Trial Outcomes & Findings for Mitoxantrone, Etoposide, and Cytarabine (MEC) Plus Lenalidomide for Relapsed or Refractory Acute Myeloid Leukemia (NCT NCT03118466)
NCT ID: NCT03118466
Last Updated: 2025-10-15
Results Overview
Percentage of patients who have achieve CR or CRp after treatment. * Morphologic Complete Remission (CR): Defined as morphologic leukemia-free state, including \<5% blasts in Bone Marrow aspirate with marrow spicules, no persistent extramedullary disease, ANC \>1000/mm3 and platelet count \>100,000/mm3. * Morphologic Complete Remission without platelet recovery (CRp): Defined as CR with the exception of platelet count \< 100,000/mm3 (CRp).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
41 participants
Primary outcome timeframe
up to 45 days
Results posted on
2025-10-15
Participant Flow
One patient came off study prior to receiving any treatment and was replaced. A total of 40 patients received study treatment.
Participant milestones
| Measure |
Lenalidomide and MEC chemotherapy
Lenalidomide is taken orally on a daily basis days 1-10. Mitoxantrone, Etoposide, and Cytarabine are administered intravenously on a daily basis for days 4 through 8 of the treatment. There is only one cycle of treatment in this study.
Etoposide: A Drug that interfere with the action of topoisomerase enzymes (topoisomerase I and II). Topoisomerase enzymes control the manipulation of the structure of DNA necessary for replication.
Cytarabine: Cytarabine is an antimetabolite antineoplastic agent that inhibits the synthesis of DNA.
Lenalidomide: It may act by inhibiting the growth of new blood vessels (angiogenesis) in tumors, enhancing the status of the immune system, or decreasing cytokine and growth factor production
Mitoxantrone: It interfere with cell reproduction
|
|---|---|
|
Overall Study
STARTED
|
40
|
|
Overall Study
COMPLETED
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Lenalidomide and MEC chemotherapy
n=40 Participants
Lenalidomide is taken orally on a daily basis days 1-10. Mitoxantrone, Etoposide, and Cytarabine are administered intravenously on a daily basis for days 4 through 8 of the treatment. There is only one cycle of treatment in this study.
Etoposide: A Drug that interfere with the action of topoisomerase enzymes (topoisomerase I and II). Topoisomerase enzymes control the manipulation of the structure of DNA necessary for replication.
Cytarabine: Cytarabine is an antimetabolite antineoplastic agent that inhibits the synthesis of DNA.
Lenalidomide: It may act by inhibiting the growth of new blood vessels (angiogenesis) in tumors, enhancing the status of the immune system, or decreasing cytokine and growth factor production
Mitoxantrone: It interfere with cell reproduction
|
|---|---|
|
Age, Continuous
|
56 years
n=40 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=40 Participants
|
|
Region of Enrollment
United States
|
40 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: up to 45 daysPercentage of patients who have achieve CR or CRp after treatment. * Morphologic Complete Remission (CR): Defined as morphologic leukemia-free state, including \<5% blasts in Bone Marrow aspirate with marrow spicules, no persistent extramedullary disease, ANC \>1000/mm3 and platelet count \>100,000/mm3. * Morphologic Complete Remission without platelet recovery (CRp): Defined as CR with the exception of platelet count \< 100,000/mm3 (CRp).
Outcome measures
| Measure |
Lenalidomide and MEC chemotherapy
n=40 Participants
Lenalidomide is taken orally on a daily basis days 1-10. Mitoxantrone, Etoposide, and Cytarabine are administered intravenously on a daily basis for days 4 through 8 of the treatment. There is only one cycle of treatment in this study.
Etoposide: A Drug that interfere with the action of topoisomerase enzymes (topoisomerase I and II). Topoisomerase enzymes control the manipulation of the structure of DNA necessary for replication.
Cytarabine: Cytarabine is an antimetabolite antineoplastic agent that inhibits the synthesis of DNA.
Lenalidomide: It may act by inhibiting the growth of new blood vessels (angiogenesis) in tumors, enhancing the status of the immune system, or decreasing cytokine and growth factor production
Mitoxantrone: It interfere with cell reproduction
|
|---|---|
|
Complete Response Rate
|
19 Participants
|
SECONDARY outcome
Timeframe: up to 45 daysThe number of patients that achieved a neutrophil count of \> 500/mm3 for 3 days within 45 of starting treatment
Outcome measures
| Measure |
Lenalidomide and MEC chemotherapy
n=40 Participants
Lenalidomide is taken orally on a daily basis days 1-10. Mitoxantrone, Etoposide, and Cytarabine are administered intravenously on a daily basis for days 4 through 8 of the treatment. There is only one cycle of treatment in this study.
Etoposide: A Drug that interfere with the action of topoisomerase enzymes (topoisomerase I and II). Topoisomerase enzymes control the manipulation of the structure of DNA necessary for replication.
Cytarabine: Cytarabine is an antimetabolite antineoplastic agent that inhibits the synthesis of DNA.
Lenalidomide: It may act by inhibiting the growth of new blood vessels (angiogenesis) in tumors, enhancing the status of the immune system, or decreasing cytokine and growth factor production
Mitoxantrone: It interfere with cell reproduction
|
|---|---|
|
Number of Patients That Achieved ANC Recovery
|
25 Participants
|
SECONDARY outcome
Timeframe: up to 45 daysThe number of patients that achieved a stable platelet count \> 20,000/mm3 for 3 days within 45 days of starting treatment
Outcome measures
| Measure |
Lenalidomide and MEC chemotherapy
n=40 Participants
Lenalidomide is taken orally on a daily basis days 1-10. Mitoxantrone, Etoposide, and Cytarabine are administered intravenously on a daily basis for days 4 through 8 of the treatment. There is only one cycle of treatment in this study.
Etoposide: A Drug that interfere with the action of topoisomerase enzymes (topoisomerase I and II). Topoisomerase enzymes control the manipulation of the structure of DNA necessary for replication.
Cytarabine: Cytarabine is an antimetabolite antineoplastic agent that inhibits the synthesis of DNA.
Lenalidomide: It may act by inhibiting the growth of new blood vessels (angiogenesis) in tumors, enhancing the status of the immune system, or decreasing cytokine and growth factor production
Mitoxantrone: It interfere with cell reproduction
|
|---|---|
|
Number of Patients That Achieved Platelet Recovery
|
27 Participants
|
SECONDARY outcome
Timeframe: 50 daysCumulative number of deaths not related to persistent or relapsed leukemia during treatment within 50 days of the start of treatment.
Outcome measures
| Measure |
Lenalidomide and MEC chemotherapy
n=40 Participants
Lenalidomide is taken orally on a daily basis days 1-10. Mitoxantrone, Etoposide, and Cytarabine are administered intravenously on a daily basis for days 4 through 8 of the treatment. There is only one cycle of treatment in this study.
Etoposide: A Drug that interfere with the action of topoisomerase enzymes (topoisomerase I and II). Topoisomerase enzymes control the manipulation of the structure of DNA necessary for replication.
Cytarabine: Cytarabine is an antimetabolite antineoplastic agent that inhibits the synthesis of DNA.
Lenalidomide: It may act by inhibiting the growth of new blood vessels (angiogenesis) in tumors, enhancing the status of the immune system, or decreasing cytokine and growth factor production
Mitoxantrone: It interfere with cell reproduction
|
|---|---|
|
Treatment-related Mortality
|
2 Participants
|
SECONDARY outcome
Timeframe: 50 daysNumber of red blood cell and platelet transfusions received within the first 50 days of treatment
Outcome measures
| Measure |
Lenalidomide and MEC chemotherapy
n=40 Participants
Lenalidomide is taken orally on a daily basis days 1-10. Mitoxantrone, Etoposide, and Cytarabine are administered intravenously on a daily basis for days 4 through 8 of the treatment. There is only one cycle of treatment in this study.
Etoposide: A Drug that interfere with the action of topoisomerase enzymes (topoisomerase I and II). Topoisomerase enzymes control the manipulation of the structure of DNA necessary for replication.
Cytarabine: Cytarabine is an antimetabolite antineoplastic agent that inhibits the synthesis of DNA.
Lenalidomide: It may act by inhibiting the growth of new blood vessels (angiogenesis) in tumors, enhancing the status of the immune system, or decreasing cytokine and growth factor production
Mitoxantrone: It interfere with cell reproduction
|
|---|---|
|
Transfusion Support: Number of Red Blood Cell and Platelet Transfusions
Platelet Transfusions
|
7 Number of Transfusions
Interval 2.0 to 49.0
|
|
Transfusion Support: Number of Red Blood Cell and Platelet Transfusions
Red Blood Cell Transfusions
|
9 Number of Transfusions
Interval 1.0 to 47.0
|
SECONDARY outcome
Timeframe: Up to 3 yearsOverall survival is defined as time from diagnosis of disease until date of death or censored on the last known date alive if patients are still alive.
Outcome measures
| Measure |
Lenalidomide and MEC chemotherapy
n=40 Participants
Lenalidomide is taken orally on a daily basis days 1-10. Mitoxantrone, Etoposide, and Cytarabine are administered intravenously on a daily basis for days 4 through 8 of the treatment. There is only one cycle of treatment in this study.
Etoposide: A Drug that interfere with the action of topoisomerase enzymes (topoisomerase I and II). Topoisomerase enzymes control the manipulation of the structure of DNA necessary for replication.
Cytarabine: Cytarabine is an antimetabolite antineoplastic agent that inhibits the synthesis of DNA.
Lenalidomide: It may act by inhibiting the growth of new blood vessels (angiogenesis) in tumors, enhancing the status of the immune system, or decreasing cytokine and growth factor production
Mitoxantrone: It interfere with cell reproduction
|
|---|---|
|
Overall Survival
|
16 Months
Interval 13.0 to
Upper limit of confidence interval not defined due to insufficient number of events
|
SECONDARY outcome
Timeframe: Up to 3 yearsRelapse-Free Survival is defined as time from diagnosis of disease until date of relapse, death, or censored on the last known date alive if patients are still alive.Relapse is defined by morphological evidence of the original malignancy consistent with pre-treatment features.
Outcome measures
| Measure |
Lenalidomide and MEC chemotherapy
n=40 Participants
Lenalidomide is taken orally on a daily basis days 1-10. Mitoxantrone, Etoposide, and Cytarabine are administered intravenously on a daily basis for days 4 through 8 of the treatment. There is only one cycle of treatment in this study.
Etoposide: A Drug that interfere with the action of topoisomerase enzymes (topoisomerase I and II). Topoisomerase enzymes control the manipulation of the structure of DNA necessary for replication.
Cytarabine: Cytarabine is an antimetabolite antineoplastic agent that inhibits the synthesis of DNA.
Lenalidomide: It may act by inhibiting the growth of new blood vessels (angiogenesis) in tumors, enhancing the status of the immune system, or decreasing cytokine and growth factor production
Mitoxantrone: It interfere with cell reproduction
|
|---|---|
|
Relapse-Free Survival
|
13.1 months
Interval 10.2 to
95% CI is 10.2 - NR; Upper limit of confidence interval not defined due to insufficient number of events
|
Adverse Events
Lenalidomide and MEC chemotherapy
Serious events: 19 serious events
Other events: 40 other events
Deaths: 15 deaths
Serious adverse events
| Measure |
Lenalidomide and MEC chemotherapy
n=40 participants at risk
Lenalidomide is taken orally on a daily basis days 1-10. Mitoxantrone, Etoposide, and Cytarabine are administered intravenously on a daily basis for days 4 through 8 of the treatment. There is only one cycle of treatment in this study.
Etoposide: A Drug that interfere with the action of topoisomerase enzymes (topoisomerase I and II). Topoisomerase enzymes control the manipulation of the structure of DNA necessary for replication.
Cytarabine: Cytarabine is an antimetabolite antineoplastic agent that inhibits the synthesis of DNA.
Lenalidomide: It may act by inhibiting the growth of new blood vessels (angiogenesis) in tumors, enhancing the status of the immune system, or decreasing cytokine and growth factor production
Mitoxantrone: It interfere with cell reproduction
|
|---|---|
|
Gastrointestinal disorders
Colonic obstruction
|
2.5%
1/40 • Number of events 1 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Gastrointestinal disorders
Mucositis oral
|
2.5%
1/40 • Number of events 1 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
2.5%
1/40 • Number of events 1 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Hepatobiliary disorders
Hepatic failure
|
2.5%
1/40 • Number of events 5 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Infections and infestations
Abdominal infection
|
2.5%
1/40 • Number of events 1 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Infections and infestations
Hepatic infection
|
2.5%
1/40 • Number of events 1 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Infections and infestations
Sepsis
|
2.5%
1/40 • Number of events 3 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Infections and infestations
Infections and infestations - Other, candidemia sepsis
|
2.5%
1/40 • Number of events 1 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Infections and infestations
Infections and infestations - Other, Enterococcus faecium bacteremia
|
2.5%
1/40 • Number of events 1 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Investigations
Blood bilirubin increased
|
2.5%
1/40 • Number of events 2 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Investigations
Creatinine increased
|
2.5%
1/40 • Number of events 1 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Investigations
Ejection fraction decreased
|
2.5%
1/40 • Number of events 1 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Nervous system disorders
Encephalopathy
|
2.5%
1/40 • Number of events 1 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Nervous system disorders
Intracranial hemorrhage
|
2.5%
1/40 • Number of events 1 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
2.5%
1/40 • Number of events 1 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.5%
1/40 • Number of events 1 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.5%
1/40 • Number of events 1 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.5%
1/40 • Number of events 1 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Renal and urinary disorders
Acute kidney injury
|
2.5%
1/40 • Number of events 1 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Vascular disorders
Hypotension
|
2.5%
1/40 • Number of events 3 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
Other adverse events
| Measure |
Lenalidomide and MEC chemotherapy
n=40 participants at risk
Lenalidomide is taken orally on a daily basis days 1-10. Mitoxantrone, Etoposide, and Cytarabine are administered intravenously on a daily basis for days 4 through 8 of the treatment. There is only one cycle of treatment in this study.
Etoposide: A Drug that interfere with the action of topoisomerase enzymes (topoisomerase I and II). Topoisomerase enzymes control the manipulation of the structure of DNA necessary for replication.
Cytarabine: Cytarabine is an antimetabolite antineoplastic agent that inhibits the synthesis of DNA.
Lenalidomide: It may act by inhibiting the growth of new blood vessels (angiogenesis) in tumors, enhancing the status of the immune system, or decreasing cytokine and growth factor production
Mitoxantrone: It interfere with cell reproduction
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
20/40 • Number of events 33 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
67.5%
27/40 • Number of events 37 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Cardiac disorders
Sinus bradycardia
|
5.0%
2/40 • Number of events 2 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Cardiac disorders
Sinus tachycardia
|
12.5%
5/40 • Number of events 7 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
General Disorders
Chills
|
12.5%
5/40 • Number of events 5 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
General Disorders
Edema face
|
10.0%
4/40 • Number of events 5 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
General Disorders
Edema limbs
|
37.5%
15/40 • Number of events 17 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
General Disorders
Fatigue
|
50.0%
20/40 • Number of events 25 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
General Disorders
Fever
|
40.0%
16/40 • Number of events 21 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
General Disorders
Malaise
|
7.5%
3/40 • Number of events 3 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
General Disorders
Non-cardiac chest pain
|
5.0%
2/40 • Number of events 2 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
22.5%
9/40 • Number of events 10 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
32.5%
13/40 • Number of events 22 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Gastrointestinal disorders
Abdominal distension
|
5.0%
2/40 • Number of events 2 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Gastrointestinal disorders
Abdominal pain
|
27.5%
11/40 • Number of events 21 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Gastrointestinal disorders
Bloating
|
5.0%
2/40 • Number of events 3 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Gastrointestinal disorders
Colitis
|
12.5%
5/40 • Number of events 6 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Gastrointestinal disorders
Constipation
|
25.0%
10/40 • Number of events 12 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
55.0%
22/40 • Number of events 31 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Gastrointestinal disorders
Dry mouth
|
10.0%
4/40 • Number of events 4 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Gastrointestinal disorders
Dyspepsia
|
7.5%
3/40 • Number of events 3 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Gastrointestinal disorders
Enterocolitis
|
5.0%
2/40 • Number of events 2 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Gastrointestinal disorders
Esophageal pain
|
5.0%
2/40 • Number of events 2 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Gastrointestinal disorders
Esophagitis
|
5.0%
2/40 • Number of events 2 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Gastrointestinal disorders
Fecal incontinence
|
5.0%
2/40 • Number of events 2 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
10.0%
4/40 • Number of events 4 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Gastrointestinal disorders
Gingival pain
|
5.0%
2/40 • Number of events 2 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Gastrointestinal disorders
Hemorrhoids
|
17.5%
7/40 • Number of events 9 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
5.0%
2/40 • Number of events 2 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Gastrointestinal disorders
Mucositis oral
|
25.0%
10/40 • Number of events 12 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Gastrointestinal disorders
Nausea
|
55.0%
22/40 • Number of events 27 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Gastrointestinal disorders
Oral pain
|
10.0%
4/40 • Number of events 5 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Gastrointestinal disorders
Rectal pain
|
12.5%
5/40 • Number of events 10 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Gastrointestinal disorders
Typhlitis
|
5.0%
2/40 • Number of events 2 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Gastrointestinal disorders
Vomiting
|
30.0%
12/40 • Number of events 14 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Infections and infestations
Catheter related infection
|
12.5%
5/40 • Number of events 5 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Infections and infestations
Lung infection
|
15.0%
6/40 • Number of events 7 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Infections and infestations
Skin infection
|
10.0%
4/40 • Number of events 4 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Investigations
Alanine aminotransferase increased
|
27.5%
11/40 • Number of events 21 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Investigations
Alkaline phosphatase increased
|
12.5%
5/40 • Number of events 9 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Investigations
Aspartate aminotransferase increased
|
25.0%
10/40 • Number of events 16 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Investigations
Blood bilirubin increased
|
20.0%
8/40 • Number of events 17 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Investigations
Creatinine increased
|
7.5%
3/40 • Number of events 3 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Investigations
INR increased
|
7.5%
3/40 • Number of events 5 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Investigations
Lymphocyte count decreased
|
7.5%
3/40 • Number of events 6 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Investigations
Neutrophil count decreased
|
30.0%
12/40 • Number of events 21 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Investigations
Platelet count decreased
|
55.0%
22/40 • Number of events 63 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Investigations
Weight loss
|
7.5%
3/40 • Number of events 8 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Investigations
White blood cell decreased
|
12.5%
5/40 • Number of events 10 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Metabolism and nutrition disorders
Anorexia
|
45.0%
18/40 • Number of events 29 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
5.0%
2/40 • Number of events 2 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
5.0%
2/40 • Number of events 2 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
22.5%
9/40 • Number of events 10 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
22.5%
9/40 • Number of events 10 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
32.5%
13/40 • Number of events 38 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
15.0%
6/40 • Number of events 7 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
15.0%
6/40 • Number of events 7 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
35.0%
14/40 • Number of events 30 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.0%
6/40 • Number of events 7 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
12.5%
5/40 • Number of events 5 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
10.0%
4/40 • Number of events 4 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.0%
2/40 • Number of events 2 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
7.5%
3/40 • Number of events 3 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.0%
4/40 • Number of events 4 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder -
|
5.0%
2/40 • Number of events 2 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Nervous system disorders
Depressed level of consciousness
|
5.0%
2/40 • Number of events 2 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Nervous system disorders
Dizziness
|
22.5%
9/40 • Number of events 11 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Nervous system disorders
Dysgeusia
|
10.0%
4/40 • Number of events 5 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Nervous system disorders
Headache
|
25.0%
10/40 • Number of events 13 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Nervous system disorders
Paresthesia
|
5.0%
2/40 • Number of events 2 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Nervous system disorders
Somnolence
|
5.0%
2/40 • Number of events 2 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Nervous system disorders
Syncope
|
10.0%
4/40 • Number of events 4 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Eye disorders
Blurred vision
|
10.0%
4/40 • Number of events 4 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Eye disorders
Dry eye
|
7.5%
3/40 • Number of events 3 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Psychiatric disorders
Anxiety
|
15.0%
6/40 • Number of events 6 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Psychiatric disorders
Depression
|
7.5%
3/40 • Number of events 3 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Psychiatric disorders
Insomnia
|
27.5%
11/40 • Number of events 12 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
30.0%
12/40 • Number of events 16 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.0%
8/40 • Number of events 8 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
10.0%
4/40 • Number of events 4 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
7.5%
3/40 • Number of events 3 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
10.0%
4/40 • Number of events 5 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.0%
2/40 • Number of events 3 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Renal and urinary disorders
Hematuria
|
7.5%
3/40 • Number of events 3 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
5.0%
2/40 • Number of events 3 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Vascular disorders
Flushing
|
7.5%
3/40 • Number of events 3 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Vascular disorders
Hematoma
|
5.0%
2/40 • Number of events 2 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Vascular disorders
Hypertension
|
5.0%
2/40 • Number of events 2 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Vascular disorders
Hypotension
|
42.5%
17/40 • Number of events 22 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
|
Vascular disorders
Thromboembolic event
|
7.5%
3/40 • Number of events 4 • From the start of treatment until 30 days after the end of study treatment, up to 3 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place