Trial Outcomes & Findings for Campath-1H and EPOCH to Treat Non-Hodgkin's T- and NK-Cell Lymphomas (NCT NCT00069238)
NCT ID: NCT00069238
Last Updated: 2022-02-24
Results Overview
MTD was achieved by increasing doses of Alemtuzumab on three cohorts. Cohort 1 received 30mg of Alemtuzumab, cohort 2 received 60mg of Alemtuzumab, and cohort 3 received 90mg of Alemtuzumab intravenously up to 2 cycles. The MTD reflects the highest dose of Alemtuzumab in which no more than 1 of 6 participants entered at a specific dose level experienced a dose limiting toxicity (DLT).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
31 participants
Primary outcome timeframe
up to 2 cycles of therapy, approximately 42 days
Results posted on
2022-02-24
Participant Flow
Participant milestones
| Measure |
Alemtuzumab 30 mg
Alemtuzumab (Campath) 30mg intravenous (IV) on day 1 of therapy, followed by etoposide (50mg/m(2) day continuous intravenous (CIV) day 1-4 (96 hours)), prednisone (60mg/m(2) day by mouth (PO) day 0-5), vincristine (0.4mg/m(2) day continuous intravenous (CIV) day 1-4 (96 hours)), cyclophosphamide (750mg/m(2) day intravenous day 5), doxorubicin (10mg/m(2) day continuous intravenous (CIV) day 1-4 (96 hours)), (EPOCH) days 1-5 every 3 weeks for up to 6 cycles.
|
Alemtuzumab 60 mg
Alemtuzumab (Campath) 60mg intravenous (IV) on day 1 of therapy, followed by etoposide (50mg/m(2) day continuous intravenous (CIV) day 1-4 (96 hours)), prednisone (60mg/m(2) day by mouth (PO) day 0-5), vincristine (0.4mg/m(2) day continuous intravenous (CIV) day 1-4 (96 hours)), cyclophosphamide (750mg/m(2) day intravenous day 5), doxorubicin (10mg/m(2) day continuous intravenous (CIV) day 1-4 (96 hours)), (EPOCH) days 1-5 every 3 weeks for up to 6 cycles.
|
Alemtuzumab 90 mg
Alemtuzumab (Campath) 90mg intravenous (IV) on day 1 of therapy, followed by etoposide (50mg/m(2) day continuous intravenous (CIV) day 1-4 (96 hours)), prednisone (60mg/m(2) day by mouth (PO) day 0-5), vincristine (0.4mg/m(2) day continuous intravenous (CIV) day 1-4 (96 hours)), cyclophosphamide (750mg/m(2) day intravenous day 5), doxorubicin (10mg/m(2) day continuous intravenous (CIV) day 1-4 (96 hours)), (EPOCH) days 1-5 every 3 weeks for up to 6 cycles.
|
|---|---|---|---|
|
Cohort 1 - Dose Level 1 (Weeks 1 - 18)
STARTED
|
25
|
0
|
0
|
|
Cohort 1 - Dose Level 1 (Weeks 1 - 18)
COMPLETED
|
16
|
0
|
0
|
|
Cohort 1 - Dose Level 1 (Weeks 1 - 18)
NOT COMPLETED
|
9
|
0
|
0
|
|
Cohort 2 - Dose Level 2 (Weeks 1-18)
STARTED
|
0
|
3
|
0
|
|
Cohort 2 - Dose Level 2 (Weeks 1-18)
COMPLETED
|
0
|
1
|
0
|
|
Cohort 2 - Dose Level 2 (Weeks 1-18)
NOT COMPLETED
|
0
|
2
|
0
|
|
Cohort 3 - Dose Level 3 (Weeks 1-18)
STARTED
|
0
|
0
|
3
|
|
Cohort 3 - Dose Level 3 (Weeks 1-18)
COMPLETED
|
0
|
0
|
1
|
|
Cohort 3 - Dose Level 3 (Weeks 1-18)
NOT COMPLETED
|
0
|
0
|
2
|
Reasons for withdrawal
| Measure |
Alemtuzumab 30 mg
Alemtuzumab (Campath) 30mg intravenous (IV) on day 1 of therapy, followed by etoposide (50mg/m(2) day continuous intravenous (CIV) day 1-4 (96 hours)), prednisone (60mg/m(2) day by mouth (PO) day 0-5), vincristine (0.4mg/m(2) day continuous intravenous (CIV) day 1-4 (96 hours)), cyclophosphamide (750mg/m(2) day intravenous day 5), doxorubicin (10mg/m(2) day continuous intravenous (CIV) day 1-4 (96 hours)), (EPOCH) days 1-5 every 3 weeks for up to 6 cycles.
|
Alemtuzumab 60 mg
Alemtuzumab (Campath) 60mg intravenous (IV) on day 1 of therapy, followed by etoposide (50mg/m(2) day continuous intravenous (CIV) day 1-4 (96 hours)), prednisone (60mg/m(2) day by mouth (PO) day 0-5), vincristine (0.4mg/m(2) day continuous intravenous (CIV) day 1-4 (96 hours)), cyclophosphamide (750mg/m(2) day intravenous day 5), doxorubicin (10mg/m(2) day continuous intravenous (CIV) day 1-4 (96 hours)), (EPOCH) days 1-5 every 3 weeks for up to 6 cycles.
|
Alemtuzumab 90 mg
Alemtuzumab (Campath) 90mg intravenous (IV) on day 1 of therapy, followed by etoposide (50mg/m(2) day continuous intravenous (CIV) day 1-4 (96 hours)), prednisone (60mg/m(2) day by mouth (PO) day 0-5), vincristine (0.4mg/m(2) day continuous intravenous (CIV) day 1-4 (96 hours)), cyclophosphamide (750mg/m(2) day intravenous day 5), doxorubicin (10mg/m(2) day continuous intravenous (CIV) day 1-4 (96 hours)), (EPOCH) days 1-5 every 3 weeks for up to 6 cycles.
|
|---|---|---|---|
|
Cohort 1 - Dose Level 1 (Weeks 1 - 18)
Toxicity
|
9
|
0
|
0
|
|
Cohort 2 - Dose Level 2 (Weeks 1-18)
Toxicity
|
0
|
2
|
0
|
|
Cohort 3 - Dose Level 3 (Weeks 1-18)
Toxicity
|
0
|
0
|
2
|
Baseline Characteristics
Campath-1H and EPOCH to Treat Non-Hodgkin's T- and NK-Cell Lymphomas
Baseline characteristics by cohort
| Measure |
All Participants
n=31 Participants
All participants who received at least one dose of Alemtuzumab (Campath) 30mg, 60mg, or 90mg on day 1 of therapy followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin (EPOCH) chemotherapy intravenously every 3 weeks for up to 6 cycles.
|
|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=93 Participants
|
|
Age, Continuous
|
49.52 years
STANDARD_DEVIATION 15.5 • n=93 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
31 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: up to 2 cycles of therapy, approximately 42 daysMTD was achieved by increasing doses of Alemtuzumab on three cohorts. Cohort 1 received 30mg of Alemtuzumab, cohort 2 received 60mg of Alemtuzumab, and cohort 3 received 90mg of Alemtuzumab intravenously up to 2 cycles. The MTD reflects the highest dose of Alemtuzumab in which no more than 1 of 6 participants entered at a specific dose level experienced a dose limiting toxicity (DLT).
Outcome measures
| Measure |
All Participants
n=31 Participants
All participants who received at least one dose of Alemtuzumab (Campath) 30mg, 60mg, or 90mg on day 1 of therapy followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin (EPOCH) chemotherapy intravenously every 3 weeks for up to 6 cycles.
|
|---|---|
|
Maximum Tolerated Dose (MTD) of Alemtuzumab
|
30 mg
|
PRIMARY outcome
Timeframe: 67 months and 9 daysHere is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.
Outcome measures
| Measure |
All Participants
n=31 Participants
All participants who received at least one dose of Alemtuzumab (Campath) 30mg, 60mg, or 90mg on day 1 of therapy followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin (EPOCH) chemotherapy intravenously every 3 weeks for up to 6 cycles.
|
|---|---|
|
Number of Participants With Adverse Events
|
31 Participants
|
SECONDARY outcome
Timeframe: From date of onstudy until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 67 months and 9 days.Response was measured by the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas. Complete remission (CR) is complete disappearance of all detectable clinical and radiographic evidence of disease. Complete response unconfirmed (Cru)is as per complete remission criterion except that if a residual node is greater than 1.5cm, it must have decreased by greater than 75% in the sum of the products of the perpendicular diameters (SPD). Partial response (PR) is ≥50% decrease in the SPD of 6 largest dominant nodes or nodal masses. Progressive disease (PD) is ≥50% increase from the nadir in the SPD of any previously identified abnormal node for PRS or non-responders. Stable disease (SD) is less than a PR but not progressive disease.
Outcome measures
| Measure |
All Participants
n=31 Participants
All participants who received at least one dose of Alemtuzumab (Campath) 30mg, 60mg, or 90mg on day 1 of therapy followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin (EPOCH) chemotherapy intravenously every 3 weeks for up to 6 cycles.
|
|---|---|
|
Clinical Response
Progressive Disease
|
2 Participants
|
|
Clinical Response
Complete Response
|
17 Participants
|
|
Clinical Response
Complete Response Unconfirmed
|
0 Participants
|
|
Clinical Response
Partial Response
|
7 Participants
|
|
Clinical Response
Stable Disease
|
1 Participants
|
|
Clinical Response
Not Evaluable
|
4 Participants
|
Adverse Events
All Participants
Serious events: 23 serious events
Other events: 31 other events
Deaths: 23 deaths
Serious adverse events
| Measure |
All Participants
n=31 participants at risk
All participants who received at least one dose of Alemtuzumab (Campath) 30mg, 60mg, or 90mg on day 1 of therapy followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin (EPOCH) chemotherapy intravenously every 3 weeks for up to 6 cycles.
The adverse events are not reported per dose level because we normally look at all adverse events together irrespective of the dose level.
|
|---|---|
|
General disorders
DEATH:: Death related to the study
|
22.6%
7/31 • Number of events 7 • 67 months and 9 days
|
|
General disorders
DEATH:: Death due to progression
|
51.6%
16/31 • Number of events 16 • 67 months and 9 days
|
|
Blood and lymphatic system disorders
HEMORRHAGE/BLEEDING:: Hemorrhage, GI:: Upper GI Not otherwise specified (NOS)
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
Infections and infestations
INFECTION:: Febrile neutropenia
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
Infections and infestations
INFECTION:: Infection
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
Infections and infestations
INFECTION:: Infection (documented clinically or microbiologically)
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
Infections and infestations
INFECTION:: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
Infections and infestations
INFECTION:: Infection with unknown ANC:: Blood
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
Renal and urinary disorders
RENAL/GENITOURINARY:: Cystitis
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
Renal and urinary disorders
RENAL/GENITOURINARY:: Urinary frequency/urgency
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
Other adverse events
| Measure |
All Participants
n=31 participants at risk
All participants who received at least one dose of Alemtuzumab (Campath) 30mg, 60mg, or 90mg on day 1 of therapy followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin (EPOCH) chemotherapy intravenously every 3 weeks for up to 6 cycles.
The adverse events are not reported per dose level because we normally look at all adverse events together irrespective of the dose level.
|
|---|---|
|
Immune system disorders
ALLERGY/IMMUNOLOGY:: Allergic reaction/hypersensitivity (including drug fever)
|
22.6%
7/31 • Number of events 11 • 67 months and 9 days
|
|
Immune system disorders
ALLERGY/IMMUNOLOGY:: Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
|
29.0%
9/31 • Number of events 11 • 67 months and 9 days
|
|
Blood and lymphatic system disorders
AUDITORY/EAR:: Otitis, middle ear (non-infectious)
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
Ear and labyrinth disorders
AUDITORY/EAR:: Tinnitus
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
Blood and lymphatic system disorders
BLOOD/BONE MARROW:: Bone marrow cellularity
|
12.9%
4/31 • Number of events 4 • 67 months and 9 days
|
|
Blood and lymphatic system disorders
BLOOD/BONE MARROW:: Hemoglobin
|
93.5%
29/31 • Number of events 101 • 67 months and 9 days
|
|
Blood and lymphatic system disorders
BLOOD/BONE MARROW:: Leukocytes (total white blood count (WBC))
|
96.8%
30/31 • Number of events 121 • 67 months and 9 days
|
|
Blood and lymphatic system disorders
BLOOD/BONE MARROW:: Lymphopenia
|
96.8%
30/31 • Number of events 74 • 67 months and 9 days
|
|
Blood and lymphatic system disorders
BLOOD/BONE MARROW:: Neutrophils/granulocytes (ANC/AGC)
|
96.8%
30/31 • Number of events 116 • 67 months and 9 days
|
|
Cardiac disorders
BLOOD/BONE MARROW:: Platelets
|
90.3%
28/31 • Number of events 102 • 67 months and 9 days
|
|
Cardiac disorders
CARDIAC ARRHYTHMIA:: Palpitations
|
6.5%
2/31 • Number of events 2 • 67 months and 9 days
|
|
Blood and lymphatic system disorders
CARDIAC ARRHYTHMIA:: Supraventricular and nodal arrhythmia:: Sinus bradycardia
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
Cardiac disorders
CARDIAC ARRHYTHMIA:: Supraventricular and nodal arrhythmia:: Sinus tachycardia
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
General disorders
CARDIAC ARRHYTHMIA:: Supraventricular and nodal arrhythmia:: Supraventricular arrhythmia NOS
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
General disorders
CARDIAC ARRHYTHMIA:: Supraventricular and nodal arrhythmia:: Supraventricular tachycardia
|
6.5%
2/31 • Number of events 2 • 67 months and 9 days
|
|
Cardiac disorders
CARDIAC ARRHYTHMIA:: Vasovagal episode
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
Cardiac disorders
CARDIAC GENERAL:: Hypertension
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
Cardiac disorders
CARDIAC GENERAL:: Hypotension
|
29.0%
9/31 • Number of events 14 • 67 months and 9 days
|
|
Blood and lymphatic system disorders
COAGULATION:: PTT (Partial Thromboplastin Time)
|
12.9%
4/31 • Number of events 5 • 67 months and 9 days
|
|
General disorders
CONSTITUTIONAL SYMPTOMS:: Fatigue (asthenia, lethargy, malaise)
|
58.1%
18/31 • Number of events 33 • 67 months and 9 days
|
|
General disorders
CONSTITUTIONAL SYMPTOMS
|
35.5%
11/31 • Number of events 16 • 67 months and 9 days
|
|
General disorders
CONSTITUTIONAL SYMPTOMS:: Insomnia
|
16.1%
5/31 • Number of events 5 • 67 months and 9 days
|
|
General disorders
CONSTITUTIONAL SYMPTOMS:: Rigors/chills
|
29.0%
9/31 • Number of events 14 • 67 months and 9 days
|
|
General disorders
CONSTITUTIONAL SYMPTOMS:: Sweating (diaphoresis)
|
12.9%
4/31 • Number of events 4 • 67 months and 9 days
|
|
General disorders
CONSTITUTIONAL SYMPTOMS:: Weight loss
|
22.6%
7/31 • Number of events 8 • 67 months and 9 days
|
|
Skin and subcutaneous tissue disorders
DERMATOLOGY/SKIN:: Bruising (in absence of Grade 3 or 4 thrombocytopenia)
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
Skin and subcutaneous tissue disorders
DERMATOLOGY/SKIN:: Dermatology/Skin - Other (Specify, excoriation)
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
Skin and subcutaneous tissue disorders
DERMATOLOGY/SKIN:: Dry skin
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
Skin and subcutaneous tissue disorders
DERMATOLOGY/SKIN:: Flushing
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
Skin and subcutaneous tissue disorders
DERMATOLOGY/SKIN:: Hair loss/alopecia (scalp or body)
|
48.4%
15/31 • Number of events 15 • 67 months and 9 days
|
|
Skin and subcutaneous tissue disorders
DERMATOLOGY/SKIN:: Hyperpigmentation
|
6.5%
2/31 • Number of events 2 • 67 months and 9 days
|
|
Skin and subcutaneous tissue disorders
DERMATOLOGY/SKIN:: Injection site reaction/extravasation changes
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
Skin and subcutaneous tissue disorders
DERMATOLOGY/SKIN:: Nail changes
|
16.1%
5/31 • Number of events 5 • 67 months and 9 days
|
|
Skin and subcutaneous tissue disorders
DERMATOLOGY/SKIN:: Pruritus/itching
|
9.7%
3/31 • Number of events 4 • 67 months and 9 days
|
|
Skin and subcutaneous tissue disorders
DERMATOLOGY/SKIN:: Rash/desquamation
|
29.0%
9/31 • Number of events 12 • 67 months and 9 days
|
|
Skin and subcutaneous tissue disorders
DERMATOLOGY/SKIN:: Skin breakdown/decubitus ulcer
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
Gastrointestinal disorders
GASTROINTESTINAL:: Anorexia
|
35.5%
11/31 • Number of events 15 • 67 months and 9 days
|
|
Gastrointestinal disorders
GASTROINTESTINAL:: Constipation
|
38.7%
12/31 • Number of events 14 • 67 months and 9 days
|
|
Gastrointestinal disorders
GASTROINTESTINAL:: Dehydration
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
Gastrointestinal disorders
GASTROINTESTINAL:: Dental: teeth
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
Gastrointestinal disorders
GASTROINTESTINAL:: Diarrhea
|
45.2%
14/31 • Number of events 23 • 67 months and 9 days
|
|
Gastrointestinal disorders
GASTROINTESTINAL:: Dry mouth/salivary gland (xerostomia)
|
6.5%
2/31 • Number of events 2 • 67 months and 9 days
|
|
Gastrointestinal disorders
GASTROINTESTINAL:: Esophagitis
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
Gastrointestinal disorders
GASTROINTESTINAL:: Flatulence
|
6.5%
2/31 • Number of events 2 • 67 months and 9 days
|
|
Gastrointestinal disorders
GASTROINTESTINAL:: Gastritis (including bile reflux gastritis)
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
Gastrointestinal disorders
GASTROINTESTINAL:: Gastrointestinal - Other (Specify, duodenitis)
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
Gastrointestinal disorders
GASTROINTESTINAL:: Heartburn/dyspepsia
|
12.9%
4/31 • Number of events 4 • 67 months and 9 days
|
|
Gastrointestinal disorders
GASTROINTESTINAL:: Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation)
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
Gastrointestinal disorders
GASTROINTESTINAL:: Mucositis/stomatitis (clinical exam):: Oral cavity
|
64.5%
20/31 • Number of events 33 • 67 months and 9 days
|
|
Gastrointestinal disorders
GASTROINTESTINAL:: Mucositis/stomatitis (clinical exam):: Pharynx
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
Blood and lymphatic system disorders
GASTROINTESTINAL:: Mucositis/stomatitis (functional/symptomatic):: Esophagus
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
Gastrointestinal disorders
GASTROINTESTINAL:: Mucositis/stomatitis (functional/symptomatic):: Oral cavity
|
22.6%
7/31 • Number of events 8 • 67 months and 9 days
|
|
Gastrointestinal disorders
GASTROINTESTINAL:: Nausea
|
58.1%
18/31 • Number of events 38 • 67 months and 9 days
|
|
Gastrointestinal disorders
GASTROINTESTINAL:: Proctitis
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
Gastrointestinal disorders
GASTROINTESTINAL:: Taste alteration (dysgeusia)
|
12.9%
4/31 • Number of events 4 • 67 months and 9 days
|
|
Gastrointestinal disorders
GASTROINTESTINAL:: Typhlitis (cecal inflammation)
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
Gastrointestinal disorders
GASTROINTESTINAL:: Vomiting
|
41.9%
13/31 • Number of events 20 • 67 months and 9 days
|
|
Gastrointestinal disorders
HEMORRHAGE/BLEEDING:: Hemorrhage, GI:: Lower GI NOS
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
Gastrointestinal disorders
HEMORRHAGE/BLEEDING:: Hemorrhage, GI:: Oral cavity
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
Gastrointestinal disorders
HEMORRHAGE/BLEEDING:: Hemorrhage, GI:: Upper GI NOS
|
6.5%
2/31 • Number of events 2 • 67 months and 9 days
|
|
Renal and urinary disorders
HEMORRHAGE/BLEEDING:: Hemorrhage, GU:: Bladder
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
Renal and urinary disorders
HEMORRHAGE/BLEEDING:: Hemorrhage, GU:: Urinary NOS
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
Respiratory, thoracic and mediastinal disorders
HEMORRHAGE/BLEEDING:: Hemorrhage, pulmonary/upper respiratory:: Bronchopulmonary NOS
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
Metabolism and nutrition disorders
HEMORRHAGE/BLEEDING:: Hemorrhage, pulmonary/upper respiratory:: Nose
|
12.9%
4/31 • Number of events 5 • 67 months and 9 days
|
|
General disorders
HEMORRHAGE/BLEEDING:: Hemorrhage/Bleeding - Other (Specify, R. neck after picc line)
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
Skin and subcutaneous tissue disorders
HEMORRHAGE/BLEEDING:: Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
Metabolism and nutrition disorders
INFECTION:: Febrile neutropenia
|
51.6%
16/31 • Number of events 28 • 67 months and 9 days
|
|
Infections and infestations
INFECTION:: Infection(documented clinically or microbiologically) with Grade 3 or 4 neutrophils
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
Infections and infestations
INFECTION:: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils
|
3.2%
1/31 • Number of events 5 • 67 months and 9 days
|
|
Nervous system disorders
INFECTION:: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
Nervous system disorders
INFECTION:Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
Musculoskeletal and connective tissue disorders
INFECTION:: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils
|
6.5%
2/31 • Number of events 2 • 67 months and 9 days
|
|
Gastrointestinal disorders
INFECTION:: Infection - Other (Specify, BLOOD)
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
Infections and infestations
INFECTION:: Infection with normal ANC or Grade 1 or 2 neutrophils:: Blood
|
3.2%
1/31 • Number of events 3 • 67 months and 9 days
|
|
Infections and infestations
INFECTION:: Infection with normal ANC or Grade 1 or 2 neutrophils:: Oral cavity-gums (gingivitis)
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
Musculoskeletal and connective tissue disorders
INFECTION:: Infection with normal ANC or Grade 1 or 2 neutrophils:: Sinus
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
Infections and infestations
INFECTION:: Infection with normal ANC or Grade 1 or 2 neutrophils:: Skin (cellulitis)
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
Infections and infestations
INFECTION:: Infection with normal ANC or Grade 1 or 2 neutrophils:: Urinary tract NOS
|
12.9%
4/31 • Number of events 4 • 67 months and 9 days
|
|
Musculoskeletal and connective tissue disorders
INFECTION:: Infection with unknown ANC:: Blood
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
Infections and infestations
INFECTION:: Infection with unknown ANC:: Oral cavity-gums (gingivitis)
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
Infections and infestations
INFECTION:: Infection with unknown ANC:: Urinary tract NOS
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
Blood and lymphatic system disorders
LYMPHATICS:: Edema: head and neck
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
Blood and lymphatic system disorders
LYMPHATICS:: Edema: limb
|
12.9%
4/31 • Number of events 4 • 67 months and 9 days
|
|
Blood and lymphatic system disorders
LYMPHATICS:: Edema: trunk/genital
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
Metabolism and nutrition disorders
METABOLIC/LABORATORY:: ALT, SGPT (serum glutamic pyruvic transaminase)
|
45.2%
14/31 • Number of events 38 • 67 months and 9 days
|
|
Metabolism and nutrition disorders
METABOLIC/LABORATORY:: AST, SGOT(serum glutamic oxaloacetic transaminase)
|
45.2%
14/31 • Number of events 29 • 67 months and 9 days
|
|
Metabolism and nutrition disorders
METABOLIC/LABORATORY:: Albumin, serum-low (hypoalbuminemia)
|
64.5%
20/31 • Number of events 49 • 67 months and 9 days
|
|
Metabolism and nutrition disorders
METABOLIC/LABORATORY:: Alkaline phosphatase
|
51.6%
16/31 • Number of events 22 • 67 months and 9 days
|
|
Metabolism and nutrition disorders
METABOLIC/LABORATORY:: Amylase
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
Metabolism and nutrition disorders
METABOLIC/LABORATORY:: Bicarbonate, serum-low
|
12.9%
4/31 • Number of events 6 • 67 months and 9 days
|
|
Metabolism and nutrition disorders
METABOLIC/LABORATORY:: Bilirubin (hyperbilirubinemia)
|
32.3%
10/31 • Number of events 12 • 67 months and 9 days
|
|
Metabolism and nutrition disorders
METABOLIC/LABORATORY:: Calcium, serum-high (hypercalcemia)
|
6.5%
2/31 • Number of events 2 • 67 months and 9 days
|
|
Metabolism and nutrition disorders
METABOLIC/LABORATORY:: Calcium, serum-low (hypocalcemia)
|
61.3%
19/31 • Number of events 44 • 67 months and 9 days
|
|
Metabolism and nutrition disorders
METABOLIC/LABORATORY:: Creatinine
|
9.7%
3/31 • Number of events 3 • 67 months and 9 days
|
|
Metabolism and nutrition disorders
METABOLIC/LABORATORY:: Glucose, serum-high (hyperglycemia)
|
54.8%
17/31 • Number of events 47 • 67 months and 9 days
|
|
Metabolism and nutrition disorders
METABOLIC/LABORATORY:: Glucose, serum-low (hypoglycemia)
|
19.4%
6/31 • Number of events 6 • 67 months and 9 days
|
|
Metabolism and nutrition disorders
METABOLIC/LABORATORY:: Magnesium, serum-high (hypermagnesemia)
|
48.4%
15/31 • Number of events 30 • 67 months and 9 days
|
|
Metabolism and nutrition disorders
METABOLIC/LABORATORY:: Magnesium, serum-low (hypomagnesemia)
|
58.1%
18/31 • Number of events 28 • 67 months and 9 days
|
|
Metabolism and nutrition disorders
METABOLIC/LABORATORY:: Phosphate, serum-low (hypophosphatemia)
|
51.6%
16/31 • Number of events 26 • 67 months and 9 days
|
|
Metabolism and nutrition disorders
METABOLIC/LABORATORY:: Potassium, serum-high (hyperkalemia)
|
29.0%
9/31 • Number of events 10 • 67 months and 9 days
|
|
Metabolism and nutrition disorders
METABOLIC/LABORATORY:: Potassium, serum-low (hypokalemia)
|
54.8%
17/31 • Number of events 26 • 67 months and 9 days
|
|
Metabolism and nutrition disorders
METABOLIC/LABORATORY:: Sodium, serum-high (hypernatremia)
|
12.9%
4/31 • Number of events 4 • 67 months and 9 days
|
|
Metabolism and nutrition disorders
METABOLIC/LABORATORY:: Sodium, serum-low (hyponatremia)
|
51.6%
16/31 • Number of events 28 • 67 months and 9 days
|
|
Metabolism and nutrition disorders
METABOLIC/LABORATORY:: Uric acid, serum-high (hyperuricemia)
|
16.1%
5/31 • Number of events 5 • 67 months and 9 days
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL/SOFT TISSUE:: Arthritis (non-septic)
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL/SOFT TISSUE:: Joint-effusion
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL/SOFT TISSUE:: Muscle weakness, generalized or specific area (not due to neuropathy)
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL/SOFT TISSUE:: Musculoskeletal/Soft Tissue - Other (Specify, __)
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL/SOFT TISSUE:: Soft tissue necrosis:: Extremity-lower
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
Nervous system disorders
NEUROLOGY:: Confusion
|
9.7%
3/31 • Number of events 3 • 67 months and 9 days
|
|
Nervous system disorders
NEUROLOGY:: Dizziness
|
29.0%
9/31 • Number of events 12 • 67 months and 9 days
|
|
Nervous system disorders
NEUROLOGY:: Laryngeal nerve dysfunction
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
Nervous system disorders
NEUROLOGY:: Mood alteration:: Agitation
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
Nervous system disorders
NEUROLOGY:: Mood alteration:: Anxiety
|
9.7%
3/31 • Number of events 3 • 67 months and 9 days
|
|
Nervous system disorders
NEUROLOGY:: Mood alteration:: Depression
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
Nervous system disorders
NEUROLOGY:: Neuropathy: motor
|
9.7%
3/31 • Number of events 3 • 67 months and 9 days
|
|
Nervous system disorders
NEUROLOGY:: Neuropathy: sensory
|
77.4%
24/31 • Number of events 24 • 67 months and 9 days
|
|
Nervous system disorders
NEUROLOGY:: Somnolence/depressed level of consciousness
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
Nervous system disorders
NEUROLOGY:: Syncope (fainting)
|
6.5%
2/31 • Number of events 2 • 67 months and 9 days
|
|
Nervous system disorders
NEUROLOGY:: Tremor
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
Eye disorders
OCULAR/VISUAL:: Ocular/Visual - Other (Specify, red eyes)
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
Eye disorders
OCULAR/VISUAL:: Ophthalmoplegia/diplopia (double vision)
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
Eye disorders
OCULAR/VISUAL:: Vision-blurred vision
|
9.7%
3/31 • Number of events 3 • 67 months and 9 days
|
|
Eye disorders
OCULAR/VISUAL:: Vision-photophobia
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
Eye disorders
OCULAR/VISUAL:: Watery eye (epiphora, tearing)
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
General disorders
PAIN:: Pain - Other (Specify, L wrist)
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
Gastrointestinal disorders
PAIN:: Pain:: Abdomen Not otherwise specified (NOS)
|
22.6%
7/31 • Number of events 9 • 67 months and 9 days
|
|
Musculoskeletal and connective tissue disorders
PAIN:: Pain:: Back
|
22.6%
7/31 • Number of events 9 • 67 months and 9 days
|
|
Renal and urinary disorders
PAIN:: Pain:: Bladder
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
Musculoskeletal and connective tissue disorders
PAIN:: Pain:: Bone
|
38.7%
12/31 • Number of events 20 • 67 months and 9 days
|
|
Musculoskeletal and connective tissue disorders
PAIN:: Pain:: Buttock
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
Respiratory, thoracic and mediastinal disorders
PAIN:: Pain:: Chest/thorax NOS
|
16.1%
5/31 • Number of events 6 • 67 months and 9 days
|
|
Gastrointestinal disorders
PAIN:: Pain:: Dental/teeth/peridontal
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
Musculoskeletal and connective tissue disorders
PAIN:: Pain:: Extremity-limb
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
Eye disorders
PAIN:: Pain:: Eye
|
6.5%
2/31 • Number of events 2 • 67 months and 9 days
|
|
Nervous system disorders
PAIN:: Pain:: Head/headache
|
41.9%
13/31 • Number of events 22 • 67 months and 9 days
|
|
Musculoskeletal and connective tissue disorders
PAIN:: Pain:: Joint
|
16.1%
5/31 • Number of events 6 • 67 months and 9 days
|
|
Musculoskeletal and connective tissue disorders
PAIN:: Pain:: Muscle
|
32.3%
10/31 • Number of events 11 • 67 months and 9 days
|
|
Musculoskeletal and connective tissue disorders
PAIN:: Pain:: Neck
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
Gastrointestinal disorders
PAIN:: Pain:: Rectum
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
Respiratory, thoracic and mediastinal disorders
PAIN:: Pain:: Throat/pharynx/larynx
|
3.2%
1/31 • Number of events 2 • 67 months and 9 days
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY/UPPER RESPIRATORY:: Bronchospasm, wheezing
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY/UPPER RESPIRATORY:: Cough
|
22.6%
7/31 • Number of events 8 • 67 months and 9 days
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY/UPPER RESPIRATORY:: Dyspnea (shortness of breath)
|
19.4%
6/31 • Number of events 8 • 67 months and 9 days
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY/UPPER RESPIRATORY:: Hypoxia
|
6.5%
2/31 • Number of events 2 • 67 months and 9 days
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY/UPPER RESPIRATORY:: Nasal cavity/paranasal sinus reactions
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY/UPPER RESPIRATORY:: Pleural effusion (non-malignant)
|
6.5%
2/31 • Number of events 3 • 67 months and 9 days
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY/UPPER RESPIRATORY:: Pneumonitis/pulmonary infiltrates
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
Renal and urinary disorders
RENAL/GENITOURINARY:: Cystitis
|
19.4%
6/31 • Number of events 6 • 67 months and 9 days
|
|
Renal and urinary disorders
RENAL/GENITOURINARY:: Incontinence, urinary
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
Renal and urinary disorders
RENAL/GENITOURINARY:: Obstruction, GU:: Ureter
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
Renal and urinary disorders
RENAL/GENITOURINARY:: Urinary frequency/urgency
|
16.1%
5/31 • Number of events 6 • 67 months and 9 days
|
|
Vascular disorders
VASCULAR:: Phlebitis (including superficial thrombosis)
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
Vascular disorders
VASCULAR:: Thrombosis/embolism (vascular access-related)
|
9.7%
3/31 • Number of events 3 • 67 months and 9 days
|
|
Vascular disorders
VASCULAR:: Thrombosis/thrombus/embolism
|
16.1%
5/31 • Number of events 5 • 67 months and 9 days
|
|
Gastrointestinal disorders
GASTROINTESTINAL:: Gastrointestinal - Other (Specify, tongue-blue spot)
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
Eye disorders
OCULAR/VISUAL:: Ocular/Visual - Other (Specify, dilated, non-reactive R.pupil
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
Musculoskeletal and connective tissue disorders
PAIN:: Pain - Other (Specify, lumbar puncture (LP) site)
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
Musculoskeletal and connective tissue disorders
PAIN:: Pain - Other (Specify, Pain L big toe
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
Gastrointestinal disorders
PAIN:: Pain - Other (Specify, Pain: jaw pain)
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
Gastrointestinal disorders
PAIN:: Pain - Other (Specify, Pain:teeth)
|
3.2%
1/31 • Number of events 2 • 67 months and 9 days
|
|
Gastrointestinal disorders
PAIN:: Pain - Other (Specify, Pain: tooth
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
|
Reproductive system and breast disorders
PAIN:: Pain - Other (Specify, Pain:groin)
|
3.2%
1/31 • Number of events 1 • 67 months and 9 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place