Trial Outcomes & Findings for Homoharringtonine With Oral Gleevec in Chronic, Accelerated and Blast Phase Chronic Myeloid Leukemia (CML) (NCT NCT00114959)
NCT ID: NCT00114959
Last Updated: 2015-01-15
Results Overview
Participants in accelerated or blast phase who converted to at least CML-chronic phase. CML in accelerated phase meets one or more of the following criteria: \>=15% - \<30% blasts in peripheral blood or bone marrow, \>=30% blasts + promyelocytes in peripheral blood or bone marrow, \>=20% basophils in peripheral blood; platelet count \<100\*10\^9/L unrelated to therapy or clonal evolution. CML in blast phase have \>=30% blasts in the bone marrow or presence of extramedullary disease. Meaningful responses include (in descending order of health) * Complete Hematologic Remission (CHR) * Partial Hematologic Remission (PHR) * Hematologic Improvement (HI) * Partial Response (PR) * Return to Chronic Phase (RCP). A return to chronic phase involves the disappearance of blastic phase features and a return to chronic phase CML picture, i.e., peripheral blasts \<15%, peripheral blasts and promyelocytes \<30%, peripheral basophils \<20%, and platelets \>100\*10\^9/L.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
15 participants
Primary outcome timeframe
up to month 4
Results posted on
2015-01-15
Participant Flow
Participant milestones
| Measure |
Homoharringtonine + Imatinib Mesylate
Participants are administered homoharringtonine (omacetaxine) 2.5 mg/m\^2 by continuous 24-hour intravenous infusion daily on Days 1-5 of each 4 week treatment cycle, and imatinib mesylate (Gleevec) by mouth with a daily dose of 400 mg for participants in the chronic phase of chronic myeloid leukemia (CML) or 600 mg for participants in the accelerated or blast phase of CML.
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
Homoharringtonine + Imatinib Mesylate
Participants are administered homoharringtonine (omacetaxine) 2.5 mg/m\^2 by continuous 24-hour intravenous infusion daily on Days 1-5 of each 4 week treatment cycle, and imatinib mesylate (Gleevec) by mouth with a daily dose of 400 mg for participants in the chronic phase of chronic myeloid leukemia (CML) or 600 mg for participants in the accelerated or blast phase of CML.
|
|---|---|
|
Overall Study
Lack of Efficacy
|
6
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Death
|
1
|
Baseline Characteristics
Homoharringtonine With Oral Gleevec in Chronic, Accelerated and Blast Phase Chronic Myeloid Leukemia (CML)
Baseline characteristics by cohort
| Measure |
Homoharringtonine + Imatinib Mesylate
n=15 Participants
Participants are administered homoharringtonine (omacetaxine) 2.5 mg/m\^2 by continuous 24-hour intravenous infusion daily on Days 1-5 of each 4 week treatment cycle, and imatinib mesylate (Gleevec) by mouth with a daily dose of 400 mg for participants in the chronic phase of chronic myeloid leukemia (CML) or 600 mg for participants in the accelerated or blast phase of CML.
|
|---|---|
|
Age, Continuous
|
55 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
4 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
10 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to month 4Population: No participants were analyzed since the study was intended to follow a Simon two stage design to test 18 participants in each stratum (chronic, accelerated and blast phases) for efficacy. Enrollment was insufficient.
Participants in accelerated or blast phase who converted to at least CML-chronic phase. CML in accelerated phase meets one or more of the following criteria: \>=15% - \<30% blasts in peripheral blood or bone marrow, \>=30% blasts + promyelocytes in peripheral blood or bone marrow, \>=20% basophils in peripheral blood; platelet count \<100\*10\^9/L unrelated to therapy or clonal evolution. CML in blast phase have \>=30% blasts in the bone marrow or presence of extramedullary disease. Meaningful responses include (in descending order of health) * Complete Hematologic Remission (CHR) * Partial Hematologic Remission (PHR) * Hematologic Improvement (HI) * Partial Response (PR) * Return to Chronic Phase (RCP). A return to chronic phase involves the disappearance of blastic phase features and a return to chronic phase CML picture, i.e., peripheral blasts \<15%, peripheral blasts and promyelocytes \<30%, peripheral basophils \<20%, and platelets \>100\*10\^9/L.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: up to month 4Population: No participants were analyzed since the study was intended to follow a Simon two stage design to test 18 participants in each stratum (chronic, accelerated and blast phases) for efficacy. Enrollment was insufficient.
Participants who are not in complete hematologic remission (CHR) at study start must achieve at least a CHR, and participants who are in CHR at onset must demonstrate an improvement in their cytogenetics. A Complete Hematologic Remission (CHR) involves normalization of the bone marrow (less than 5% blasts) and peripheral blood with white blood cells \< 10\*10\^9/L, absolute neutrophil count \>=1\*10\^9/L, platelets \>=100\*10\^9/L and no peripheral blasts, promyelocytes or myelocytes. This is in addition to disappearance of all signs and symptoms of the disease.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: up to 3 yearsPopulation: All treated participants
Summary of participants who had adverse events (AEs), who discontinued treatment due to the AE, who had serious adverse events (SAEs), and who had SAEs that were related to treatments. A serious adverse event is one that at any dose of the study drug or at any time during the period of observation: * Results in death; * Is life threatening; * Requires inpatient hospitalization or prolongation of existing hospitalization; * Results in persistent or significant disability/incapacity; * Is a congenital anomaly/birth defect; * Is medically important. The Investigator assessed each AE for potential causal relationship between the event and study drug. An investigator assessment of possibly, probably or unknown relation is considered related.
Outcome measures
| Measure |
Homoharringtonine + Imatinib Mesylate
n=15 Participants
Participants are administered homoharringtonine (omacetaxine) 2.5 mg/m\^2 by continuous 24-hour intravenous infusion daily on Days 1-5 of each 4 week treatment cycle, and imatinib mesylate (Gleevec) by mouth with a daily dose of 400 mg for participants in the chronic phase of chronic myeloid leukemia (CML) or 600 mg for participants in the accelerated or blast phase of CML.
|
|---|---|
|
Number of Participants With Adverse Experiences (AEs)
AEs
|
15 participants
|
|
Number of Participants With Adverse Experiences (AEs)
Discontinued due to AE
|
2 participants
|
|
Number of Participants With Adverse Experiences (AEs)
Serious AEs
|
12 participants
|
|
Number of Participants With Adverse Experiences (AEs)
SAEs considered related
|
7 participants
|
SECONDARY outcome
Timeframe: up to month 4Population: No participants were analyzed since the study was intended to follow a Simon two stage design to test 18 participants in each stratum (chronic, accelerated and blast phases) for efficacy. Enrollment was insufficient.
Complete hematologic remission was further classified according to the suppression of the Philadelphia chromosome (Ph) as: No cytogenetic response - Ph positive 100% Minimal cytogenetic response - Ph positive 35-90% Partial cytogenetic response - Ph positive 1-34% Complete cytogenetic response - Ph positive 0%
Outcome measures
Outcome data not reported
Adverse Events
Homoharringtonine + Imatinib Mesylate
Serious events: 12 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Homoharringtonine + Imatinib Mesylate
n=15 participants at risk
Participants are administered homoharringtonine (omacetaxine) 2.5 mg/m\^2 by continuous 24-hour intravenous infusion daily on Days 1-5 of each 4 week treatment cycle, and imatinib mesylate (Gleevec) by mouth with a daily dose of 400 mg for participants in the chronic phase of chronic myeloid leukemia (CML) or 600 mg for participants in the accelerated or blast phase of CML.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Blood and lymphatic system disorders
Neutropenic fever
|
20.0%
3/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Renal and urinary disorders
Renal failure
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Musculoskeletal and connective tissue disorders
Pain, upper extremities
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
General disorders
Fever
|
13.3%
2/15 • Day 1 up to 3 years (30 days past last dose)
|
|
General disorders
Infection
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Gastrointestinal disorders
Gastrointestinal bleeding
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Gastrointestinal disorders
Hemorrhage, gastrointestinal
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Injury, poisoning and procedural complications
Fatal car accident
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
General disorders
Weakness
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Vascular disorders
Cerebral vascular event (fatal)
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Vascular disorders
Hypotension
|
13.3%
2/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Renal and urinary disorders
Acute renal failure
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Cardiac disorders
Atrial fibrillation
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Vascular disorders
Intra-cranial hemorrhage
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
General disorders
Sudden death
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Investigations
Leukocytosis
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Nervous system disorders
Dizziness
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
General disorders
Death
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Musculoskeletal and connective tissue disorders
Pain, low back
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
Other adverse events
| Measure |
Homoharringtonine + Imatinib Mesylate
n=15 participants at risk
Participants are administered homoharringtonine (omacetaxine) 2.5 mg/m\^2 by continuous 24-hour intravenous infusion daily on Days 1-5 of each 4 week treatment cycle, and imatinib mesylate (Gleevec) by mouth with a daily dose of 400 mg for participants in the chronic phase of chronic myeloid leukemia (CML) or 600 mg for participants in the accelerated or blast phase of CML.
|
|---|---|
|
General disorders
Allergies
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
General disorders
Bacteremia
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
General disorders
Bleeding at CVC site
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
General disorders
Bleeding at PICC line insertion site
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
General disorders
Bleeding at port site
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
General disorders
Bruising
|
13.3%
2/15 • Day 1 up to 3 years (30 days past last dose)
|
|
General disorders
Chills
|
13.3%
2/15 • Day 1 up to 3 years (30 days past last dose)
|
|
General disorders
Chills, intermittent
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
General disorders
Citrobacter freundii positive
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
General disorders
Fatigue
|
46.7%
7/15 • Day 1 up to 3 years (30 days past last dose)
|
|
General disorders
Mild fatigue
|
26.7%
4/15 • Day 1 up to 3 years (30 days past last dose)
|
|
General disorders
Severe fatigue
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
General disorders
Fever
|
13.3%
2/15 • Day 1 up to 3 years (30 days past last dose)
|
|
General disorders
Fibromyalgia syndrome
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Gastrointestinal disorders
Fluid retention
|
13.3%
2/15 • Day 1 up to 3 years (30 days past last dose)
|
|
General disorders
Generalized achiness
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Infections and infestations
Infection, Staphylococcus aureus
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
General disorders
Intermittent fatigue
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
General disorders
Intermittent fever
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
General disorders
Mild fever
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
General disorders
Pain, left flank
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
General disorders
Pain, left upper quadrant
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
General disorders
Pain, right hip
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
General disorders
Pallor
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Infections and infestations
Pseudomonas aeruginosa
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
General disorders
Runny nose
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
General disorders
Weakness
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
General disorders
Mildly weak
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
General disorders
Edema
|
13.3%
2/15 • Day 1 up to 3 years (30 days past last dose)
|
|
General disorders
Edema, intermittent
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
General disorders
Edema, pedal
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
General disorders
Edema, ankle
|
13.3%
2/15 • Day 1 up to 3 years (30 days past last dose)
|
|
General disorders
Edema, bilateral
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
General disorders
Edema, bilateral pedal
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
General disorders
Edema, bilateral legs + 2 pitting
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
General disorders
Edema, bilateral lower extremity
|
20.0%
3/15 • Day 1 up to 3 years (30 days past last dose)
|
|
General disorders
Edema, lower extremity
|
13.3%
2/15 • Day 1 up to 3 years (30 days past last dose)
|
|
General disorders
Edema, peripheral
|
13.3%
2/15 • Day 1 up to 3 years (30 days past last dose)
|
|
General disorders
Edema, Intermittent trace peripheral
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Investigations
Hemoglobin decreased
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Investigations
Leukocytosis
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
General disorders
Palpitations
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
General disorders
Periorbital edema
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
General disorders
Right Arm Swelling
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
General disorders
Right side face swelling
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Investigations
Severe thrombocytopenia
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
General disorders
Swelling, hands and feet
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
General disorders
Swelling, right arm
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Skin and subcutaneous tissue disorders
Acanthosis nigricans
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Skin and subcutaneous tissue disorders
Bruising skin
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Skin and subcutaneous tissue disorders
Erythema, left foot
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Skin and subcutaneous tissue disorders
Erythema, tonsils
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Skin and subcutaneous tissue disorders
Hypopigmentation facial
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Skin and subcutaneous tissue disorders
Itching due to transfusion
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Skin and subcutaneous tissue disorders
Itching impaired
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Skin and subcutaneous tissue disorders
Generalized skin itching
|
13.3%
2/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Skin and subcutaneous tissue disorders
Itchy ears
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Skin and subcutaneous tissue disorders
Keratoderma, pedal
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Skin and subcutaneous tissue disorders
Pedal calluses
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Skin and subcutaneous tissue disorders
Mild rash
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Skin and subcutaneous tissue disorders
Mouth sores
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Skin and subcutaneous tissue disorders
Mouth sores, intermittent
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Skin and subcutaneous tissue disorders
Mouth ulcerations
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Skin and subcutaneous tissue disorders
Oral white patches
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Skin and subcutaneous tissue disorders
Peeling skin, groin
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Skin and subcutaneous tissue disorders
Plantar surface skin sensitive
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Skin and subcutaneous tissue disorders
Painful, red, swollen rash
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Skin and subcutaneous tissue disorders
Rash abdomen
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Skin and subcutaneous tissue disorders
Rash, macular / facial
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Skin and subcutaneous tissue disorders
Seborrheic keratosis, upper extremity
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Skin and subcutaneous tissue disorders
Skin nodule
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Skin and subcutaneous tissue disorders
Swelling, face
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Skin and subcutaneous tissue disorders
Tinea
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Skin and subcutaneous tissue disorders
Punctate lesion right foot dorsom
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Skin and subcutaneous tissue disorders
Vesicular lesions, right buttock
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Skin and subcutaneous tissue disorders
Yeast infection, buttock
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Gastrointestinal disorders
Abdominal bloating
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Gastrointestinal disorders
Abdominal discomfort intermittent
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Gastrointestinal disorders
Abdominal pain
|
20.0%
3/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Gastrointestinal disorders
Abdominal pain, interrmittent left sided
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Gastrointestinal disorders
Anorexia
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Gastrointestinal disorders
Colon polyps
|
13.3%
2/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Gastrointestinal disorders
Constipation
|
13.3%
2/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Gastrointestinal disorders
Constipation, intermittent
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Gastrointestinal disorders
Diarrhea
|
46.7%
7/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Gastrointestinal disorders
Dry heaves
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Gastrointestinal disorders
Flatus
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Gastrointestinal disorders
Gastritis
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Gastrointestinal disorders
GERD
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Gastrointestinal disorders
Hemorrhoids
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Gastrointestinal disorders
Hepatic Dysfunction
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Gastrointestinal disorders
Indigestion
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Gastrointestinal disorders
Lack of appetite
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Gastrointestinal disorders
Poor appetite
|
13.3%
2/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Gastrointestinal disorders
Suppressed appetite
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Gastrointestinal disorders
Loose stools
|
20.0%
3/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Gastrointestinal disorders
Melena
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Gastrointestinal disorders
Mild nausea
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Gastrointestinal disorders
Nausea
|
53.3%
8/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Gastrointestinal disorders
Nausea, intermittent
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Gastrointestinal disorders
Pandiverticulosis
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Gastrointestinal disorders
Rectal bleeding
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Gastrointestinal disorders
Renal failure
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Gastrointestinal disorders
Stomach discomfort
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Gastrointestinal disorders
Upset stomach
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Gastrointestinal disorders
Vomiting
|
73.3%
11/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Gastrointestinal disorders
Vomiting, occasional
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Blood and lymphatic system disorders
Anemia
|
60.0%
9/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Blood and lymphatic system disorders
Bruising
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Blood and lymphatic system disorders
Abdominal bruising, secondary to SC injections
|
13.3%
2/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Blood and lymphatic system disorders
Decreased prothrombinemia
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Blood and lymphatic system disorders
Ecchymoses, mouth and arms
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Investigations
Elevated BUN
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Investigations
Elevated PTT
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Investigations
Decreased hemaglobin
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Blood and lymphatic system disorders
Hematoma
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Blood and lymphatic system disorders
Hepatitis A
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Blood and lymphatic system disorders
Hypertriglyceridemia
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Blood and lymphatic system disorders
Intermittent anemia
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Blood and lymphatic system disorders
Myelosuppression
|
33.3%
5/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Blood and lymphatic system disorders
Neutropenia
|
53.3%
8/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Blood and lymphatic system disorders
Neutropenic fever
|
13.3%
2/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Blood and lymphatic system disorders
Nosebleed
|
13.3%
2/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Blood and lymphatic system disorders
Pancytopenia
|
20.0%
3/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Blood and lymphatic system disorders
Petechiae
|
13.3%
2/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Blood and lymphatic system disorders
Petechiae abdomen
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Blood and lymphatic system disorders
Petechiae head, arms, neck, oral
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Blood and lymphatic system disorders
Petechiae thigh
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
53.3%
8/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Blood and lymphatic system disorders
Thrombocytopenia, intermittent
|
33.3%
5/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
13.3%
2/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Metabolism and nutrition disorders
Dehydration
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Investigations
Elevated creatinine
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Investigations
Elevated LDH
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Metabolism and nutrition disorders
Goiter, nodular
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Metabolism and nutrition disorders
Hot flashes
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
13.3%
2/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Metabolism and nutrition disorders
Hypokalemia
|
26.7%
4/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
26.7%
4/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Metabolism and nutrition disorders
Hypomagnesium
|
13.3%
2/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Metabolism and nutrition disorders
Uricemia
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Musculoskeletal and connective tissue disorders
Aching all over
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Musculoskeletal and connective tissue disorders
Bilateral upper pain - extremities
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Musculoskeletal and connective tissue disorders
Cellulitis, left arm
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Musculoskeletal and connective tissue disorders
Chest pain
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Musculoskeletal and connective tissue disorders
Chest pressure
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Musculoskeletal and connective tissue disorders
Cramps right leg, right arm
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Musculoskeletal and connective tissue disorders
Cramps, muscle
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Musculoskeletal and connective tissue disorders
Cramps, neck
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Musculoskeletal and connective tissue disorders
Cramps, pedal muscle bilateral
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Musculoskeletal and connective tissue disorders
Dental abscesses
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Musculoskeletal and connective tissue disorders
Diffused bone pain
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Musculoskeletal and connective tissue disorders
Left hip and leg pain, secondary to bone marrow aspiration
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Musculoskeletal and connective tissue disorders
Leg muscle soreness
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Musculoskeletal and connective tissue disorders
Leg trembling on standing
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Musculoskeletal and connective tissue disorders
Pain, bilateral knee
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Musculoskeletal and connective tissue disorders
Pain, bilateral shoulder
|
13.3%
2/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Musculoskeletal and connective tissue disorders
Pain, bone
|
13.3%
2/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Musculoskeletal and connective tissue disorders
Pain, knee
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Musculoskeletal and connective tissue disorders
Pain, left knee
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Musculoskeletal and connective tissue disorders
Pain, left great toe
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Musculoskeletal and connective tissue disorders
Pain, low back
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Musculoskeletal and connective tissue disorders
Pain, muscle
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Musculoskeletal and connective tissue disorders
Pain, back and shoulder
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Musculoskeletal and connective tissue disorders
Pain, neck
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Musculoskeletal and connective tissue disorders
Pain, upper extremities
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Musculoskeletal and connective tissue disorders
Teeth sensitivity
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Musculoskeletal and connective tissue disorders
Tooth pain
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Nervous system disorders
Anxiety
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Nervous system disorders
Bad dreams
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Nervous system disorders
Confusion
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Nervous system disorders
Mild confusion
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Nervous system disorders
Dizziness
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Nervous system disorders
Dizziness, fentanyl
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Nervous system disorders
Dysphagia
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Nervous system disorders
Headache
|
40.0%
6/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Nervous system disorders
Headache/migraine, intermittent right side
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Nervous system disorders
Headache, sinus
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Nervous system disorders
Insomnia
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Nervous system disorders
Light headed
|
13.3%
2/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Nervous system disorders
Neuropathy, bipedal
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Nervous system disorders
Neuropathy, hands and feet
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Nervous system disorders
Peripheral neuropathy, secondary to diabetes
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Nervous system disorders
Night sweats
|
13.3%
2/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Nervous system disorders
Numbness, toe
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Nervous system disorders
Numbness/tingling in extremities
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Nervous system disorders
Syncope
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
5/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.0%
3/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Respiratory, thoracic and mediastinal disorders
Klebsiella pneumonia
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory infection
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Respiratory, thoracic and mediastinal disorders
Short of breath
|
13.3%
2/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath on exertion
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
13.3%
2/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion intermittent, secondary to allergies
|
13.3%
2/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
13.3%
2/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
13.3%
2/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection nasal allergies
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
General disorders
Bleeding gums
|
26.7%
4/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Eye disorders
Conjunctival melanosis
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Surgical and medical procedures
Dental extraction
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
General disorders
Gum soreness
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
General disorders
Gum tenderness
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Eye disorders
Itchy eyes
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
General disorders
Lip bleeding
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
General disorders
Loss of taste
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
General disorders
Malodor, secondary to right groin hematoma
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
General disorders
Mucositis
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
General disorders
Oral ulcer
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
General disorders
Right Ear Pressure
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
General disorders
Sinus drainage
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Infections and infestations
Staph infection right nostril
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
General disorders
Throat pain
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Ear and labyrinth disorders
Worsening otitis media
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Renal and urinary disorders
Dark urine
|
6.7%
1/15 • Day 1 up to 3 years (30 days past last dose)
|
|
Renal and urinary disorders
Urinary tract infection
|
20.0%
3/15 • Day 1 up to 3 years (30 days past last dose)
|
Additional Information
Director, Clinical Research
Teva Branded Pharmaceutical Products, R&D Inc.
Phone: 215-591-3000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.
- Publication restrictions are in place
Restriction type: OTHER