherapy comprising mitoxantrone hydrochloride IV over 15 minutes, etoposide IV over 1 hour, and cytarabine IV over 1 hour every 24 hours on day 4-8.
Sirolimus: Given PO
Mitoxantrone: Given IV
Etoposide: Given IV
Cytarabine: Given IV
|
|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
Baseline Characteristics
Biomarkers in Predicting Treatment Response to Sirolimus and Chemotherapy in Patients With High-Risk Acute Myeloid Leukemia
Baseline characteristics by cohort
| Measure |
Sirolimus, MEC Chemotherapy
n=39 Participants
Patients undergo collection of bone marrow samples prior to sirolimus dosing on day 4 and within 1 week and no later than day 45 of hematologic recovery. Patients receive sirolimus PO on days 2-9 (loading dose on day 1 only), and standard MEC chemotherapy comprising mitoxantrone hydrochloride IV over 15 minutes, etoposide IV over 1 hour, and cytarabine IV over 1 hour every 24 hours on day 4-8.
Sirolimus: Given PO
Mitoxantrone: Given IV
Etoposide: Given IV
Cytarabine: Given IV
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=51 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
31 Participants
n=51 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=51 Participants
|
|
Age, Continuous
|
59 years
n=51 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=51 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=51 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=51 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
36 Participants
n=51 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=51 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=51 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=51 Participants
|
PRIMARY outcome
Timeframe: Baseline to day 4Population: The outcome cannot be reported because the biochemical data required for this analysis were never collected. As the necessary data were not available, no participants could be analyzed, and the outcome measure could not be accurately reported. No attempts will be made in the future to procure the data as the data needed was never collected.
Defined by change in phosphorylated ribosomal protein S6 (pS6) positive blasts, measured as the % reduction in pS6 positive blasts from baseline to day 4. Biochemical response will be described by mean, median, standard deviation, range and coefficient of variation. The association between biochemical response and clinical response will be tested by Fisher's exact test.
Outcome measures
| Measure |
Sirolimus, MEC Chemotherapy
Patients undergo collection of bone marrow samples prior to sirolimus dosing on day 4 and within 1 week and no later than day 45 of hematologic recovery. Patients receive sirolimus PO on days 2-9 (loading dose on day 1 only), and standard MEC chemotherapy comprising mitoxantrone hydrochloride IV over 15 minutes, etoposide IV over 1 hour, and cytarabine IV over 1 hour every 24 hours on day 4-8.
Sirolimus: Given PO
Mitoxantrone: Given IV
Etoposide: Given IV
Cytarabine: Given IV
|
|---|---|
|
Biochemical Response
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 45Population: 3 patients were unable to be assessed for response due to either removal from trial or lost to follow up
Clinical response was assessed at Day 45 using IWG criteria: Complete Remission (CR), CR with incomplete platelet recovery (CRp), CR with incomplete hematologic recovery (CRi), Partial Remission (PR), or No Response (NR). CR requires normalized blood counts and bone marrow blasts \<5%. CRp meets CR except platelet recovery; CRi meets CR except incomplete neutrophil/platelet recovery. PR is ≥50% reduction in marrow blasts to 5-25% with partial blood count improvement. NR indicates failure to meet these criteria. Tumor response per RECIST v1.0: CR = disappearance of all target lesions; PR = ≥30% decrease in sum of longest diameters; Overall Response = CR + PR. Progression = ≥20% increase in sum of longest diameters, measurable increase in non-target lesion, or new lesions.
Outcome measures
| Measure |
Sirolimus, MEC Chemotherapy
n=36 Participants
Patients undergo collection of bone marrow samples prior to sirolimus dosing on day 4 and within 1 week and no later than day 45 of hematologic recovery. Patients receive sirolimus PO on days 2-9 (loading dose on day 1 only), and standard MEC chemotherapy comprising mitoxantrone hydrochloride IV over 15 minutes, etoposide IV over 1 hour, and cytarabine IV over 1 hour every 24 hours on day 4-8.
Sirolimus: Given PO
Mitoxantrone: Given IV
Etoposide: Given IV
Cytarabine: Given IV
|
|---|---|
|
Clinical Response
Disease Progression
|
20 Participants
|
|
Clinical Response
Favorable Response
|
15 Participants
|
SECONDARY outcome
Timeframe: Day 45Fraction of patients who achieve CR, CRp, or PR will be assessed. ORR and 95% exact confidence interval will be computed for all patients and for sensitive and resistant subgroups.
Outcome measures
| Measure |
Sirolimus, MEC Chemotherapy
n=36 Participants
Patients undergo collection of bone marrow samples prior to sirolimus dosing on day 4 and within 1 week and no later than day 45 of hematologic recovery. Patients receive sirolimus PO on days 2-9 (loading dose on day 1 only), and standard MEC chemotherapy comprising mitoxantrone hydrochloride IV over 15 minutes, etoposide IV over 1 hour, and cytarabine IV over 1 hour every 24 hours on day 4-8.
Sirolimus: Given PO
Mitoxantrone: Given IV
Etoposide: Given IV
Cytarabine: Given IV
|
|---|---|
|
Overall Response Rate (ORR) (Complete Response [CR], CR With Incomplete Platelet Recovery [CRp], or Partial Response)
Complete response [CR]
|
7 Participants
|
|
Overall Response Rate (ORR) (Complete Response [CR], CR With Incomplete Platelet Recovery [CRp], or Partial Response)
CR with incomplete platelet recovery [CRp]
|
4 Participants
|
|
Overall Response Rate (ORR) (Complete Response [CR], CR With Incomplete Platelet Recovery [CRp], or Partial Response)
Partial response
|
2 Participants
|
SECONDARY outcome
Timeframe: Time from study entry to first documented progression, death, or last contact, assessed up to 2 yearsPopulation: A total of 36 participants were evaluable for relapse free survival.
RFS will be estimated by the Kaplan-Meier method. A landmark analysis of RFS by clinical response (CR+CRp, CRi, PR or no response \[NR\]) will be computed from day 45 marrow assessment. Median values and 95% confidence intervals will be calculated.
Outcome measures
| Measure |
Sirolimus, MEC Chemotherapy
n=39 Participants
Patients undergo collection of bone marrow samples prior to sirolimus dosing on day 4 and within 1 week and no later than day 45 of hematologic recovery. Patients receive sirolimus PO on days 2-9 (loading dose on day 1 only), and standard MEC chemotherapy comprising mitoxantrone hydrochloride IV over 15 minutes, etoposide IV over 1 hour, and cytarabine IV over 1 hour every 24 hours on day 4-8.
Sirolimus: Given PO
Mitoxantrone: Given IV
Etoposide: Given IV
Cytarabine: Given IV
|
|---|---|
|
Relapse Free Survival (RFS)
|
8 Participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsOverall Survival (OS) is defined as the time from study entry to death or last contact. OS will be analyzed by risk groups: Favorable, Intermediate, and Poor/Adverse, based on baseline factors such as cytogenetics, molecular markers, and clinical characteristics. These risk groups are used to predict clinical outcomes, with favorable indicating longer survival expectancy, intermediate suggesting moderate outcomes, and poor/adverse indicating more aggressive disease with lower survival rates. Results will be reported as the percentage of participants in each risk category.
Outcome measures
| Measure |
Sirolimus, MEC Chemotherapy
n=36 Participants
Patients undergo collection of bone marrow samples prior to sirolimus dosing on day 4 and within 1 week and no later than day 45 of hematologic recovery. Patients receive sirolimus PO on days 2-9 (loading dose on day 1 only), and standard MEC chemotherapy comprising mitoxantrone hydrochloride IV over 15 minutes, etoposide IV over 1 hour, and cytarabine IV over 1 hour every 24 hours on day 4-8.
Sirolimus: Given PO
Mitoxantrone: Given IV
Etoposide: Given IV
Cytarabine: Given IV
|
|---|---|
|
Percentage of Participants by Risk Group
Intermediate
|
40 percentage of participants
|
|
Percentage of Participants by Risk Group
Poor/Adverse
|
15 percentage of participants
|
|
Percentage of Participants by Risk Group
Favorable
|
45 percentage of participants
|
Adverse Events
Sirolimus, MEC Chemotherapy
Serious events: 5 serious events
Other events: 27 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Sirolimus, MEC Chemotherapy
n=39 participants at risk
Patients undergo collection of bone marrow samples prior to sirolimus dosing on day 4 and within 1 week and no later than day 45 of hematologic recovery. Patients receive sirolimus PO on days 2-9 (loading dose on day 1 only), and standard MEC chemotherapy comprising mitoxantrone hydrochloride IV over 15 minutes, etoposide IV over 1 hour, and cytarabine IV over 1 hour every 24 hours on day 4-8.
Sirolimus: Given PO
Mitoxantrone: Given IV
Etoposide: Given IV
Cytarabine: Given IV
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia - Grade 3
|
12.8%
5/39 • Number of events 6 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Blood and lymphatic system disorders
E. coli Bacteremia - Grade 3
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Metabolism and nutrition disorders
Hypophosphatemia - Grade 4
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Infections and infestations
Infections and infestations- other (MRSA bacteremia) - Grade 3
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Infections and infestations
Lung infection - Grade 3
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Gastrointestinal disorders
Mucositis oral - Grade 3
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant, and unspecified- other (Expired due to AML) - Grade 5
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
General disorders
Non-cardiac chest pain - Grade 1
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Infections and infestations
Sepsis - Grade 4
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Infections and infestations
Skin infection - Grade 3
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Surgical and medical procedures
Left lat. abdom. pain, stent migration into stomach w/ total obstruc. & disten., Left flank pain- G3
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Nervous system disorders
Syncope - Grade 3
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
Other adverse events
| Measure |
Sirolimus, MEC Chemotherapy
n=39 participants at risk
Patients undergo collection of bone marrow samples prior to sirolimus dosing on day 4 and within 1 week and no later than day 45 of hematologic recovery. Patients receive sirolimus PO on days 2-9 (loading dose on day 1 only), and standard MEC chemotherapy comprising mitoxantrone hydrochloride IV over 15 minutes, etoposide IV over 1 hour, and cytarabine IV over 1 hour every 24 hours on day 4-8.
Sirolimus: Given PO
Mitoxantrone: Given IV
Etoposide: Given IV
Cytarabine: Given IV
|
|---|---|
|
Skin and subcutaneous tissue disorders
Rash maculopapular - Grade 2
|
5.1%
2/39 • Number of events 2 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Gastrointestinal disorders
Rectal pain - Grade 1
|
5.1%
2/39 • Number of events 2 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Renal and urinary disorders
Renal and urinary disorders- other (Polyuria) - Grade 1
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Metabolism and nutrition disorders
Anorexia - Grade 1
|
25.6%
10/39 • Number of events 10 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Metabolism and nutrition disorders
Anorexia - Grade 2
|
12.8%
5/39 • Number of events 5 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Metabolism and nutrition disorders
Anorexia - Grade 3
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Psychiatric disorders
Anxiety - Grade 1
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Infections and infestations
Appendicitis - Grade 3
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Musculoskeletal and connective tissue disorders
Arthralgia - Grade 1
|
10.3%
4/39 • Number of events 4 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Musculoskeletal and connective tissue disorders
Arthralgia - Grade 2
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Musculoskeletal and connective tissue disorders
Arthralgia - Grade 3
|
5.1%
2/39 • Number of events 2 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Investigations
AST increased - Grade 1
|
28.2%
11/39 • Number of events 13 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Investigations
AST increased - Grade 2
|
10.3%
4/39 • Number of events 4 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Cardiac disorders
Atrial Fibrillation - Grade 3
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Musculoskeletal and connective tissue disorders
Back pain - Grade 1
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Investigations
Blood bilirubin increased - Grade 1
|
17.9%
7/39 • Number of events 12 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Investigations
Blood bilirubin increased - Grade 2
|
10.3%
4/39 • Number of events 5 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Investigations
Blood bilirubin increased - Grade 3
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Eye disorders
Blurred vision - Grade 2
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Renal and urinary disorders
Urinary frequency - Grade 1
|
20.5%
8/39 • Number of events 8 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Musculoskeletal and connective tissue disorders
Bone pain - Grade 1
|
7.7%
3/39 • Number of events 3 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Musculoskeletal and connective tissue disorders
Bone pain - Grade 2
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Injury, poisoning and procedural complications
Bruising - Grade 1
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Cardiac disorders
Cardiac disorders- other (systolic murmur) - Grade 1
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Cardiac disorders
Catheter related infection - Grade 2
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Cardiac disorders
Catheter related infection - Grade 3
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
General disorders
Chills - Grade 1
|
5.1%
2/39 • Number of events 2 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Hepatobiliary disorders
Cholecystitis - Grade 2
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Gastrointestinal disorders
Colitis - Grade 2
|
5.1%
2/39 • Number of events 2 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Gastrointestinal disorders
Colitis - Grade 3
|
5.1%
2/39 • Number of events 2 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Gastrointestinal disorders
Colonic obstruction - Grade 2
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Psychiatric disorders
Confusion - Grade 1
|
10.3%
4/39 • Number of events 4 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Psychiatric disorders
Confusion - Grade 2
|
5.1%
2/39 • Number of events 2 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Gastrointestinal disorders
Constipation - Grade 1
|
23.1%
9/39 • Number of events 12 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Gastrointestinal disorders
Constipation - Grade 2
|
12.8%
5/39 • Number of events 5 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Respiratory, thoracic and mediastinal disorders
Cough - Grade 1
|
15.4%
6/39 • Number of events 7 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Investigations
Creatinine increased - Grade 1
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
General disorders
Death- NOS (progressive disease) - Grade 5
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Metabolism and nutrition disorders
Dehydration - Grade 1
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Psychiatric disorders
Depressed mood - Grade 1
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Psychiatric disorders
Depression - Grade 1
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Gastrointestinal disorders
Diarrhea - Grade 1
|
56.4%
22/39 • Number of events 26 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Gastrointestinal disorders
Diarrhea - Grade 2
|
5.1%
2/39 • Number of events 2 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Gastrointestinal disorders
Diarrhea - Grade 3
|
5.1%
2/39 • Number of events 2 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Nervous system disorders
Dizziness - Grade 1
|
17.9%
7/39 • Number of events 8 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Eye disorders
Dry eyes - Grade 1
|
7.7%
3/39 • Number of events 3 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Gastrointestinal disorders
Dry mouth - Grade 1
|
12.8%
5/39 • Number of events 5 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Gastrointestinal disorders
Dry mouth - Grade 2
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Skin and subcutaneous tissue disorders
Dry skin - Grade 1
|
5.1%
2/39 • Number of events 2 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Nervous system disorders
Dysgeusia - Grade 1
|
10.3%
4/39 • Number of events 4 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Nervous system disorders
Dysgeusia - Grade 2
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Gastrointestinal disorders
Dyspepsia - Grade 1
|
10.3%
4/39 • Number of events 4 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Gastrointestinal disorders
Dyspepsia - Grade 2
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Gastrointestinal disorders
Dysphagia - Grade 2
|
5.1%
2/39 • Number of events 3 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea - Grade 1
|
15.4%
6/39 • Number of events 6 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders- other (Increased ear wax) - Grade 1
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders- other (fluid in left ear) - Grade 1
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Ear and labyrinth disorders
Ear pain - Grade 1
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
General disorders
Edema- face - Grade 1
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
General disorders
Edema- face - Grade 2
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
General disorders
Edema- limb - Grade 1
|
25.6%
10/39 • Number of events 11 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
General disorders
Edema- limb - Grade 2
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Infections and infestations
Enterocolitis infectious - Grade 2
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Infections and infestations
Enterocolitis infectious - Grade 3
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis - Grade 1
|
28.2%
11/39 • Number of events 11 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis - Grade 2
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Gastrointestinal disorders
Esophagitis - Grade 2
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Eye disorders
Eye disorders- other (Conjunctival hemorrhage in nasal corner of eyes B/L) - Grade 1
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Eye disorders
Eye disorders- other (Pupils unequal) - Grade 1
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Injury, poisoning and procedural complications
Fall - Grade 3
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
General disorders
Fatigue - Grade 1
|
30.8%
12/39 • Number of events 13 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
General disorders
Fatigue - Grade 2
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Blood and lymphatic system disorders
Febrile Neutropenia - Grade 3
|
69.2%
27/39 • Number of events 29 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Gastrointestinal disorders
Fecal incontinence - Grade 1
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Gastrointestinal disorders
Fecal incontinence - Grade 2
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
General disorders
Fever - Grade 1
|
10.3%
4/39 • Number of events 4 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Investigations
Fibrinogen decreased - Grade 1
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Gastrointestinal disorders
Flatulence - Grade 1
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Injury, poisoning and procedural complications
Fracture - Grade 2
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease - Grade 1
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Gastrointestinal disorders
Gastrointestinal disorders- other (Melena) - Grade 1
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Gastrointestinal disorders
Gastrointestinal disorders- other (Nasal dryness) - Grade 1
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Gastrointestinal disorders
Gastrointestinal disorders- other (Mouth sores, cut from dentures) - Grade 1
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Gastrointestinal disorders
Gastrointestinal disorders- other (Gut GVHD) - Grade 3
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Gastrointestinal disorders
Gastrointestinal disorders- other (Sore throat with thrush on tongue) - Grade 1
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Renal and urinary disorders
Urinary incontinence - Grade 1
|
7.7%
3/39 • Number of events 3 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Gastrointestinal disorders
Gastrointestinal disorders- other (Thrush) - Grade 1
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Gastrointestinal disorders
Gastrointestinal disorders- other (Oral plaques, white thrush) - Grade 1
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
General disorders
General disorders and administration site conditions- other (Generalized edema) - Grade 1
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
General disorders
General disorders and administration site conditions- other (Feeling hot after starting MEC) - Gr. 1
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
General disorders
General disorders and administration site conditions- other (Volume overload) - Grade 1
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
General disorders
General disorders and administration site conditions- other (Hypervolemia) - Grade 1
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness - Grade 1
|
25.6%
10/39 • Number of events 10 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness - Grade 2
|
5.1%
2/39 • Number of events 2 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Psychiatric disorders
Hallucinations - Grade 1
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Nervous system disorders
Headache - Grade 1
|
38.5%
15/39 • Number of events 17 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Nervous system disorders
Headache - Grade 2
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Nervous system disorders
Headache - Grade 3
|
5.1%
2/39 • Number of events 2 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Ear and labyrinth disorders
Hearing impaired - Grade 1
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Cardiac disorders
Heart failure - Grade 3
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Vascular disorders
Hematoma - Grade 1
|
5.1%
2/39 • Number of events 2 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Renal and urinary disorders
Hematuria - Grade 1
|
15.4%
6/39 • Number of events 6 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Renal and urinary disorders
Hematuria - Grade 3
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Gastrointestinal disorders
Hemorrhoids - Grade 1
|
15.4%
6/39 • Number of events 6 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups - Grade 1
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups - Grade 2
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Vascular disorders
Hot flashes - Grade 1
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Metabolism and nutrition disorders
Hypercalcemia - Grade 1
|
5.1%
2/39 • Number of events 4 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Metabolism and nutrition disorders
Hyperglycemia - Grade 1
|
28.2%
11/39 • Number of events 17 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Metabolism and nutrition disorders
Hyperglycemia - Grade 2
|
30.8%
12/39 • Number of events 24 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Metabolism and nutrition disorders
Hyperglycemia - Grade 3
|
7.7%
3/39 • Number of events 4 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis - Grade 1
|
10.3%
4/39 • Number of events 4 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Metabolism and nutrition disorders
Hyperkalemia - Grade 1
|
17.9%
7/39 • Number of events 12 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Metabolism and nutrition disorders
Hypermagnesemia - Grade 1
|
10.3%
4/39 • Number of events 4 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Metabolism and nutrition disorders
Hypermagnesemia - Grade 3
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Metabolism and nutrition disorders
Hypernatremia - Grade 1
|
15.4%
6/39 • Number of events 9 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Metabolism and nutrition disorders
Hypernatremia - Grade 2
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Vascular disorders
Hypertension - Grade 2
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Vascular disorders
Hypertension - Grade 3
|
10.3%
4/39 • Number of events 4 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Metabolism and nutrition disorders
Hyperuricemia - Grade 1
|
5.1%
2/39 • Number of events 3 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Metabolism and nutrition disorders
Hypoalbuminemia - Grade 1
|
28.2%
11/39 • Number of events 18 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Metabolism and nutrition disorders
Hypoalbuminemia - Grade 2
|
20.5%
8/39 • Number of events 11 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Metabolism and nutrition disorders
Hypoalbuminemia - Grade 3
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Metabolism and nutrition disorders
Hypocalcemia - Grade 1
|
41.0%
16/39 • Number of events 30 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Metabolism and nutrition disorders
Hypocalcemia - Grade 2
|
12.8%
5/39 • Number of events 13 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Metabolism and nutrition disorders
Hypocalcemia - Grade 3
|
10.3%
4/39 • Number of events 10 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Metabolism and nutrition disorders
Hypocalcemia - Grade 4
|
2.6%
1/39 • Number of events 5 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Metabolism and nutrition disorders
Hypoglycemia - Grade 1
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Metabolism and nutrition disorders
Hypokalemia - Grade 1
|
46.2%
18/39 • Number of events 27 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Metabolism and nutrition disorders
Hypokalemia - Grade 2
|
28.2%
11/39 • Number of events 19 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Metabolism and nutrition disorders
Hypokalemia - Grade 3
|
20.5%
8/39 • Number of events 11 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Metabolism and nutrition disorders
Hypomagnesemia - Grade 1
|
15.4%
6/39 • Number of events 10 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Metabolism and nutrition disorders
Hypomagnesemia - Grade 2
|
7.7%
3/39 • Number of events 4 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Metabolism and nutrition disorders
Hyponatremia - Grade 1
|
17.9%
7/39 • Number of events 8 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Metabolism and nutrition disorders
Hyponatremia - Grade 3
|
2.6%
1/39 • Number of events 3 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Metabolism and nutrition disorders
Hypophosphatemia - Grade 2
|
48.7%
19/39 • Number of events 40 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Metabolism and nutrition disorders
Hypophosphatemia - Grade 3
|
41.0%
16/39 • Number of events 28 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Metabolism and nutrition disorders
Hypophosphatemia - Grade 4
|
2.6%
1/39 • Number of events 4 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Vascular disorders
Hypotension - Grade 1
|
7.7%
3/39 • Number of events 3 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Vascular disorders
Hypotension - Grade 2
|
5.1%
2/39 • Number of events 2 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Infections and infestations
Infections and infestations- other (VRE bacteremia) - Grade 3
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Infections and infestations
Infections and infestations- other (Mild thrush) - Grade 1
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Infections and infestations
Infections and infestations- other (Thrush) - Grade 2
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Infections and infestations
Infections and infestations- other (VRE bacteremia from PICC line) - Grade 3
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Infections and infestations
Infections and infestations- other (Klebsiella, CRE bacteremia) - Grade 3
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Infections and infestations
Infections and infestations- other (Klebsiella bacteremia) - Grade 3
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
General disorders
Infusion related reaction - Grade 1
|
10.3%
4/39 • Number of events 4 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
General disorders
Infusion related reaction - Grade 2
|
5.1%
2/39 • Number of events 2 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Investigations
INR Increased - Grade 1
|
38.5%
15/39 • Number of events 17 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Investigations
INR Increased - Grade 2
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Psychiatric disorders
Insomnia - Grade 1
|
20.5%
8/39 • Number of events 8 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Nervous system disorders
Intracranial hemorrhage - Grade 2
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Musculoskeletal and connective tissue disorders
Joint effusion - Grade 1
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
General disorders
Localized edema - Grade 1
|
5.1%
2/39 • Number of events 2 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Infections and infestations
Lung infection - Grade 3
|
10.3%
4/39 • Number of events 4 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
General disorders
Malaise - Grade 1
|
5.1%
2/39 • Number of events 2 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Reproductive system and breast disorders
Menorrhagia - Grade 2
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Metabolism and nutrition disorders
Metabolism & nutr. disorders- other (Vitamin K deficiency coagulation disorder. INR increased) - Gr1
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders- other (Appetite increased) - Grade 1
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Infections and infestations
Mucosal infection - Grade 1
|
7.7%
3/39 • Number of events 3 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Gastrointestinal disorders
Mucositis oral - Grade 1
|
25.6%
10/39 • Number of events 10 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Gastrointestinal disorders
Mucositis oral - Grade 2
|
23.1%
9/39 • Number of events 9 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Gastrointestinal disorders
Mucositis oral - Grade 3
|
10.3%
4/39 • Number of events 4 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders- other (tightness in lower extremities) - Grade 1
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders- other (tendonitis) - Grade 1
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Musculoskeletal and connective tissue disorders
Myalgia - Grade 1
|
12.8%
5/39 • Number of events 5 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Musculoskeletal and connective tissue disorders
Myalgia - Grade 2
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion - Grade 1
|
12.8%
5/39 • Number of events 5 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Gastrointestinal disorders
Nausea - Grade 1
|
46.2%
18/39 • Number of events 20 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Gastrointestinal disorders
Nausea - Grade 2
|
17.9%
7/39 • Number of events 7 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Musculoskeletal and connective tissue disorders
Neck pain - Grade 1
|
5.1%
2/39 • Number of events 2 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Musculoskeletal and connective tissue disorders
Neck pain - Grade 2
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Nervous system disorders
Neuropathy - Grade 1
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
General disorders
Non-cardiac chest pain - Grade 1
|
5.1%
2/39 • Number of events 2 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Gastrointestinal disorders
Oral pain - Grade 1
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
General disorders
Pain - Grade 1
|
5.1%
2/39 • Number of events 2 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
General disorders
Pain - Grade 2
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity - Grade 1
|
7.7%
3/39 • Number of events 3 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity - Grade 2
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Skin and subcutaneous tissue disorders
Pain of skin - Grade 1
|
5.1%
2/39 • Number of events 2 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Gastrointestinal disorders
Pancreatitis - Grade 2
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Nervous system disorders
Paresthesia - Grade 1
|
5.1%
2/39 • Number of events 2 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Skin and subcutaneous tissue disorders
Periorbital edema - Grade 1
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Eye disorders
Photophobia - Grade 1
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion - Grade 1
|
5.1%
2/39 • Number of events 2 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion - Grade 2
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion - Grade 3
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Renal and urinary disorders
Proteinuria - Grade 1
|
28.2%
11/39 • Number of events 11 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Skin and subcutaneous tissue disorders
Pruritus - Grade 1
|
7.7%
3/39 • Number of events 3 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Skin and subcutaneous tissue disorders
Pruritus - Grade 2
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema - Grade 2
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Skin and subcutaneous tissue disorders
Rash - Grade 1
|
10.3%
4/39 • Number of events 4 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Skin and subcutaneous tissue disorders
Rash - Grade 2
|
7.7%
3/39 • Number of events 4 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Skin and subcutaneous tissue disorders
Rash acneiform - Grade 1
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Skin and subcutaneous tissue disorders
Rash maculopapular - Grade 1
|
33.3%
13/39 • Number of events 16 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Gastrointestinal disorders
abdominal distension - grade 1
|
5.1%
2/39 • Number of events 2 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Gastrointestinal disorders
Abdominal Pain - Grade 1
|
17.9%
7/39 • Number of events 7 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Gastrointestinal disorders
Abdominal Pain - Grade 2
|
5.1%
2/39 • Number of events 2 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Metabolism and nutrition disorders
Acidosis - Grade 1
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
General disorders
Acute infusion reaction - Grade 1
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
General disorders
Acute infusion reaction - Grade 2
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Renal and urinary disorders
Acute kidney injury - Grade 1
|
2.6%
1/39 • Number of events 4 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Renal and urinary disorders
Acute kidney injury - Grade 2
|
2.6%
1/39 • Number of events 2 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Investigations
Alkaline phosphatase increased - Grade 1
|
30.8%
12/39 • Number of events 12 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Investigations
Alkaline phosphatase increased - Grade 2
|
12.8%
5/39 • Number of events 6 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Investigations
Alkaline phosphatase increased - Grade 3
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Metabolism and nutrition disorders
Alkalosis - Grade 3
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Skin and subcutaneous tissue disorders
Alopecia - Grade 1
|
15.4%
6/39 • Number of events 6 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Investigations
ALT increased - Grade 1
|
30.8%
12/39 • Number of events 16 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Investigations
ALT increased - Grade 2
|
10.3%
4/39 • Number of events 5 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Investigations
ALT increased - Grade 3
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Immune system disorders
Anaphylaxis - Grade 3
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Renal and urinary disorders
Renal and urinary disorders- other (Mild bladder pressure) - Grade 1
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure - Grade 4
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic, and mediastinal disorders- other (Hemoptysis) - Grade 1
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Infections and infestations
Sepsis - Grade 4
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Infections and infestations
Sepsis - Grade 5
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Cardiac disorders
Sinus bradycardia - Grade 1
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Nervous system disorders
Sinus pain - Grade 2
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Cardiac disorders
Sinus tachycardia - Grade 1
|
12.8%
5/39 • Number of events 5 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Infections and infestations
Sinusitis - Grade 2
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Infections and infestations
Sinusitis - Grade 3
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous disorders- other (Bruising and bump to lower abdomen) - Grade 1
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous disorders- other (Ingrown toenail) - Grade 1
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous disorders- other (Small bump on leg. Hard) - Grade 1
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous disorders- other (Elevated, circular, darkened area on R FA) - Grade 1
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous disorders- other (Slight erythema on left arm proximal to PICC site) - Grade 1
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous disorders- other (Erythematous rash, skin tear) - Grade 1
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation - Grade 1
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Infections and infestations
Skin infection - Grade 1
|
7.7%
3/39 • Number of events 3 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Infections and infestations
Skin infection - Grade 2
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Gastrointestinal disorders
Small intestinal obstruction - Grade 2
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat - Grade 1
|
15.4%
6/39 • Number of events 6 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Vascular disorders
Thromboembolic event - Grade 1
|
5.1%
2/39 • Number of events 2 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Vascular disorders
Thromboembolic event - Grade 2
|
10.3%
4/39 • Number of events 4 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Gastrointestinal disorders
Toothache - Grade 1
|
5.1%
2/39 • Number of events 2 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Gastrointestinal disorders
Toothache - Grade 2
|
7.7%
3/39 • Number of events 3 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Gastrointestinal disorders
Toothache - Grade 3
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
General disorders
Transfusion related reaction - Grade 2
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Musculoskeletal and connective tissue disorders
Trismus - Grade 1
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome - Grade 3
|
5.1%
2/39 • Number of events 2 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Renal and urinary disorders
Urinary incontinence - Grade 2
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Infections and infestations
Urinary tract infection - Grade 2
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Infections and infestations
Urinary tract infection - Grade 3
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Renal and urinary disorders
Urine discoloration - Grade 1
|
7.7%
3/39 • Number of events 3 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Reproductive system and breast disorders
Vaginal hemorrhage - Grade 1
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Reproductive system and breast disorders
Vaginal inflammation - Grade 1
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Gastrointestinal disorders
Vomiting - Grade 1
|
46.2%
18/39 • Number of events 21 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Gastrointestinal disorders
Vomiting - Grade 2
|
10.3%
4/39 • Number of events 5 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Gastrointestinal disorders
Vomiting - Grade 3
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Investigations
Weight gain - Grade 1
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Investigations
Weight loss - Grade 1
|
5.1%
2/39 • Number of events 2 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing - Grade 1
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
|
Psychiatric disorders
Anxiety - Grade 2
|
2.6%
1/39 • Number of events 1 • Deaths were assessed for up to 2 years. Adverse Events were assessed up to 45 days
CTCAE
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place