Trial Outcomes & Findings for A Study of Granix to Disrupt the Bone Marrow Microenvironment in Patients With Multiple Myeloma Undergoing Autologous Transplantation (NCT NCT02112045)
NCT ID: NCT02112045
Last Updated: 2019-11-26
Results Overview
Complete response (CR) requires all of the following: * Disappearance of monoclonal protein by both protein electrophoresis and immunofixation studies from the blood and urine * \<5% plasma cells in the bone marrow * Disappearance of soft tissue plasmacytomas Stringent complete response (sCR) requires all of the following: * CR as defined above * Normal free light chain ratio * Absence of clonal cells in the bone marrow by immunohistochemistry or immunofluorescence
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
90 participants
Primary outcome timeframe
Day +100
Results posted on
2019-11-26
Participant Flow
The study opened to participant enrollment on 01/20/2015 and closed to participant enrollment on 07/03/2018.
Participant milestones
| Measure |
Experimental: Granix and High Dose Melphalan (HDM)
Granix on Day -7 through Day -2.
HDM intravenously (IV) on Day -2.
Autologous stem cell transplantation on Day 0
|
Control: High Dose Melphalan (HDM)
HDM intravenously (IV) on Day -2.
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
45
|
|
Overall Study
COMPLETED
|
44
|
45
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Experimental: Granix and High Dose Melphalan (HDM)
Granix on Day -7 through Day -2.
HDM intravenously (IV) on Day -2.
Autologous stem cell transplantation on Day 0
|
Control: High Dose Melphalan (HDM)
HDM intravenously (IV) on Day -2.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
A Study of Granix to Disrupt the Bone Marrow Microenvironment in Patients With Multiple Myeloma Undergoing Autologous Transplantation
Baseline characteristics by cohort
| Measure |
Experimental: Granix and High Dose Melphalan (HDM)
n=45 Participants
Granix on Day -7 through Day -2.
HDM intravenously (IV) on Day -2.
Autologous stem cell transplantation on Day 0
|
Control: High Dose Melphalan (HDM)
n=45 Participants
HDM intravenously (IV) on Day -2.
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57 years
n=5 Participants
|
62 years
n=7 Participants
|
59.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
45 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
41 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
45 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day +100Complete response (CR) requires all of the following: * Disappearance of monoclonal protein by both protein electrophoresis and immunofixation studies from the blood and urine * \<5% plasma cells in the bone marrow * Disappearance of soft tissue plasmacytomas Stringent complete response (sCR) requires all of the following: * CR as defined above * Normal free light chain ratio * Absence of clonal cells in the bone marrow by immunohistochemistry or immunofluorescence
Outcome measures
| Measure |
Experimental: Granix and High Dose Melphalan (HDM)
n=44 Participants
Granix on Day -7 through Day -2.
HDM intravenously (IV) on Day -2.
Autologous stem cell transplantation on Day 0
|
Control: High Dose Melphalan (HDM)
n=45 Participants
HDM intravenously (IV) on Day -2.
|
|---|---|---|
|
Number of Participants With Complete Response or Stringent Complete Response
|
17 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: Up through Day 30-Assessed by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Outcome measures
| Measure |
Experimental: Granix and High Dose Melphalan (HDM)
n=45 Participants
Granix on Day -7 through Day -2.
HDM intravenously (IV) on Day -2.
Autologous stem cell transplantation on Day 0
|
Control: High Dose Melphalan (HDM)
n=45 Participants
HDM intravenously (IV) on Day -2.
|
|---|---|---|
|
Number of Participants With Adverse Events
Febrile neutropenia
|
30 Participants
|
27 Participants
|
|
Number of Participants With Adverse Events
Atrial fibrillation
|
3 Participants
|
2 Participants
|
|
Number of Participants With Adverse Events
Left ventricular systolic function
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events
Sinus tachycardia
|
1 Participants
|
3 Participants
|
|
Number of Participants With Adverse Events
Excessive cerumen
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events
Impacted cerumen
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events
Dry eye
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events
Abdominal pain
|
2 Participants
|
2 Participants
|
|
Number of Participants With Adverse Events
Colitis
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events
Colonic perforation
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events
Constipation
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events
Diarrhea
|
5 Participants
|
11 Participants
|
|
Number of Participants With Adverse Events
Enterocolitis
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events
Epigastric pain
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events
Esophagitis
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events
Hemorrhoids
|
0 Participants
|
2 Participants
|
|
Number of Participants With Adverse Events
Ileus
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events
Mucositis oral
|
16 Participants
|
14 Participants
|
|
Number of Participants With Adverse Events
Nausea
|
3 Participants
|
5 Participants
|
|
Number of Participants With Adverse Events
Oral pain
|
1 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events
Upper gastrointestinal hemorrhage
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events
Edema limbs
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events
Fever
|
5 Participants
|
4 Participants
|
|
Number of Participants With Adverse Events
Infusion related reaction
|
1 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events
Malaise
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events
Pain
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events
Allergic reaction
|
1 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events
Bacteremia-Coagulase negative staphyococcus
|
2 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events
Bacteremia - Enterobacter Clocae
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events
Bacteremia - Fusobacterium
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events
Bacteremia - MSSA
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events
Bacteremia - Pseudomonas Aeruginosa
|
3 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events
Bacteremia - Streptococcus mitis
|
1 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events
Candida (groin)
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events
Clostridium difficile
|
3 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events
Lung infection
|
3 Participants
|
3 Participants
|
|
Number of Participants With Adverse Events
Mucosal infection (oral thrush)
|
10 Participants
|
11 Participants
|
|
Number of Participants With Adverse Events
Peri-rectal yeast infection
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events
Sepsis
|
1 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events
Skin infection
|
3 Participants
|
3 Participants
|
|
Number of Participants With Adverse Events
Splenic infection
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events
Upper respiratory infection
|
2 Participants
|
4 Participants
|
|
Number of Participants With Adverse Events
Urinary tract infection
|
0 Participants
|
4 Participants
|
|
Number of Participants With Adverse Events
Vaginal infection
|
1 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events
Bleeding from CVC insertion site
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events
Fall
|
2 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events
Activated partial thromboplastin time prolonged
|
1 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events
Aspartate aminotransferase increased
|
1 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events
Blood bilirubin increased
|
3 Participants
|
2 Participants
|
|
Number of Participants With Adverse Events
Creatinine increased
|
4 Participants
|
3 Participants
|
|
Number of Participants With Adverse Events
Electrocardiogram QT corrected interval prolonged
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events
Weight loss
|
6 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events
Anorexia
|
1 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events
Dehydration
|
6 Participants
|
3 Participants
|
|
Number of Participants With Adverse Events
Hypernatremia
|
1 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events
Hyperuricemia
|
2 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events
Hypoalbuminemia
|
18 Participants
|
20 Participants
|
|
Number of Participants With Adverse Events
Hypocalcemia
|
25 Participants
|
22 Participants
|
|
Number of Participants With Adverse Events
Hypokalemia
|
16 Participants
|
16 Participants
|
|
Number of Participants With Adverse Events
Hyponatremia
|
4 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events
Hypophosphatemia
|
40 Participants
|
35 Participants
|
|
Number of Participants With Adverse Events
Bone pain
|
4 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events
Muscle cramps-back/legs
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events
Right thigh/leg pain
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events
Acitinic Keratosis (right shoulder)
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events
Headache
|
1 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events
Reversible posterior leukoencephalopathy syndrome
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events
Syncope
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events
Tremor
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events
Anxiety
|
0 Participants
|
2 Participants
|
|
Number of Participants With Adverse Events
Delirium
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events
Insomnia
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events
Hematuria
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events
Proteinuria
|
0 Participants
|
2 Participants
|
|
Number of Participants With Adverse Events
Cough
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events
Dyspnea
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events
Hypoxia
|
8 Participants
|
5 Participants
|
|
Number of Participants With Adverse Events
Pleural effusion
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events
Pulmonary edema
|
1 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events
Wheezing
|
1 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events
Erythematous nodules
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events
Pruritus
|
0 Participants
|
2 Participants
|
|
Number of Participants With Adverse Events
Rash acneiform
|
2 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events
Rash maculo-papular
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events
Skin lesion
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events
Flushing
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events
Hematoma
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events
Hypertension
|
1 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events
Hypotension
|
5 Participants
|
12 Participants
|
|
Number of Participants With Adverse Events
Phlebitis
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events
Thromboembolic event
|
3 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events
Atrial flutter
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
Myocardial infarction
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
Palpitations
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
Supraventricular tachycardia
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
Adrenal insufficiency
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
SIADH
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
Dyspepsia
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
Dysphagia
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
Hemorrhoidal hemorrhage
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
Odynophagia
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
Chills
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
Multi-organ failure
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
Non-cardiac chest pain
|
2 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
Bacteremia - Gram Positive
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
Bacteremia-Serratia liquefaciens/pantoea species
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
Catheter related infection
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
CMV viremia
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
Esophageal infection
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
Otitis media
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
Rhinitis infective
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
Alanine aminotransferase increased
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
Alkaline phosphatase increased
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
INR increased
|
3 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
Hyperglycemia
|
3 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
Uncontrolled Diabetes Mellitus
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
Generalized muscle weakness
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
Jaw pain
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
Joint effusion
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
Encephalopathy
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
Peripheral sensory neuropathy
|
2 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
Presyncope
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
Acute kidney injury
|
2 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
Urinary frequency
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
Urinary retention
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
Urinary tract pain
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
Scrotal pain
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
Atelectasis
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
Epistaxis
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
Hiccups
|
2 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
Pneumonitis
|
2 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
Productive cough
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
Respiratory failure
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
Sore throat
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
Facial rash/dermatitis
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
Follicular rash-back/posterior neck
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
Rash forehead/back
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
Skin ulceration
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsOverall response rate=CR+sCR+VGPR+PR Complete response (CR), disappearance of monoclonal protein from the blood \& urine and \<5% plasma cells in bone marrow \&disappearance of soft tissue plasmacytomas Stringent complete response (sCR), CR \& normal free light chain ratio \& absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence Very good partial response (VGPR), serum and urine monoclonal protein detectable by immunofixation but not on electrophoresis OR \> 90% reduction in serum monoclonal protein with urine monoclonal protein \< 100 mg per 24 hours and if present, \> 50% reduction in the size of soft tissue plasmacytomas Partial response (PR), \> 50% reduction in the level of the serum monoclonal protein \& reduction in urine monoclonal protein \& \> 50% reduction in the size of soft tissue plasmacytomas \& if serum and urine monoclonal protein are unmeasurable and serum free light chain is unmeasurable, a \> 50% reduction in plasma cells is required
Outcome measures
| Measure |
Experimental: Granix and High Dose Melphalan (HDM)
n=44 Participants
Granix on Day -7 through Day -2.
HDM intravenously (IV) on Day -2.
Autologous stem cell transplantation on Day 0
|
Control: High Dose Melphalan (HDM)
n=45 Participants
HDM intravenously (IV) on Day -2.
|
|---|---|---|
|
Number of Participants With Overall Response
|
41 Participants
|
42 Participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsOS is defined as the duration from the time of transplant Day 0 to death or last follow-up.
Outcome measures
| Measure |
Experimental: Granix and High Dose Melphalan (HDM)
n=44 Participants
Granix on Day -7 through Day -2.
HDM intravenously (IV) on Day -2.
Autologous stem cell transplantation on Day 0
|
Control: High Dose Melphalan (HDM)
n=45 Participants
HDM intravenously (IV) on Day -2.
|
|---|---|---|
|
Overall Survival as Measured by Number of Participants Alive at Last Follow-up
|
40 Participants
|
43 Participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsPFS is defined as the duration from time of transplant Day 0 to time of first progression/clinical relapse, death, or the date the patient was last known to be in remission
Outcome measures
| Measure |
Experimental: Granix and High Dose Melphalan (HDM)
n=44 Participants
Granix on Day -7 through Day -2.
HDM intravenously (IV) on Day -2.
Autologous stem cell transplantation on Day 0
|
Control: High Dose Melphalan (HDM)
n=45 Participants
HDM intravenously (IV) on Day -2.
|
|---|---|---|
|
Progression-free Survival as Measured by Number of Participants Without Disease Progression at Last Follow-up
|
37 Participants
|
36 Participants
|
SECONDARY outcome
Timeframe: Up to Day 30Neutrophil engraftment is defined as ANC ≥ 0.5 × 10\^9/L × 3 consecutive daily assessments. The first of 3 consecutive days for which ANC ≥ 0.5 × 109/L will be recorded as the date of neutrophil engraftment. Time to neutrophil engraftment will be calculated as the time from the date of the ASCT to the date of neutrophil engraftment.
Outcome measures
| Measure |
Experimental: Granix and High Dose Melphalan (HDM)
n=44 Participants
Granix on Day -7 through Day -2.
HDM intravenously (IV) on Day -2.
Autologous stem cell transplantation on Day 0
|
Control: High Dose Melphalan (HDM)
n=45 Participants
HDM intravenously (IV) on Day -2.
|
|---|---|---|
|
Number of Participants With Neutrophil Engraftment
|
44 Participants
|
45 Participants
|
SECONDARY outcome
Timeframe: Up to Day 100Population: 1 participant in control arm did not have a decrease in platelets and is not evaluable for this outcome measure.
Platelet engraftment is defined as an untransfused platelet measurement \>20,000/mm3 × 3 consecutive daily assessments. The first of 3 consecutive days for which the untransfused platelet measurement is \>20,000/mm3 will be recorded as the date of platelet engraftment. Time to platelet engraftment will be calculated as the time from receiving the date of ASCT to the date of platelet engraftment. Untransfused is defined as no transfusions within 7 days.
Outcome measures
| Measure |
Experimental: Granix and High Dose Melphalan (HDM)
n=44 Participants
Granix on Day -7 through Day -2.
HDM intravenously (IV) on Day -2.
Autologous stem cell transplantation on Day 0
|
Control: High Dose Melphalan (HDM)
n=44 Participants
HDM intravenously (IV) on Day -2.
|
|---|---|---|
|
Number of Participants With Platelet Engraftment
|
44 Participants
|
44 Participants
|
Adverse Events
Experimental: Granix and High Dose Melphalan (HDM)
Serious events: 10 serious events
Other events: 45 other events
Deaths: 40 deaths
Control: High Dose Melphalan (HDM)
Serious events: 4 serious events
Other events: 45 other events
Deaths: 43 deaths
Serious adverse events
| Measure |
Experimental: Granix and High Dose Melphalan (HDM)
n=45 participants at risk
Granix on Day -7 through Day -2.
HDM intravenously (IV) on Day -2.
Autologous stem cell transplantation on Day 0
|
Control: High Dose Melphalan (HDM)
n=45 participants at risk
HDM intravenously (IV) on Day -2.
|
|---|---|---|
|
Cardiac disorders
Atrial filbrillation
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Gastrointestinal disorders
Colonic perforation
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Gastrointestinal disorders
Dehydration
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
General disorders
Fever
|
6.7%
3/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Infections and infestations
Clostridium difficile
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Infections and infestations
Lung infection
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Infections and infestations
Rhinitis Infective
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Infections and infestations
Sepsis
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Vascular disorders
Thromboembolic event
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
Other adverse events
| Measure |
Experimental: Granix and High Dose Melphalan (HDM)
n=45 participants at risk
Granix on Day -7 through Day -2.
HDM intravenously (IV) on Day -2.
Autologous stem cell transplantation on Day 0
|
Control: High Dose Melphalan (HDM)
n=45 participants at risk
HDM intravenously (IV) on Day -2.
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
66.7%
30/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
60.0%
27/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Cardiac disorders
Atrial fibrillation
|
6.7%
3/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Cardiac disorders
Atrial flutter
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Cardiac disorders
Myocardial infarction
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Cardiac disorders
Palpitations
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Cardiac disorders
Sinus tachycardia
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
6.7%
3/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Cardiac disorders
Supraventricular tachycardia
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Ear and labyrinth disorders
Excessive cerumen
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Ear and labyrinth disorders
Impacted cerumen
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Endocrine disorders
Adrenal insufficiency
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Endocrine disorders
SIADH
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Eye disorders
Dry eye
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Gastrointestinal disorders
Abdominal pain
|
4.4%
2/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Gastrointestinal disorders
Diarrhea
|
11.1%
5/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
24.4%
11/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Gastrointestinal disorders
Dyspepsia
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Gastrointestinal disorders
Dysphagia
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Gastrointestinal disorders
Epigastric pain
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
4.4%
2/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Gastrointestinal disorders
Mucositis oral
|
35.6%
16/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
31.1%
14/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Gastrointestinal disorders
Nausea
|
6.7%
3/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
11.1%
5/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Gastrointestinal disorders
Odynophagia
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Gastrointestinal disorders
Oral pain
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
General disorders
Chills
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
General disorders
Edema limbs
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
General disorders
Fever
|
6.7%
3/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
6.7%
3/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
General disorders
Infusion related reaction
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
General disorders
Malaise
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
General disorders
Multi-organ failure
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
General disorders
Non-cardiac chest pain
|
4.4%
2/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
General disorders
Pain
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Immune system disorders
Allergic reaction
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Infections and infestations
Bacteremia-Coagulase negative staphylococcus
|
4.4%
2/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Infections and infestations
Bacteremia-Enterobacter Clocae
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Infections and infestations
Bacteremia-Fusobacterium
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Infections and infestations
Bacteremia-Gram positive
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Infections and infestations
Bacteremia-MSSA
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Infections and infestations
Bacteremia-Pseudomonas aeruginosa
|
6.7%
3/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Infections and infestations
Bacteremia-Serratia liquefaciens/pantoea species
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Infections and infestations
Bacteremia-Streptococcus mitis
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Infections and infestations
Bleeding from CVC insertion site
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Infections and infestations
CMV viremia
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Infections and infestations
Candida (groan)
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Infections and infestations
Catheter related infection
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Infections and infestations
Clostridium difficile
|
4.4%
2/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Infections and infestations
Esophageal infection
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Infections and infestations
Fall
|
4.4%
2/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Infections and infestations
Lung infection
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
4.4%
2/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Infections and infestations
Mucosal infection (oral thrush)
|
22.2%
10/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
24.4%
11/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Infections and infestations
Peri-rectal yeast infection
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Infections and infestations
Skin infection
|
6.7%
3/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
6.7%
3/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Infections and infestations
Splenic infection
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Infections and infestations
Upper respiratory infection
|
4.4%
2/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
8.9%
4/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
8.9%
4/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Infections and infestations
Vaginal infection
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Investigations
Alanine aminotransferase increased
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Investigations
Alkaline phosphatase increased
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Investigations
Aspartate aminotransferase incrased
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Investigations
Blood bilirubin increased
|
6.7%
3/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
4.4%
2/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Investigations
Creatinine increased
|
8.9%
4/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
6.7%
3/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Investigations
Hyperglycemia
|
6.7%
3/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Investigations
INR increased
|
6.7%
3/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Investigations
Weight loss
|
13.3%
6/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Metabolism and nutrition disorders
Anorexia
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Metabolism and nutrition disorders
Dehydration
|
13.3%
6/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
6.7%
3/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
4.4%
2/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
40.0%
18/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
44.4%
20/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
55.6%
25/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
48.9%
22/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
35.6%
16/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
35.6%
16/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
8.9%
4/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
88.9%
40/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
77.8%
35/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Metabolism and nutrition disorders
Muscle cramps-back/legs
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Metabolism and nutrition disorders
Uncontrolled diabetes mellitus
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
8.9%
4/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Musculoskeletal and connective tissue disorders
Jaw pain
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Musculoskeletal and connective tissue disorders
Right thigh/leg pain
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Actinic Keratosis (right shoulder)
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Nervous system disorders
Encephalopathy
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Nervous system disorders
Headache
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
4.4%
2/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Nervous system disorders
Presyncope
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Nervous system disorders
Reversible posterior leukoencephalopathy syndrome
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Nervous system disorders
Syncope
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Nervous system disorders
Tremor
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
4.4%
2/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
4.4%
2/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Renal and urinary disorders
Urinary frequency
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Renal and urinary disorders
Urinary retention
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Reproductive system and breast disorders
Scrotal pain
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
4.4%
2/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
17.8%
8/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
11.1%
5/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
4.4%
2/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Skin and subcutaneous tissue disorders
Erythematous nodules
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Skin and subcutaneous tissue disorders
Facial rash/dermatitis
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Skin and subcutaneous tissue disorders
Follicular rash-back/posterior neck
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
4.4%
2/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
4.4%
2/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Skin and subcutaneous tissue disorders
Rash forehead/back
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Vascular disorders
Flushing
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Vascular disorders
Hematoma
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Vascular disorders
Hypertension
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Vascular disorders
Hypotension
|
11.1%
5/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
26.7%
12/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
|
Vascular disorders
Thromboembolic event
|
4.4%
2/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
2.2%
1/45 • Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
|
Additional Information
Meagan Jacoby, M.D., Ph.D.
Washington University School of Medicine
Phone: 314-454-8304
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place