Trial Outcomes & Findings for Study of Melphalan HCl for Injection (Propylene Glycol-free), Carmustine, Etoposide, Cytarabine (BEAM Regimen) and Autologous Stem Cell Transplantation for Lymphoma (NCT NCT01969435)
NCT ID: NCT01969435
Last Updated: 2018-02-13
Results Overview
Adverse events will be assessed using the National Cancer Institute (NCI)-CTCAE version 4.0. Number of events, grade 2 or higher, occurring in 10% or greater of participants. Grade 2 diarrhea and Grade 2 nausea/vomiting were not recorded.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
Day -7 through Day 30
Results posted on
2018-02-13
Participant Flow
Participant milestones
| Measure |
Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)
* Day -7, carmustine intravenous (IV) infusion
* Days -6, -5, -4, and -3, etoposide and cytarabine (IV) infusions twice a day
* Day -2, melphalan HCl (propylene glycol-free)(IV) infusion
* Day 0, stem cell transplant.
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
COMPLETED
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Melphalan HCl for Injection (Propylene Glycol-free), Carmustine, Etoposide, Cytarabine (BEAM Regimen) and Autologous Stem Cell Transplantation for Lymphoma
Baseline characteristics by cohort
| Measure |
Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)
n=50 Participants
* Day -7, carmustine intravenous (IV) infusion
* Days -6, -5, -4, and -3, etoposide and cytarabine (IV) infusions twice a day
* Day -2, melphalan HCl (propylene glycol-free)(IV) infusion
* Day 0, stem cell transplant.
|
|---|---|
|
Age, Continuous
|
51 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=5 Participants
|
|
Diagnosis
Hodgkin lymphoma
|
17 participants
n=5 Participants
|
|
Diagnosis
Diffuse large B-cell lymphoma
|
15 participants
n=5 Participants
|
|
Diagnosis
Mantle cell lymphoma
|
8 participants
n=5 Participants
|
|
Diagnosis
Other Non-Hodgkin Lymphoma
|
10 participants
n=5 Participants
|
|
Remission status prior to autologous stem cell transplant
Complete remission
|
23 participants
n=5 Participants
|
|
Remission status prior to autologous stem cell transplant
Partial remission
|
25 participants
n=5 Participants
|
|
Remission status prior to autologous stem cell transplant
Progressive disease
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day -7 through Day 30Adverse events will be assessed using the National Cancer Institute (NCI)-CTCAE version 4.0. Number of events, grade 2 or higher, occurring in 10% or greater of participants. Grade 2 diarrhea and Grade 2 nausea/vomiting were not recorded.
Outcome measures
| Measure |
Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)
n=50 Participants
* Day -7, carmustine intravenous (IV) infusion
* Days -6, -5, -4, and -3, etoposide and cytarabine (IV) infusions twice a day
* Day -2, melphalan HCl (propylene glycol-free)(IV) infusion
* Day 0, stem cell transplant.
|
|---|---|
|
Safety and Toxicity as Measured by Treatment Related Non-hematologic Adverse Events
Fever neutropenia
|
34 participants
|
|
Safety and Toxicity as Measured by Treatment Related Non-hematologic Adverse Events
Fever
|
6 participants
|
|
Safety and Toxicity as Measured by Treatment Related Non-hematologic Adverse Events
Bacteremia
|
7 participants
|
|
Safety and Toxicity as Measured by Treatment Related Non-hematologic Adverse Events
Clostridium difficile
|
3 participants
|
|
Safety and Toxicity as Measured by Treatment Related Non-hematologic Adverse Events
Respiratory infection
|
5 participants
|
|
Safety and Toxicity as Measured by Treatment Related Non-hematologic Adverse Events
Mucosal infection
|
7 participants
|
|
Safety and Toxicity as Measured by Treatment Related Non-hematologic Adverse Events
Skin infection
|
3 participants
|
|
Safety and Toxicity as Measured by Treatment Related Non-hematologic Adverse Events
Genito-urinary tract infection
|
3 participants
|
|
Safety and Toxicity as Measured by Treatment Related Non-hematologic Adverse Events
Hypotension
|
15 participants
|
|
Safety and Toxicity as Measured by Treatment Related Non-hematologic Adverse Events
Abdominal pain
|
5 participants
|
|
Safety and Toxicity as Measured by Treatment Related Non-hematologic Adverse Events
Diarrhea
|
8 participants
|
|
Safety and Toxicity as Measured by Treatment Related Non-hematologic Adverse Events
Mucositis oral
|
27 participants
|
|
Safety and Toxicity as Measured by Treatment Related Non-hematologic Adverse Events
Liver enzymes increased
|
5 participants
|
|
Safety and Toxicity as Measured by Treatment Related Non-hematologic Adverse Events
Bilirubin increased
|
5 participants
|
|
Safety and Toxicity as Measured by Treatment Related Non-hematologic Adverse Events
Dehydration
|
5 participants
|
|
Safety and Toxicity as Measured by Treatment Related Non-hematologic Adverse Events
Hyperglycemia
|
6 participants
|
|
Safety and Toxicity as Measured by Treatment Related Non-hematologic Adverse Events
Hypoalbuminemia
|
10 participants
|
|
Safety and Toxicity as Measured by Treatment Related Non-hematologic Adverse Events
Hypocalcemia
|
12 participants
|
|
Safety and Toxicity as Measured by Treatment Related Non-hematologic Adverse Events
Hypokalemia
|
14 participants
|
|
Safety and Toxicity as Measured by Treatment Related Non-hematologic Adverse Events
Hypophosphatemia
|
35 participants
|
|
Safety and Toxicity as Measured by Treatment Related Non-hematologic Adverse Events
Pain
|
10 participants
|
|
Safety and Toxicity as Measured by Treatment Related Non-hematologic Adverse Events
Headache
|
7 participants
|
|
Safety and Toxicity as Measured by Treatment Related Non-hematologic Adverse Events
Hypoxia
|
9 participants
|
|
Safety and Toxicity as Measured by Treatment Related Non-hematologic Adverse Events
Rash
|
8 participants
|
PRIMARY outcome
Timeframe: 100 daysTRM is defined as death not due to progressive lymphoma prior to Day 100 after transplant
Outcome measures
| Measure |
Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)
n=50 Participants
* Day -7, carmustine intravenous (IV) infusion
* Days -6, -5, -4, and -3, etoposide and cytarabine (IV) infusions twice a day
* Day -2, melphalan HCl (propylene glycol-free)(IV) infusion
* Day 0, stem cell transplant.
|
|---|---|
|
Treatment-related Mortality (TRM)
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Up to Day 100* The response rates according to each category of response Complete Response (CR), Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD) will be summarized by the proportion of patients meeting each criterion. * Evaluated using PET or CT scan and Revised Response Criteria for Malignant Lymphoma
Outcome measures
| Measure |
Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)
n=50 Participants
* Day -7, carmustine intravenous (IV) infusion
* Days -6, -5, -4, and -3, etoposide and cytarabine (IV) infusions twice a day
* Day -2, melphalan HCl (propylene glycol-free)(IV) infusion
* Day 0, stem cell transplant.
|
|---|---|
|
Efficacy as Measured by Response Rates
Complete response
|
84 percentage of participants
|
|
Efficacy as Measured by Response Rates
Partial response
|
4 percentage of participants
|
|
Efficacy as Measured by Response Rates
Stable disease
|
0 percentage of participants
|
|
Efficacy as Measured by Response Rates
Progressive disease
|
12 percentage of participants
|
SECONDARY outcome
Timeframe: 1 yearPercentage of patients who survive without any signs or symptoms of cancer at 1 year.
Outcome measures
| Measure |
Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)
n=50 Participants
* Day -7, carmustine intravenous (IV) infusion
* Days -6, -5, -4, and -3, etoposide and cytarabine (IV) infusions twice a day
* Day -2, melphalan HCl (propylene glycol-free)(IV) infusion
* Day 0, stem cell transplant.
|
|---|---|
|
Disease-free Survival
|
70 percentage of participants
Interval 58.0 to 85.0
|
SECONDARY outcome
Timeframe: 2 yearsPercentage of patients who survive without any signs or symptoms of cancer at 2 years.
Outcome measures
| Measure |
Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)
n=50 Participants
* Day -7, carmustine intravenous (IV) infusion
* Days -6, -5, -4, and -3, etoposide and cytarabine (IV) infusions twice a day
* Day -2, melphalan HCl (propylene glycol-free)(IV) infusion
* Day 0, stem cell transplant.
|
|---|---|
|
Disease-free Survival
|
64 percentage of participants
|
SECONDARY outcome
Timeframe: Assessed up to day 30Time from the date of the transplant to the date of neutrophil engraftment.
Outcome measures
| Measure |
Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)
n=50 Participants
* Day -7, carmustine intravenous (IV) infusion
* Days -6, -5, -4, and -3, etoposide and cytarabine (IV) infusions twice a day
* Day -2, melphalan HCl (propylene glycol-free)(IV) infusion
* Day 0, stem cell transplant.
|
|---|---|
|
Time to Engraftment (Neutrophil)
|
10 days
Interval 9.0 to 13.0
|
SECONDARY outcome
Timeframe: Assessed up to day 100Population: One patient did not have platelet engraftment by Day 100
Time from the date of transplant to the date of platelet engraftment.
Outcome measures
| Measure |
Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)
n=49 Participants
* Day -7, carmustine intravenous (IV) infusion
* Days -6, -5, -4, and -3, etoposide and cytarabine (IV) infusions twice a day
* Day -2, melphalan HCl (propylene glycol-free)(IV) infusion
* Day 0, stem cell transplant.
|
|---|---|
|
Time to Engraftment (Platelet)
|
19 days
Interval 12.0 to 90.0
|
POST_HOC outcome
Timeframe: 6 monthsPFS - Time from start of treatment to the time of progression or death, whichever occurs first.
Outcome measures
| Measure |
Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)
n=50 Participants
* Day -7, carmustine intravenous (IV) infusion
* Days -6, -5, -4, and -3, etoposide and cytarabine (IV) infusions twice a day
* Day -2, melphalan HCl (propylene glycol-free)(IV) infusion
* Day 0, stem cell transplant.
|
|---|---|
|
Progression-free Survival (PFS) Rate
|
84 percentage of participants
Interval 74.0 to 95.0
|
POST_HOC outcome
Timeframe: 1 yearOutcome measures
| Measure |
Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)
n=50 Participants
* Day -7, carmustine intravenous (IV) infusion
* Days -6, -5, -4, and -3, etoposide and cytarabine (IV) infusions twice a day
* Day -2, melphalan HCl (propylene glycol-free)(IV) infusion
* Day 0, stem cell transplant.
|
|---|---|
|
Progression-free Survival Rate (PFS)
|
70 percentage of participants
Interval 58.0 to 85.0
|
POST_HOC outcome
Timeframe: 1 yearOutcome measures
| Measure |
Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)
n=50 Participants
* Day -7, carmustine intravenous (IV) infusion
* Days -6, -5, -4, and -3, etoposide and cytarabine (IV) infusions twice a day
* Day -2, melphalan HCl (propylene glycol-free)(IV) infusion
* Day 0, stem cell transplant.
|
|---|---|
|
Relapse Free Survival
|
0 percentage of participants
|
POST_HOC outcome
Timeframe: Median follow-up 15.4 months (range 4.7-24.6)Outcome measures
| Measure |
Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)
n=50 Participants
* Day -7, carmustine intravenous (IV) infusion
* Days -6, -5, -4, and -3, etoposide and cytarabine (IV) infusions twice a day
* Day -2, melphalan HCl (propylene glycol-free)(IV) infusion
* Day 0, stem cell transplant.
|
|---|---|
|
Overall Survival (OS) Rate
|
10 percentage of participants
|
Adverse Events
Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)
Serious events: 1 serious events
Other events: 50 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)
n=50 participants at risk
* Day -7, carmustine intravenous (IV) infusion
* Days -6, -5, -4, and -3, etoposide and cytarabine (IV) infusions twice a day
* Day -2, melphalan HCl (propylene glycol-free)(IV) infusion
* Day 0, stem cell transplant.
|
|---|---|
|
General disorders
Multi-organ failure due to sepsis
|
2.0%
1/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
Other adverse events
| Measure |
Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)
n=50 participants at risk
* Day -7, carmustine intravenous (IV) infusion
* Days -6, -5, -4, and -3, etoposide and cytarabine (IV) infusions twice a day
* Day -2, melphalan HCl (propylene glycol-free)(IV) infusion
* Day 0, stem cell transplant.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
5/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Investigations
Alanine aminotransferase increased
|
6.0%
3/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Investigations
Alkaline phosphatase increased
|
2.0%
1/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Immune system disorders
Allergic reaction
|
4.0%
2/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Metabolism and nutrition disorders
Anorexia
|
6.0%
3/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Investigations
Aspartate aminotransferase increased
|
2.0%
1/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
2.0%
1/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Cardiac disorders
Atrial fibrillation
|
6.0%
3/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Respiratory, thoracic and mediastinal disorders
BCNU pulmonary toxicity
|
2.0%
1/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.0%
2/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Investigations
Blood bilirubin increased
|
10.0%
5/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Infections and infestations
Blood-Coagulase-negative staphylococcus
|
6.0%
3/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Infections and infestations
Blood-Enterobacter clocae/streptococcus mitis
|
2.0%
1/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Infections and infestations
Blood-Klebsiella pneumoniae
|
4.0%
2/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.0%
3/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Infections and infestations
Catheter related infection
|
2.0%
1/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
General disorders
Chills
|
4.0%
2/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Infections and infestations
Clostridium difficile
|
6.0%
3/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Gastrointestinal disorders
Colitis
|
4.0%
2/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Gastrointestinal disorders
Constipation
|
2.0%
1/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.0%
1/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Investigations
Creatinine increased
|
2.0%
1/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Metabolism and nutrition disorders
Dehydration
|
10.0%
5/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Gastrointestinal disorders
Diarrhea
|
16.0%
8/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Nervous system disorders
Dizziness
|
2.0%
1/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.0%
1/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
General disorders
Edema limbs
|
4.0%
2/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
6.0%
3/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Gastrointestinal disorders
Esophageal spasm
|
2.0%
1/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Injury, poisoning and procedural complications
Fall
|
2.0%
1/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Infections and infestations
Febrile neutropenia
|
68.0%
34/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
General disorders
Fever
|
12.0%
6/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Vascular disorders
Flushing
|
4.0%
2/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Skin and subcutaneous tissue disorders
Folliculitis
|
2.0%
1/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
2.0%
1/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
6.0%
3/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
8.0%
4/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Infections and infestations
HSV (oral)
|
4.0%
2/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Nervous system disorders
Headache
|
14.0%
7/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Cardiac disorders
Heart failure
|
2.0%
1/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Renal and urinary disorders
Hematuria
|
2.0%
1/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Gastrointestinal disorders
Hemorrhoids
|
8.0%
4/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Musculoskeletal and connective tissue disorders
Hip pain
|
2.0%
1/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
12.0%
6/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
2.0%
1/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Vascular disorders
Hypertension
|
2.0%
1/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
20.0%
10/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
24.0%
12/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
28.0%
14/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
2.0%
1/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.0%
1/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
70.0%
35/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Vascular disorders
Hypotension
|
30.0%
15/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
18.0%
9/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Gastrointestinal disorders
Ileal obstruction
|
2.0%
1/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Psychiatric disorders
Insomnia
|
2.0%
1/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Nervous system disorders
Lethargy
|
2.0%
1/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
General disorders
Localized edema
|
2.0%
1/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
2.0%
1/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Infections and infestations
Lung infection
|
2.0%
1/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Infections and infestations
Mucosal infection (oral candidiasis)
|
10.0%
5/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Gastrointestinal disorders
Mucositis oral
|
54.0%
27/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.0%
1/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Gastrointestinal disorders
Nausea
|
4.0%
2/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
General disorders
Non-cardiac chest pain
|
8.0%
4/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.0%
4/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Infections and infestations
Parainfluenaza virus type 3
|
2.0%
1/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.0%
1/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
2.0%
1/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.0%
1/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
16.0%
8/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Gastrointestinal disorders
Rectal pain
|
4.0%
2/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.0%
1/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Cardiac disorders
Sinus tachycardia
|
2.0%
1/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Infections and infestations
Sinusitis
|
4.0%
2/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Infections and infestations
Skin infection
|
6.0%
3/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
4.0%
2/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Skin and subcutaneous tissue disorders
Subcutaneous nodule
|
2.0%
1/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Cardiac disorders
Supraventricular tachycardia
|
2.0%
1/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Nervous system disorders
Syncope
|
2.0%
1/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Vascular disorders
Thromboembolic event
|
4.0%
2/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Infections and infestations
Upper respiratory infection
|
2.0%
1/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Renal and urinary disorders
Urinary retention
|
2.0%
1/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Infections and infestations
Urinary tract infection
|
4.0%
2/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Infections and infestations
Vaginal infection
|
2.0%
1/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
1/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Investigations
Weight gain
|
2.0%
1/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
|
Investigations
Weight loss
|
8.0%
4/50 • Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Reportable adverse events are events grade 2 or higher. Hematologic adverse events are expected and therefore the following adverse events were not collected/reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events were expected and not collected/reported: nausea, vomiting, diarrhea, anorexia, fatigue, and alopecia.
|
Additional Information
Amanda F. Cashen, M.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