Trial Outcomes & Findings for Safety and Efficacy of Marqibo in Relapsed Acute Lymphoblastic Leukemia (NCT NCT00495079)
NCT ID: NCT00495079
Last Updated: 2021-03-05
Results Overview
CR is defined as no evidence of ALL: ANC\>or=1x10\^9/L or platelet count\>100x10\^9/L, absence of leukemia blast cells in blood and marrow (\<5% blasts), resolution of all sites of extramedullary disease (EMD). CR with incomplete blood count recovery (CRi): As per CR but platelet count\< 100x10\^9/L or ANC\< 1x10\^9/L. Partial remission(PR):CR with\>5-25% abnormal cells in the marrow or 50% decrease in bone marrow blasts. Reduction in EMD by at least 50%. Hematologic Improvement. Bone marrow blast(BMB) response: BMB\<5% in the absence of HI. Stable disease(SD):No significant hematological and extramedullary change from baseline.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
65 participants
Primary outcome timeframe
Response assessment performed at the end of each 28 day course.
Results posted on
2021-03-05
Participant Flow
Subjects were enrolled and treated at 22 sites in United States, Canada, Germany, Israel and United Kingdom. The first subject was infused on August 2, 2007. The last subject completed study on August 8, 2010.
2.25 mg/m\^2 Marqibo administered intravenously via peripheral or central venous access over 60 minutes (+-10 minutes)
Participant milestones
| Measure |
Marqibo
Eligible subjects received study drug at 2.25 mg/m2 intravenously via peripheral or central venous access over 60 minutes (± 10 minutes).
|
|---|---|
|
Overall Study
STARTED
|
65
|
|
Overall Study
COMPLETED
|
65
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of Marqibo in Relapsed Acute Lymphoblastic Leukemia
Baseline characteristics by cohort
| Measure |
Marqibo
n=65 Participants
Eligible subjects received study drug at 2.25 mg/m2 intravenously via peripheral or central venous access over 60 minutes (± 10 minutes).
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
59 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
|
Age, Continuous
|
36.3 years
STANDARD_DEVIATION 16.37 • n=5 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
53 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
6 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Response assessment performed at the end of each 28 day course.Population: Subjects who had CR plus CRi by the PI and the IRRC assessments using the International Working Group Criteria. The Intent-to-Treat Analysis, n=65, minimum 1 dose. The IRRC, n=53, 1 dose, assess response as determined by the IRRC. Analyses, a Simon's 2-stage minimax design where the type I error alpha was set at 0.10 and the power was 80%.
CR is defined as no evidence of ALL: ANC\>or=1x10\^9/L or platelet count\>100x10\^9/L, absence of leukemia blast cells in blood and marrow (\<5% blasts), resolution of all sites of extramedullary disease (EMD). CR with incomplete blood count recovery (CRi): As per CR but platelet count\< 100x10\^9/L or ANC\< 1x10\^9/L. Partial remission(PR):CR with\>5-25% abnormal cells in the marrow or 50% decrease in bone marrow blasts. Reduction in EMD by at least 50%. Hematologic Improvement. Bone marrow blast(BMB) response: BMB\<5% in the absence of HI. Stable disease(SD):No significant hematological and extramedullary change from baseline.
Outcome measures
| Measure |
Marqibo
n=65 Participants
Eligible subjects received study drug at 2.25 mg/m2 intravenously via peripheral or central venous access over 60 minutes (± 10 minutes).
|
|---|---|
|
Complete Remission Plus Complete Remission Without Full Platelet Recovery (CR + CRi)
|
13 participants
Interval 11.1 to 31.8
|
PRIMARY outcome
Timeframe: Response assessment at the end of each 28 days coursePopulation: The IRRC evaluable population included all subjects who received at least 1 dose of study drug and who has reviewable data to assess and determine response or lack of response as determined by the IRRC.
Number of subjects who achieved Complete Remission (CR)as assessed by the IRRC. CR is defined as no evidence of ALL. ANC\>=1X10\^9/L or Platelet count\>=100x10\^9/L, absence of blasts in blood and morrow (\<5%), resolution of all sites of extramedullary disease (EMD). CR with incomplete blood count recovery(CRi)is defined as per CR but platelet count \<100x10\^9/L or ANC\<1x10\^9/L.
Outcome measures
| Measure |
Marqibo
n=53 Participants
Eligible subjects received study drug at 2.25 mg/m2 intravenously via peripheral or central venous access over 60 minutes (± 10 minutes).
|
|---|---|
|
Clinical Response Assessment Per Independent Response Review Committee (IRRC) Evaluation
|
11 participants
Interval 10.8 to 34.1
|
SECONDARY outcome
Timeframe: CR + CRi duration was calculated from the date the subject first met the definition of CR or CRi until the date of relapsePopulation: Based on the first date of CR or CRi to the date of the last available histologic assessment of the same response (n=8)
Duration of response for those subjects who achieved CR or CRi
Outcome measures
| Measure |
Marqibo
n=8 Participants
Eligible subjects received study drug at 2.25 mg/m2 intravenously via peripheral or central venous access over 60 minutes (± 10 minutes).
|
|---|---|
|
Duration of CR + CRi
|
28 days
Interval 7.0 to 36.0
|
SECONDARY outcome
Timeframe: unlimitedPopulation: Based on the first date of CR or CRi to date of documented relapse, death, or subsequent chemotherapies including hematopoietic stem cell transplant (HSCT)(n=10)
Time, in days, from informed consent date until the date of death or date of last contact
Outcome measures
| Measure |
Marqibo
n=10 Participants
Eligible subjects received study drug at 2.25 mg/m2 intravenously via peripheral or central venous access over 60 minutes (± 10 minutes).
|
|---|---|
|
Overall Survival
|
56 days
Interval 9.0 to 65.0
|
Adverse Events
Marqibo
Serious events: 21 serious events
Other events: 65 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Marqibo
n=65 participants at risk
Eligible subjects received study drug at 2.25 mg/m2 intravenously via peripheral or central venous access over 60 minutes (± 10 minutes).
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
18.5%
12/65 • Number of events 12 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.5%
1/65 • Number of events 1 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Blood and lymphatic system disorders
Anaemia
|
1.5%
1/65 • Number of events 1 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Blood and lymphatic system disorders
Pancytopenia
|
1.5%
1/65 • Number of events 1 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.1%
2/65 • Number of events 2 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Gastrointestinal disorders
Abdominal pain
|
1.5%
1/65 • Number of events 1 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Gastrointestinal disorders
Constipation
|
3.1%
2/65 • Number of events 2 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Gastrointestinal disorders
Diarrhoea
|
4.6%
3/65 • Number of events 3 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.5%
1/65 • Number of events 1 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Gastrointestinal disorders
Ileus
|
1.5%
1/65 • Number of events 1 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Gastrointestinal disorders
Nausea
|
1.5%
1/65 • Number of events 1 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Gastrointestinal disorders
Subileus
|
1.5%
1/65 • Number of events 1 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Gastrointestinal disorders
Vomiting
|
1.5%
1/65 • Number of events 1 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Nervous system disorders
Neuropathy, peripheral
|
6.2%
4/65 • Number of events 4 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Nervous system disorders
Facial palsy
|
1.5%
1/65 • Number of events 1 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Nervous system disorders
Peripheral sensory neuropath
|
1.5%
1/65 • Number of events 1 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
4.6%
3/65 • Number of events 3 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.5%
1/65 • Number of events 1 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.5%
1/65 • Number of events 1 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
General disorders
Pyrexia
|
1.5%
1/65 • Number of events 1 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Infections and infestations
Bacteraemia
|
1.5%
1/65 • Number of events 1 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Infections and infestations
Staphylococcal bacteraemia
|
1.5%
1/65 • Number of events 1 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Hepatobiliary disorders
Cholecystitis, chronic
|
1.5%
1/65 • Number of events 1 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
1.5%
1/65 • Number of events 1 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
4.6%
3/65 • Number of events 3 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Vascular disorders
Venoocclusive disease
|
1.5%
1/65 • Number of events 1 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Cardiac disorders
Cardiac arrest
|
1.5%
1/65 • Number of events 1 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
1.5%
1/65 • Number of events 1 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Immune system disorders
Graft versus host disease
|
1.5%
1/65 • Number of events 1 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.5%
1/65 • Number of events 1 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphocytic leukaemia
|
1.5%
1/65 • Number of events 1 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Infections and infestations
Pneumonia
|
1.5%
1/65 • Number of events 1 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Infections and infestations
Sepsis
|
3.1%
2/65 • Number of events 2 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Infections and infestations
Septic Shock
|
3.1%
2/65 • Number of events 2 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Infections and infestations
Acute Sinusitis
|
1.5%
1/65 • Number of events 1 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Infections and infestations
Bronchiectasis
|
1.5%
1/65 • Number of events 1 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Infections and infestations
Bronchopulmonary Aspergillosis
|
1.5%
1/65 • Number of events 1 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Infections and infestations
Cellulitis
|
1.5%
1/65 • Number of events 1 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Infections and infestations
Entrocococcal Bacteraemia
|
1.5%
1/65 • Number of events 1 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Infections and infestations
Escherichia Sepsis
|
1.5%
1/65 • Number of events 1 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Infections and infestations
Klebsiella Sepsis
|
1.5%
1/65 • Number of events 1 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Infections and infestations
Neutropenic Sepsis
|
1.5%
1/65 • Number of events 1 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Infections and infestations
Parainfluenzae Virus Infection
|
1.5%
1/65 • Number of events 1 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Infections and infestations
Pneumonia Bacterial
|
1.5%
1/65 • Number of events 1 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Infections and infestations
Rhinitis
|
1.5%
1/65 • Number of events 1 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Infections and infestations
Sinusitis
|
1.5%
1/65 • Number of events 1 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute Lymphocytic Leukemia
|
13.8%
9/65 • Number of events 9 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute Lymphocytic Leukaemia Recurrent
|
1.5%
1/65 • Number of events 1 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia
|
1.5%
1/65 • Number of events 1 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia Infiltration Brain
|
1.5%
1/65 • Number of events 1 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
4.6%
3/65 • Number of events 3 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.5%
1/65 • Number of events 1 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.5%
1/65 • Number of events 1 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Haemorrhage
|
1.5%
1/65 • Number of events 1 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Nervous system disorders
Cerebral Infarction
|
1.5%
1/65 • Number of events 1 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Nervous system disorders
Convulsion
|
1.5%
1/65 • Number of events 1 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Nervous system disorders
Heamorrhage Intracranial
|
1.5%
1/65 • Number of events 1 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Nervous system disorders
Peripheral Motor Neuropathy
|
1.5%
1/65 • Number of events 1 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
General disorders
Gait Disturbance
|
1.5%
1/65 • Number of events 1 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
General disorders
Multi-Organ Failure
|
1.5%
1/65 • Number of events 1 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
General disorders
Pain
|
1.5%
1/65 • Number of events 1 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Cardiac disorders
Cardiac Arrest
|
4.6%
3/65 • Number of events 3 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Cardiac disorders
Cardio-Respiratory Arrest
|
3.1%
2/65 • Number of events 2 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Cardiac disorders
Cardiogenic Shock
|
1.5%
1/65 • Number of events 1 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Cardiac disorders
Cardiomyopathy
|
1.5%
1/65 • Number of events 1 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Metabolism and nutrition disorders
Dehydration
|
1.5%
1/65 • Number of events 1 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Vascular disorders
Hypotension
|
3.1%
2/65 • Number of events 2 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Psychiatric disorders
Mental Status Changes
|
3.1%
2/65 • Number of events 2 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Renal and urinary disorders
Cystitis Haemorrhagic
|
1.5%
1/65 • Number of events 1 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Renal and urinary disorders
Renal Failure
|
1.5%
1/65 • Number of events 1 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Injury, poisoning and procedural complications
Subdural Haematoma
|
1.5%
1/65 • Number of events 1 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Investigations
Csf Bacteria Identified
|
1.5%
1/65 • Number of events 1 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
Other adverse events
| Measure |
Marqibo
n=65 participants at risk
Eligible subjects received study drug at 2.25 mg/m2 intravenously via peripheral or central venous access over 60 minutes (± 10 minutes).
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
53.8%
35/65 • Number of events 35 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Gastrointestinal disorders
Constipation
|
52.3%
34/65 • Number of events 34 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Gastrointestinal disorders
Diarrhoea
|
33.8%
22/65 • Number of events 22 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Gastrointestinal disorders
Vomiting
|
26.2%
17/65 • Number of events 17 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Gastrointestinal disorders
Abdominal pain
|
20.0%
13/65 • Number of events 13 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Gastrointestinal disorders
Stomatitis
|
13.8%
9/65 • Number of events 9 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Gastrointestinal disorders
Abdominal distension
|
10.8%
7/65 • Number of events 7 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Gastrointestinal disorders
Gingival bleeding
|
9.2%
6/65 • Number of events 6 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Gastrointestinal disorders
Dry mouth
|
6.2%
4/65 • Number of events 4 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Gastrointestinal disorders
Dysphagia
|
6.2%
4/65 • Number of events 4 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Gastrointestinal disorders
Flatulence
|
6.2%
4/65 • Number of events 4 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
General disorders
Pyrexia
|
38.5%
25/65 • Number of events 25 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
General disorders
Fatigue
|
29.2%
19/65 • Number of events 19 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
General disorders
Asthenia
|
23.1%
15/65 • Number of events 15 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
General disorders
Pain
|
23.1%
15/65 • Number of events 15 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
General disorders
Oedema, peripheral
|
15.4%
10/65 • Number of events 10 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
General disorders
Chills
|
12.3%
8/65 • Number of events 8 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
General disorders
Chest pain
|
10.8%
7/65 • Number of events 7 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Nervous system disorders
Neuropathy, peripheral
|
30.8%
20/65 • Number of events 20 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Nervous system disorders
Headache
|
26.2%
17/65 • Number of events 17 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Nervous system disorders
Hypoaesthesia
|
24.6%
16/65 • Number of events 16 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Nervous system disorders
Paraesthesia
|
21.5%
14/65 • Number of events 14 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Nervous system disorders
Dizziness
|
15.4%
10/65 • Number of events 10 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Nervous system disorders
Areflexia
|
9.2%
6/65 • Number of events 6 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Nervous system disorders
Hyporeflexia
|
7.7%
5/65 • Number of events 5 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Nervous system disorders
Cranial neuropathy
|
6.2%
4/65 • Number of events 4 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Nervous system disorders
Facial neuralgia
|
6.2%
4/65 • Number of events 4 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Nervous system disorders
Neuralgia
|
6.2%
4/65 • Number of events 4 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
36.9%
24/65 • Number of events 24 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Blood and lymphatic system disorders
Anaemia
|
26.2%
17/65 • Number of events 17 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Blood and lymphatic system disorders
Neutropenia
|
23.1%
15/65 • Number of events 15 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
23.1%
15/65 • Number of events 15 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Blood and lymphatic system disorders
Leukopenia
|
7.7%
5/65 • Number of events 5 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
36.9%
24/65 • Number of events 24 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
26.2%
17/65 • Number of events 17 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
13.8%
9/65 • Number of events 9 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
10.8%
7/65 • Number of events 7 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
10.8%
7/65 • Number of events 7 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
9.2%
6/65 • Number of events 6 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Metabolism and nutrition disorders
Dehydration
|
7.7%
5/65 • Number of events 5 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
7.7%
5/65 • Number of events 5 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
7.7%
5/65 • Number of events 5 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Metabolism and nutrition disorders
Cachexia
|
6.2%
4/65 • Number of events 4 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.0%
13/65 • Number of events 13 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
18.5%
12/65 • Number of events 12 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
13.8%
9/65 • Number of events 9 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.3%
8/65 • Number of events 8 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
9.2%
6/65 • Number of events 6 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.7%
5/65 • Number of events 5 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
24.6%
16/65 • Number of events 16 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
15.4%
10/65 • Number of events 10 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
15.4%
10/65 • Number of events 10 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.8%
7/65 • Number of events 7 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.2%
4/65 • Number of events 4 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Investigations
Weight decreased
|
15.4%
10/65 • Number of events 10 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Investigations
Alanine aminotransferase increased
|
10.8%
7/65 • Number of events 7 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Investigations
Aspartate aminotransferase increased
|
10.8%
7/65 • Number of events 7 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Investigations
Blood lactate dehydrogenase increased
|
10.8%
7/65 • Number of events 7 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Investigations
Blood alkaline phosphatase increased
|
6.2%
4/65 • Number of events 4 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Psychiatric disorders
Insomnia
|
24.6%
16/65 • Number of events 16 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Psychiatric disorders
Confusional state
|
15.4%
10/65 • Number of events 10 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Psychiatric disorders
Anxiety
|
9.2%
6/65 • Number of events 6 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Psychiatric disorders
Depression
|
7.7%
5/65 • Number of events 5 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Psychiatric disorders
Agitation
|
6.2%
4/65 • Number of events 4 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Infections and infestations
Pneumonia
|
13.8%
9/65 • Number of events 9 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Infections and infestations
Oral candidiasis
|
6.2%
4/65 • Number of events 4 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Infections and infestations
Septic shock
|
6.2%
4/65 • Number of events 4 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Infections and infestations
Urinary tract infection
|
6.2%
4/65 • Number of events 4 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.3%
8/65 • Number of events 8 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
6.2%
4/65 • Number of events 4 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
6.2%
4/65 • Number of events 4 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Vascular disorders
Hypertension
|
16.9%
11/65 • Number of events 11 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Vascular disorders
Hypotension
|
15.4%
10/65 • Number of events 10 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Vascular disorders
Orthostatic hypotension
|
6.2%
4/65 • Number of events 4 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Cardiac disorders
Tachycardia
|
16.9%
11/65 • Number of events 11 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Renal and urinary disorders
Urinary incontinence
|
6.2%
4/65 • Number of events 4 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukemia
|
13.8%
9/65 • Number of events 9 • From date of first dose of study drug until 30 days after last Marqibo dose (+ 5 days)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60