Trial Outcomes & Findings for E7070, Idarubicin and Cytarabine in Relapsed AML and High-Risk Myelodysplastic Syndromes (NCT NCT01692197)
NCT ID: NCT01692197
Last Updated: 2018-07-03
Results Overview
Efficacy measured by overall response - complete response plus complete response with incomplete platelet recovery, plus partial response (Complete remission (CR) + Complete remission without platelet recovery (CRp) + Partial Remission (PR)+ marrow clearance of blast) during cycle 1.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
43 participants
Primary outcome timeframe
2 cycles (60 days)
Results posted on
2018-07-03
Participant Flow
Recruitment Period: 2/2013 to 06/2014
Of the 43 participants registered, three never received the study medication.
Participant milestones
| Measure |
E7070 and Idarubicin and Cytarabine
E7070 400 mg/m2 intravenously (IV) approximately over 1 hour on day 1 and day 8:
Idarubicin 8 mg/m2 IV approximately over 1 hour daily x 3 (days 9-11) Cytarabine 1.0 g/m2 IV approximately over 24 hours daily on day 9-12 (age \<60 years) or days 9-11 (age ≥ 60 years).
Dexamethasone 10 mg IV daily for 3-4 days with cytarabine (Duration is approximately 28 days).
|
|---|---|
|
Overall Study
STARTED
|
43
|
|
Overall Study
COMPLETED
|
40
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
E7070 and Idarubicin and Cytarabine
E7070 400 mg/m2 intravenously (IV) approximately over 1 hour on day 1 and day 8:
Idarubicin 8 mg/m2 IV approximately over 1 hour daily x 3 (days 9-11) Cytarabine 1.0 g/m2 IV approximately over 24 hours daily on day 9-12 (age \<60 years) or days 9-11 (age ≥ 60 years).
Dexamethasone 10 mg IV daily for 3-4 days with cytarabine (Duration is approximately 28 days).
|
|---|---|
|
Overall Study
Failed Screening
|
3
|
Baseline Characteristics
E7070, Idarubicin and Cytarabine in Relapsed AML and High-Risk Myelodysplastic Syndromes
Baseline characteristics by cohort
| Measure |
E7070 and Idarubicin and Cytarabine
n=43 Participants
E7070 400 mg/m2 intravenously (IV) approximately over 1 hour on day 1 and day 8:
Idarubicin 8 mg/m2 IV approximately over 1 hour daily x 3 (days 9-11) Cytarabine 1.0 g/m2 IV approximately over 24 hours daily on day 9-12 (age \<60 years) or days 9-11 (age ≥ 60 years).
Dexamethasone 10 mg IV daily for 3-4 days with cytarabine (Duration is approximately 28 days).
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
18 Participants
n=5 Participants
|
|
Age, Continuous
|
63 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
43 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 cycles (60 days)Population: Thirty seven patients are evaluable.
Efficacy measured by overall response - complete response plus complete response with incomplete platelet recovery, plus partial response (Complete remission (CR) + Complete remission without platelet recovery (CRp) + Partial Remission (PR)+ marrow clearance of blast) during cycle 1.
Outcome measures
| Measure |
E7070 and Idarubicin and Cytarabine
n=37 Participants
E7070 400 mg/m2 intravenously (IV) approximately over 1 hour on day 1 and day 8:
Idarubicin 8 mg/m2 IV approximately over 1 hour daily x 3 (days 9-11) Cytarabine 1.0 g/m2 IV approximately over 24 hours daily on day 9-12 (age \<60 years) or days 9-11 (age ≥ 60 years).
Dexamethasone 10 mg IV daily for 3-4 days with cytarabine (Duration is approximately 28 days).
|
|---|---|
|
Overall Response
|
11 Participants
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Thirty seven patients are evaluable.
Time from date of treatment start until the date of first objective documentation of disease-relapse.
Outcome measures
| Measure |
E7070 and Idarubicin and Cytarabine
n=37 Participants
E7070 400 mg/m2 intravenously (IV) approximately over 1 hour on day 1 and day 8:
Idarubicin 8 mg/m2 IV approximately over 1 hour daily x 3 (days 9-11) Cytarabine 1.0 g/m2 IV approximately over 24 hours daily on day 9-12 (age \<60 years) or days 9-11 (age ≥ 60 years).
Dexamethasone 10 mg IV daily for 3-4 days with cytarabine (Duration is approximately 28 days).
|
|---|---|
|
Disease-free Survival
|
1.7 months
Interval 1.0 to 42.0
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Thirty seven patients are evaluable.
Response date to loss of response or last follow up.
Outcome measures
| Measure |
E7070 and Idarubicin and Cytarabine
n=37 Participants
E7070 400 mg/m2 intravenously (IV) approximately over 1 hour on day 1 and day 8:
Idarubicin 8 mg/m2 IV approximately over 1 hour daily x 3 (days 9-11) Cytarabine 1.0 g/m2 IV approximately over 24 hours daily on day 9-12 (age \<60 years) or days 9-11 (age ≥ 60 years).
Dexamethasone 10 mg IV daily for 3-4 days with cytarabine (Duration is approximately 28 days).
|
|---|---|
|
Duration of Response
|
6.7 months
Interval 1.0 to 13.0
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Thirty seven patients are evaluable.
Time from date of treatment start until date of death due to any cause or last follow-up.
Outcome measures
| Measure |
E7070 and Idarubicin and Cytarabine
n=37 Participants
E7070 400 mg/m2 intravenously (IV) approximately over 1 hour on day 1 and day 8:
Idarubicin 8 mg/m2 IV approximately over 1 hour daily x 3 (days 9-11) Cytarabine 1.0 g/m2 IV approximately over 24 hours daily on day 9-12 (age \<60 years) or days 9-11 (age ≥ 60 years).
Dexamethasone 10 mg IV daily for 3-4 days with cytarabine (Duration is approximately 28 days).
|
|---|---|
|
Overall Survival
|
5.1 months
Interval 1.0 to 42.0
|
Adverse Events
E7070 and Idarubicin and Cytarabine
Serious events: 30 serious events
Other events: 38 other events
Deaths: 11 deaths
Serious adverse events
| Measure |
E7070 and Idarubicin and Cytarabine
n=40 participants at risk
E7070 400 mg/m2 intravenously (IV) approximately over 1 hour on day 1 and day 8:
Idarubicin 8 mg/m2 IV approximately over 1 hour daily x 3 (days 9-11) Cytarabine 1.0 g/m2 IV approximately over 24 hours daily on day 9-12 (age \<60 years) or days 9-11 (age ≥ 60 years).
Dexamethasone 10 mg IV daily for 3-4 days with cytarabine (Duration is approximately 28 days).
|
|---|---|
|
General disorders
Allergic Reaction
|
2.5%
1/40 • Number of events 1 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
Cardiac disorders
Atrial Fibrillation
|
2.5%
1/40 • Number of events 2 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
General disorders
Back Pain
|
2.5%
1/40 • Number of events 1 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
General disorders
Bone Marrow Hypocellular
|
2.5%
1/40 • Number of events 1 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
General disorders
Bone Pain
|
2.5%
1/40 • Number of events 1 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
Cardiac disorders
Cardiac Arrest
|
2.5%
1/40 • Number of events 1 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
Cardiac disorders
Chest Pain
|
2.5%
1/40 • Number of events 1 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
General disorders
Death
|
5.0%
2/40 • Number of events 2 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.5%
1/40 • Number of events 1 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
Infections and infestations
Infective Endocarditis
|
2.5%
1/40 • Number of events 1 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
General disorders
Fall
|
2.5%
1/40 • Number of events 1 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
General disorders
Fatigue
|
2.5%
1/40 • Number of events 1 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
Infections and infestations
Febrile Neutropenia
|
35.0%
14/40 • Number of events 18 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
General disorders
Fever
|
2.5%
1/40 • Number of events 1 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
Cardiac disorders
Heart Failure
|
2.5%
1/40 • Number of events 1 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
Renal and urinary disorders
Hematuria
|
2.5%
1/40 • Number of events 2 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
Cardiac disorders
Hypotension
|
2.5%
1/40 • Number of events 1 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
Investigations
Injection Site Reaction
|
2.5%
1/40 • Number of events 1 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
Blood and lymphatic system disorders
Intracranial Hemorrhage
|
2.5%
1/40 • Number of events 1 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
Infections and infestations
Joint Infection
|
2.5%
1/40 • Number of events 2 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
Infections and infestations
Lung Infection
|
27.5%
11/40 • Number of events 15 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
General disorders
Multi-Organ Failure
|
2.5%
1/40 • Number of events 1 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
Infections and infestations
Pelvic Infection
|
2.5%
1/40 • Number of events 1 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
Blood and lymphatic system disorders
Pulmonary edema
|
2.5%
1/40 • Number of events 1 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
Infections and infestations
Sepsis
|
22.5%
9/40 • Number of events 10 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
Infections and infestations
Skin Infection
|
7.5%
3/40 • Number of events 3 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
Nervous system disorders
Syncope
|
2.5%
1/40 • Number of events 1 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
Blood and lymphatic system disorders
Thromboembolic event
|
2.5%
1/40 • Number of events 1 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
Infections and infestations
Upper Respiratory Infection
|
2.5%
1/40 • Number of events 1 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
Infections and infestations
Wound Infection
|
2.5%
1/40 • Number of events 1 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
Other adverse events
| Measure |
E7070 and Idarubicin and Cytarabine
n=40 participants at risk
E7070 400 mg/m2 intravenously (IV) approximately over 1 hour on day 1 and day 8:
Idarubicin 8 mg/m2 IV approximately over 1 hour daily x 3 (days 9-11) Cytarabine 1.0 g/m2 IV approximately over 24 hours daily on day 9-12 (age \<60 years) or days 9-11 (age ≥ 60 years).
Dexamethasone 10 mg IV daily for 3-4 days with cytarabine (Duration is approximately 28 days).
|
|---|---|
|
General disorders
Pain
|
15.0%
6/40 • Number of events 7 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
Renal and urinary disorders
Acute Kidney injury
|
5.0%
2/40 • Number of events 2 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
Nervous system disorders
Agitation
|
5.0%
2/40 • Number of events 2 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
Metabolism and nutrition disorders
Increased Alanine Aminotransferase
|
22.5%
9/40 • Number of events 15 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
Metabolism and nutrition disorders
Increased Alkaline Phosphatase
|
15.0%
6/40 • Number of events 12 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.0%
2/40 • Number of events 2 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
Gastrointestinal disorders
Anorexia
|
27.5%
11/40 • Number of events 11 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
Nervous system disorders
Anxiety
|
5.0%
2/40 • Number of events 2 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.0%
2/40 • Number of events 3 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
Metabolism and nutrition disorders
Increased Aspartate Aminotransferase
|
20.0%
8/40 • Number of events 11 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
Cardiac disorders
Atrial Fibrillation
|
7.5%
3/40 • Number of events 3 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
Metabolism and nutrition disorders
Hyperbilirubinemia
|
35.0%
14/40 • Number of events 28 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
Cardiac disorders
Increased Cardiac Troponin I
|
5.0%
2/40 • Number of events 2 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
Cardiac disorders
Chest Pain
|
7.5%
3/40 • Number of events 3 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
General disorders
Chills
|
5.0%
2/40 • Number of events 2 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
Nervous system disorders
Confusion
|
10.0%
4/40 • Number of events 4 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
Gastrointestinal disorders
Constipation
|
32.5%
13/40 • Number of events 16 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
17.5%
7/40 • Number of events 7 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
Metabolism and nutrition disorders
Increased Creatinine
|
22.5%
9/40 • Number of events 12 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
Gastrointestinal disorders
Dehydration
|
7.5%
3/40 • Number of events 3 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
Nervous system disorders
Depression
|
7.5%
3/40 • Number of events 3 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
Gastrointestinal disorders
Diarrhea
|
42.5%
17/40 • Number of events 17 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
General disorders
Dizziness
|
17.5%
7/40 • Number of events 7 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
Gastrointestinal disorders
Dry Mouth
|
5.0%
2/40 • Number of events 2 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
Gastrointestinal disorders
Dysgeusia
|
10.0%
4/40 • Number of events 4 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
27.5%
11/40 • Number of events 11 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
Blood and lymphatic system disorders
Edema
|
35.0%
14/40 • Number of events 16 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
Blood and lymphatic system disorders
Epistaxis
|
7.5%
3/40 • Number of events 3 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
Eye disorders
Eye Disorders
|
5.0%
2/40 • Number of events 2 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
General disorders
Fatigue
|
40.0%
16/40 • Number of events 17 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
Infections and infestations
Neutropenic Fever
|
25.0%
10/40 • Number of events 13 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
General disorders
Fever
|
20.0%
8/40 • Number of events 10 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
5.0%
2/40 • Number of events 2 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
20.0%
8/40 • Number of events 11 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
Nervous system disorders
Hallucinations
|
7.5%
3/40 • Number of events 3 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
General disorders
Headache
|
17.5%
7/40 • Number of events 8 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
Blood and lymphatic system disorders
Hematoma
|
5.0%
2/40 • Number of events 2 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
Gastrointestinal disorders
Hemorrhoids
|
5.0%
2/40 • Number of events 2 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
Gastrointestinal disorders
Hiccups
|
7.5%
3/40 • Number of events 3 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
5.0%
2/40 • Number of events 2 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
32.5%
13/40 • Number of events 29 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
10.0%
4/40 • Number of events 6 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
7.5%
3/40 • Number of events 3 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
Cardiac disorders
Hypertension
|
5.0%
2/40 • Number of events 6 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
25.0%
10/40 • Number of events 33 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
30.0%
12/40 • Number of events 23 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
42.5%
17/40 • Number of events 33 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
40.0%
16/40 • Number of events 20 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
25.0%
10/40 • Number of events 20 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
25.0%
10/40 • Number of events 20 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
Cardiac disorders
Hypotension
|
12.5%
5/40 • Number of events 5 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
7.5%
3/40 • Number of events 3 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
General disorders
Insomnia
|
15.0%
6/40 • Number of events 6 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
General disorders
Lethargy
|
5.0%
2/40 • Number of events 2 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
General disorders
malaise
|
7.5%
3/40 • Number of events 3 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
Gastrointestinal disorders
Oral Mucositis
|
7.5%
3/40 • Number of events 3 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
General disorders
Nasal Congestion
|
5.0%
2/40 • Number of events 2 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
Gastrointestinal disorders
Nausea
|
52.5%
21/40 • Number of events 26 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
10.0%
4/40 • Number of events 4 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
5.0%
2/40 • Number of events 2 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorders
|
7.5%
3/40 • Number of events 4 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
Cardiac disorders
Sinus Tachycardia
|
12.5%
5/40 • Number of events 5 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
Skin and subcutaneous tissue disorders
Skin and Subcutaneous tissue disorders
|
32.5%
13/40 • Number of events 14 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
Gastrointestinal disorders
Sore Throat
|
5.0%
2/40 • Number of events 2 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
Surgical and medical procedures
Surgical and Medical Procedures
|
7.5%
3/40 • Number of events 3 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
Renal and urinary disorders
Urinary Retention
|
5.0%
2/40 • Number of events 3 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
Gastrointestinal disorders
Vomiting
|
22.5%
9/40 • Number of events 12 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
5.0%
2/40 • Number of events 2 • Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place