Trial Outcomes & Findings for Campath-1H for Treating Adult T-Cell Leukemia/Lymphoma (NCT NCT00061048)
NCT ID: NCT00061048
Last Updated: 2012-10-31
Results Overview
Overall response rate is defined as the percentage of participants with response and utilizes the International Standardized workshop definition. Complete response(CR)-Complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease related symptoms if present before therapy and normalization of those biochemical abnormalities (for example LDH) definitely assignable to the lymphoma. Please see the protocol Link module for the full criteria if desired.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
29 participants
Primary outcome timeframe
60 months
Results posted on
2012-10-31
Participant Flow
Anticipate enrolling 10-12 patients per year into the Campath-1H trial. Thus, if the trial goes to completion (2nd stage)we anticipate enrolling the 29 patients in approximately 2.5 years.
Participant milestones
| Measure |
Campath-1H Treatment of Adult T-cell Leukemia (ATL)
Intravenous Campath-1H 3 mg on day #1, 10mg on day #2, and 30mg on day #3 followed by maintenance Campath-1H 30 mg intravenously three times per week. Patients are eligible to receive a maximum of 12 weeks of maintenance Campath-1H treatment.
|
|---|---|
|
Overall Study
STARTED
|
29
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
22
|
Reasons for withdrawal
| Measure |
Campath-1H Treatment of Adult T-cell Leukemia (ATL)
Intravenous Campath-1H 3 mg on day #1, 10mg on day #2, and 30mg on day #3 followed by maintenance Campath-1H 30 mg intravenously three times per week. Patients are eligible to receive a maximum of 12 weeks of maintenance Campath-1H treatment.
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
disease progression
|
20
|
Baseline Characteristics
Campath-1H for Treating Adult T-Cell Leukemia/Lymphoma
Baseline characteristics by cohort
| Measure |
Campath-1H Treatment of Adult T-cell Leukemia (ATL)
n=29 Participants
Intravenous Campath-1H 3 mg on day #1, 10mg on day #2, and 30mg on day #3 followed by maintenance Campath-1H 30 mg intravenously three times per week. Patients are eligible to receive a maximum of 12 weeks of maintenance Campath-1H treatment.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
|
Age Continuous
|
52.54 years
STANDARD_DEVIATION 13.39 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 60 monthsOverall response rate is defined as the percentage of participants with response and utilizes the International Standardized workshop definition. Complete response(CR)-Complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease related symptoms if present before therapy and normalization of those biochemical abnormalities (for example LDH) definitely assignable to the lymphoma. Please see the protocol Link module for the full criteria if desired.
Outcome measures
| Measure |
Campath-1H Treatment of Adult T-cell Leukemia (ATL)
n=29 Participants
Intravenous Campath-1H 3 mg on day #1, 10mg on day #2, and 30mg on day #3 followed by maintenance Campath-1H 30 mg intravenously three times per week. Patients are eligible to receive a maximum of 12 weeks of maintenance Campath-1H treatment.
|
|---|---|
|
Overall Response Rate
|
52 percentage of participants
Interval 32.5 to 70.6
|
PRIMARY outcome
Timeframe: 60 monthsTime between the first day of treatment to the day of death.
Outcome measures
| Measure |
Campath-1H Treatment of Adult T-cell Leukemia (ATL)
n=29 Participants
Intravenous Campath-1H 3 mg on day #1, 10mg on day #2, and 30mg on day #3 followed by maintenance Campath-1H 30 mg intravenously three times per week. Patients are eligible to receive a maximum of 12 weeks of maintenance Campath-1H treatment.
|
|---|---|
|
Overall Survival
|
5.9 months
Interval 4.7 to 8.7
|
PRIMARY outcome
Timeframe: 60 monthsTime between the first day of treatment to the day of disease progression which is defined as a persistent (at least two determinations) doubling of the peripheral blood leukemic cell count, the development of new lesions, or Ca elevations that are uncontrolled by conventional therapeutic procedures.
Outcome measures
| Measure |
Campath-1H Treatment of Adult T-cell Leukemia (ATL)
n=29 Participants
Intravenous Campath-1H 3 mg on day #1, 10mg on day #2, and 30mg on day #3 followed by maintenance Campath-1H 30 mg intravenously three times per week. Patients are eligible to receive a maximum of 12 weeks of maintenance Campath-1H treatment.
|
|---|---|
|
Time to Progression
|
2.0 months
Interval 1.0 to 3.9
|
SECONDARY outcome
Timeframe: 6 monthsThe CD52 antibody-binding capacity (ABC) value is the measurement of the mean value of the maximum capacity of each cell to bind the anti-CD52 and when determined under conditions of saturating levels of antibody measures number of mean surface CD52 antigens per cell. CD52 ABC is negative when 100% saturation by therapeutic antibody is achieved.
Outcome measures
| Measure |
Campath-1H Treatment of Adult T-cell Leukemia (ATL)
n=29 Participants
Intravenous Campath-1H 3 mg on day #1, 10mg on day #2, and 30mg on day #3 followed by maintenance Campath-1H 30 mg intravenously three times per week. Patients are eligible to receive a maximum of 12 weeks of maintenance Campath-1H treatment.
|
|---|---|
|
Cell Surface Expression of CD52 on Tumor Cells
|
82.15 ABC value
Standard Deviation 13.7
|
SECONDARY outcome
Timeframe: 18 monthsHere are the total number of participants with adverse events. For the detailed list of adverse events see the adverse event module.
Outcome measures
| Measure |
Campath-1H Treatment of Adult T-cell Leukemia (ATL)
n=29 Participants
Intravenous Campath-1H 3 mg on day #1, 10mg on day #2, and 30mg on day #3 followed by maintenance Campath-1H 30 mg intravenously three times per week. Patients are eligible to receive a maximum of 12 weeks of maintenance Campath-1H treatment.
|
|---|---|
|
The Number of Participants With Adverse Events
|
8 participants
|
Adverse Events
Campath-1H Treatment of Adult T-cell Leukemia (ATL)
Serious events: 8 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Campath-1H Treatment of Adult T-cell Leukemia (ATL)
n=29 participants at risk
Intravenous Campath-1H 3 mg on day #1, 10mg on day #2, and 30mg on day #3 followed by maintenance Campath-1H 30 mg intravenously three times per week. Patients are eligible to receive a maximum of 12 weeks of maintenance Campath-1H treatment.
|
|---|---|
|
Vascular disorders
CARDIOVASCULAR (GENERAL):: Hypotension
|
3.4%
1/29 • Number of events 1 • 5 years
|
|
General disorders
CONSTITUTIONAL SYMPTOMS:: Constitutional Symptoms-Other (death)
|
6.9%
2/29 • Number of events 2 • 5 years
|
|
General disorders
CONSTITUTIONAL SYMPTOMS:: Fatigue (lethargy, malaise, asthenia)
|
3.4%
1/29 • Number of events 1 • 5 years
|
|
General disorders
CONSTITUTIONAL SYMPTOMS:: Rigors, chills
|
3.4%
1/29 • Number of events 1 • 5 years
|
|
Endocrine disorders
ENDOCRINE:: Endocrine-Other (Endocrine:hyperthyroidism graves disease)
|
3.4%
1/29 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
GASTROINTESTINAL:: Vomiting
|
3.4%
1/29 • Number of events 1 • 5 years
|
|
Infections and infestations
INFECTION/FEBRILE NEUTROPENIA:: Infection without neutropenia
|
3.4%
1/29 • Number of events 1 • 5 years
|
|
Metabolism and nutrition disorders
METABOLIC/LABORATORY:: Hypercalcemia
|
3.4%
1/29 • Number of events 1 • 5 years
|
|
Nervous system disorders
NEUROLOGY:: Neurology-Other (Unresponsiveness)
|
3.4%
1/29 • Number of events 1 • 5 years
|
|
Eye disorders
OCULAR/VISUAL:: Vision-blurred vision
|
3.4%
1/29 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY:: Apnea
|
3.4%
1/29 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY:: Hypoxia
|
3.4%
1/29 • Number of events 1 • 5 years
|
Other adverse events
| Measure |
Campath-1H Treatment of Adult T-cell Leukemia (ATL)
n=29 participants at risk
Intravenous Campath-1H 3 mg on day #1, 10mg on day #2, and 30mg on day #3 followed by maintenance Campath-1H 30 mg intravenously three times per week. Patients are eligible to receive a maximum of 12 weeks of maintenance Campath-1H treatment.
|
|---|---|
|
Gastrointestinal disorders
GASTROINTESTINAL:: Dysphagia, esophagitis, odynophagia (painful swallowing)
|
3.4%
1/29 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
GASTROINTESTINAL:: Flatulence
|
3.4%
1/29 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
GASTROINTESTINAL:: Gastrointestinal-Other (Abdominal distention)
|
3.4%
1/29 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
GASTROINTESTINAL:: Mouth dryness
|
3.4%
1/29 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
GASTROINTESTINAL:: Nausea
|
37.9%
11/29 • Number of events 13 • 5 years
|
|
Gastrointestinal disorders
GASTROINTESTINAL:: Stomatitis/pharyngitis (oral/pharyngeal mucositis)
|
10.3%
3/29 • Number of events 5 • 5 years
|
|
Gastrointestinal disorders
GASTROINTESTINAL:: Vomiting
|
34.5%
10/29 • Number of events 12 • 5 years
|
|
Blood and lymphatic system disorders
HEMORRHAGE:: Epistaxis
|
24.1%
7/29 • Number of events 7 • 5 years
|
|
Blood and lymphatic system disorders
HEMORRHAGE:: Vaginal bleeding
|
3.4%
1/29 • Number of events 1 • 5 years
|
|
Hepatobiliary disorders
HEPATIC:: Alkaline phosphatase
|
27.6%
8/29 • Number of events 10 • 5 years
|
|
Hepatobiliary disorders
HEPATIC:: Bilirubin
|
17.2%
5/29 • Number of events 11 • 5 years
|
|
Hepatobiliary disorders
HEPATIC:: GGT (Gamma-Glutamyl transpeptidase)
|
3.4%
1/29 • Number of events 1 • 5 years
|
|
Hepatobiliary disorders
HEPATIC:: Hypoalbuminemia
|
48.3%
14/29 • Number of events 38 • 5 years
|
|
Hepatobiliary disorders
HEPATIC:: SGOT (AST) (serum glutamic oxaloacetic transaminase)
|
41.4%
12/29 • Number of events 22 • 5 years
|
|
Hepatobiliary disorders
HEPATIC:: SGPT (ALT) (serum glutamic pyruvic transaminase)
|
31.0%
9/29 • Number of events 14 • 5 years
|
|
Blood and lymphatic system disorders
INFECTION/FEBRILE NEUTROPENIA:: Catheter-related infection
|
3.4%
1/29 • Number of events 1 • 5 years
|
|
Blood and lymphatic system disorders
INFECTION/FEBRILE NEUTROPENIA:: Febrile neutropenia (fever of unknown origin without clinically or m
|
3.4%
1/29 • Number of events 1 • 5 years
|
|
Blood and lymphatic system disorders
INFECTION/FEBRILE NEUTROPENIA:: Infection (documented clinically or microbiologically) with grade 3
|
3.4%
1/29 • Number of events 1 • 5 years
|
|
Blood and lymphatic system disorders
INFECTION/FEBRILE NEUTROPENIA:: Infection without neutropenia
|
31.0%
9/29 • Number of events 17 • 5 years
|
|
Blood and lymphatic system disorders
INFECTION/FEBRILE NEUTROPENIA:: Infection/Febrile Neutropenia-Other (CMV antigenemia)
|
17.2%
5/29 • Number of events 5 • 5 years
|
|
Blood and lymphatic system disorders
LYMPHATICS:: Lymphatics
|
3.4%
1/29 • Number of events 1 • 5 years
|
|
Blood and lymphatic system disorders
LYMPHATICS:: Lymphatics-Other (Lymphocytes)
|
3.4%
1/29 • Number of events 1 • 5 years
|
|
Investigations
METABOLIC/LABORATORY:: Amylase
|
6.9%
2/29 • Number of events 3 • 5 years
|
|
Investigations
METABOLIC/LABORATORY:: Bicarbonate
|
6.9%
2/29 • Number of events 2 • 5 years
|
|
Investigations
METABOLIC/LABORATORY:: CPK (creatine phosphokinase)
|
6.9%
2/29 • Number of events 2 • 5 years
|
|
Investigations
METABOLIC/LABORATORY:: Hypercalcemia
|
17.2%
5/29 • Number of events 14 • 5 years
|
|
Investigations
METABOLIC/LABORATORY:: Hypercholesterolemia
|
3.4%
1/29 • Number of events 1 • 5 years
|
|
Investigations
METABOLIC/LABORATORY:: Hyperglycemia
|
44.8%
13/29 • Number of events 34 • 5 years
|
|
Investigations
METABOLIC/LABORATORY:: Hyperkalemia
|
3.4%
1/29 • Number of events 3 • 5 years
|
|
Investigations
METABOLIC/LABORATORY:: Hypermagnesemia
|
24.1%
7/29 • Number of events 12 • 5 years
|
|
Investigations
METABOLIC/LABORATORY:: Hypernatremia
|
3.4%
1/29 • Number of events 1 • 5 years
|
|
Investigations
METABOLIC/LABORATORY:: Hyperuricemia
|
20.7%
6/29 • Number of events 12 • 5 years
|
|
Investigations
METABOLIC/LABORATORY:: Hypocalcemia
|
17.2%
5/29 • Number of events 20 • 5 years
|
|
Investigations
METABOLIC/LABORATORY:: Hypoglycemia
|
13.8%
4/29 • Number of events 4 • 5 years
|
|
Investigations
METABOLIC/LABORATORY:: Hypokalemia
|
31.0%
9/29 • Number of events 18 • 5 years
|
|
Investigations
METABOLIC/LABORATORY:: Hypomagnesemia
|
31.0%
9/29 • Number of events 33 • 5 years
|
|
Investigations
METABOLIC/LABORATORY:: Hyponatremia
|
34.5%
10/29 • Number of events 27 • 5 years
|
|
Investigations
METABOLIC/LABORATORY:: Hypophosphatemia
|
20.7%
6/29 • Number of events 19 • 5 years
|
|
Investigations
METABOLIC/LABORATORY:: Lipase
|
3.4%
1/29 • Number of events 1 • 5 years
|
|
Investigations
METABOLIC/LABORATORY:: Metabolic/Laboratory-Other (Lactate)
|
3.4%
1/29 • Number of events 1 • 5 years
|
|
Nervous system disorders
NEUROLOGY:: Dizziness/lightheadedness
|
13.8%
4/29 • Number of events 4 • 5 years
|
|
Psychiatric disorders
NEUROLOGY:: Insomnia
|
17.2%
5/29 • Number of events 5 • 5 years
|
|
Psychiatric disorders
NEUROLOGY:: Mood alteration-anxiety, agitation
|
3.4%
1/29 • Number of events 1 • 5 years
|
|
Psychiatric disorders
NEUROLOGY:: Mood alteration-depression
|
3.4%
1/29 • Number of events 1 • 5 years
|
|
Nervous system disorders
NEUROLOGY:: Neuropathy - cranial
|
3.4%
1/29 • Number of events 1 • 5 years
|
|
Nervous system disorders
NEUROLOGY:: Neuropathy - motor
|
10.3%
3/29 • Number of events 3 • 5 years
|
|
Eye disorders
OCULAR/VISUAL:: Dry eye
|
3.4%
1/29 • Number of events 1 • 5 years
|
|
Eye disorders
OCULAR/VISUAL:: Ocular/Visual-Other (Ocular other: uveitis)
|
3.4%
1/29 • Number of events 1 • 5 years
|
|
Eye disorders
OCULAR/VISUAL:: Tearing (watery eyes)
|
3.4%
1/29 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
OCULAR/VISUAL:: Vision-blurred vision
|
6.9%
2/29 • Number of events 2 • 5 years
|
|
Eye disorders
OCULAR/VISUAL:: Vision-double vision (diplopia)
|
6.9%
2/29 • Number of events 2 • 5 years
|
|
Eye disorders
OCULAR/VISUAL:: Vision-photophobia
|
3.4%
1/29 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
PAIN:: Abdominal pain or cramping
|
6.9%
2/29 • Number of events 2 • 5 years
|
|
Musculoskeletal and connective tissue disorders
PAIN:: Arthralgia (joint pain)
|
10.3%
3/29 • Number of events 3 • 5 years
|
|
Musculoskeletal and connective tissue disorders
PAIN:: Bone pain
|
6.9%
2/29 • Number of events 2 • 5 years
|
|
General disorders
PAIN:: Chest pain (non-cardiac and non-pleuritic)
|
13.8%
4/29 • Number of events 4 • 5 years
|
|
Ear and labyrinth disorders
PAIN:: Earache (otalgia)
|
3.4%
1/29 • Number of events 1 • 5 years
|
|
Nervous system disorders
PAIN:: Headache
|
24.1%
7/29 • Number of events 11 • 5 years
|
|
Musculoskeletal and connective tissue disorders
PAIN:: Myalgia (muscle pain)
|
24.1%
7/29 • Number of events 13 • 5 years
|
|
Nervous system disorders
PAIN:: Pain-Other (Dental-anterior pillars tender;Foot, sharp and intermittent;Right eye ache)
|
20.7%
6/29 • Number of events 7 • 5 years
|
|
Reproductive system and breast disorders
PAIN:: Pelvic pain
|
3.4%
1/29 • Number of events 1 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PAIN:: Tumor pain (onset or exacerbation of tumor pain due to treatment)
|
3.4%
1/29 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY:: Cough
|
17.2%
5/29 • Number of events 7 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY:: Dyspnea (shortness of breath)
|
10.3%
3/29 • Number of events 3 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY:: Hypoxia
|
6.9%
2/29 • Number of events 5 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY:: Pneumonitis/pulmonary infiltrates
|
3.4%
1/29 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY:: Pneumothorax
|
3.4%
1/29 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
RENAL/GENITOURINARY:: Creatinine
|
10.3%
3/29 • Number of events 5 • 5 years
|
|
Renal and urinary disorders
RENAL/GENITOURINARY:: Hemoglobinuria
|
3.4%
1/29 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
RENAL/GENITOURINARY:: Proteinuria
|
10.3%
3/29 • Number of events 4 • 5 years
|
|
Renal and urinary disorders
RENAL/GENITOURINARY:: Renal/Genitourinary-Other (Urine positive for white blood cells)
|
6.9%
2/29 • Number of events 2 • 5 years
|
|
Skin and subcutaneous tissue disorders
DERMATOLOGY/SKIN::Dermatology/Skin-Other(Thumb swelling)
|
3.4%
1/29 • Number of events 1 • 5 years
|
|
Immune system disorders
ALLERGY/IMMUNOLOGY:: Allergic reaction/hypersensitivity (including drug fever)
|
6.9%
2/29 • Number of events 2 • 5 years
|
|
Immune system disorders
ALLERGY/IMMUNOLOGY:: Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
|
6.9%
2/29 • Number of events 2 • 5 years
|
|
Investigations
BLOOD/BONE MARROW:: Hemoglobin
|
69.0%
20/29 • Number of events 81 • 5 years
|
|
Investigations
BLOOD/BONE MARROW:: Leukocytes (total WBC)
|
51.7%
15/29 • Number of events 106 • 5 years
|
|
Investigations
BLOOD/BONE MARROW:: Lymphopenia
|
62.1%
18/29 • Number of events 26 • 5 years
|
|
Investigations
BLOOD/BONE MARROW:: Neutrophils/granulocytes (ANC/AGC)
|
37.9%
11/29 • Number of events 54 • 5 years
|
|
Investigations
BLOOD/BONE MARROW:: Platelets
|
55.2%
16/29 • Number of events 41 • 5 years
|
|
Cardiac disorders
CARDIOVASCULAR (ARRHYTHMIA):: Cardiovascular/Arrhythmia-Other (irregular heartbeat))
|
3.4%
1/29 • Number of events 1 • 5 years
|
|
Cardiac disorders
CARDIOVASCULAR (ARRHYTHMIA):: Sinus bradycardia
|
3.4%
1/29 • Number of events 2 • 5 years
|
|
Cardiac disorders
CARDIOVASCULAR (ARRHYTHMIA):: Sinus tachycardia
|
17.2%
5/29 • Number of events 13 • 5 years
|
|
Cardiac disorders
CARDIOVASCULAR (ARRHYTHMIA):: Vasovagal episode
|
10.3%
3/29 • Number of events 3 • 5 years
|
|
Cardiac disorders
CARDIOVASCULAR (GENERAL):: Edema
|
17.2%
5/29 • Number of events 7 • 5 years
|
|
Vascular disorders
CARDIOVASCULAR (GENERAL):: Hypertension
|
6.9%
2/29 • Number of events 2 • 5 years
|
|
Vascular disorders
CARDIOVASCULAR (GENERAL):: Hypotension
|
37.9%
11/29 • Number of events 15 • 5 years
|
|
Cardiac disorders
CARDIOVASCULAR (GENERAL):: Phlebitis (superficial)
|
6.9%
2/29 • Number of events 2 • 5 years
|
|
Investigations
COAGULATION:: Partial thromboplastin time (PTT)
|
13.8%
4/29 • Number of events 5 • 5 years
|
|
Investigations
COAGULATION:: Prothrombin time (PT)
|
6.9%
2/29 • Number of events 2 • 5 years
|
|
General disorders
CONSTITUTIONAL SYMPTOMS:: Fatigue (lethargy, malaise, asthenia)
|
17.2%
5/29 • Number of events 6 • 5 years
|
|
General disorders
CONSTITUTIONAL SYMPTOMS:: Fever (in the absence of neutropenia, where neutropenia is defined as AGC<
|
75.9%
22/29 • Number of events 68 • 5 years
|
|
General disorders
CONSTITUTIONAL SYMPTOMS:: Rigors, chills
|
86.2%
25/29 • Number of events 48 • 5 years
|
|
General disorders
CONSTITUTIONAL SYMPTOMS:: Sweating (diaphoresis)
|
3.4%
1/29 • Number of events 1 • 5 years
|
|
General disorders
CONSTITUTIONAL SYMPTOMS:: Weight gain
|
3.4%
1/29 • Number of events 1 • 5 years
|
|
General disorders
CONSTITUTIONAL SYMPTOMS:: Weight loss
|
10.3%
3/29 • Number of events 6 • 5 years
|
|
Skin and subcutaneous tissue disorders
DERMATOLOGY/SKIN:: Bruising (in absence of grade 3 or 4 thrombocytopenia)
|
3.4%
1/29 • Number of events 2 • 5 years
|
|
Skin and subcutaneous tissue disorders
DERMATOLOGY/SKIN:: Dry skin
|
10.3%
3/29 • Number of events 3 • 5 years
|
|
Skin and subcutaneous tissue disorders
DERMATOLOGY/SKIN:: Injection site reaction
|
3.4%
1/29 • Number of events 1 • 5 years
|
|
Skin and subcutaneous tissue disorders
DERMATOLOGY/SKIN:: Pruritus
|
27.6%
8/29 • Number of events 10 • 5 years
|
|
Skin and subcutaneous tissue disorders
DERMATOLOGY/SKIN:: Rash/desquamation
|
27.6%
8/29 • Number of events 12 • 5 years
|
|
Skin and subcutaneous tissue disorders
DERMATOLOGY/SKIN:: Urticaria (hives, welts, wheals)
|
37.9%
11/29 • Number of events 15 • 5 years
|
|
Endocrine disorders
ENDOCRINE:: Hypothyroidism
|
3.4%
1/29 • Number of events 2 • 5 years
|
|
Gastrointestinal disorders
GASTROINTESTINAL:: Anorexia
|
20.7%
6/29 • Number of events 6 • 5 years
|
|
Gastrointestinal disorders
GASTROINTESTINAL:: Constipation
|
31.0%
9/29 • Number of events 13 • 5 years
|
|
Gastrointestinal disorders
GASTROINTESTINAL:: Diarrhea patients without colostomy
|
34.5%
10/29 • Number of events 11 • 5 years
|
|
Gastrointestinal disorders
GASTROINTESTINAL:: Dyspepsia/heartburn
|
10.3%
3/29 • Number of events 3 • 5 years
|
Additional Information
Thomas A. Waldmann, M.D.
National Cancer Institute, National Institutes of Health
Phone: 301-496-6653
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place