Trial Outcomes & Findings for Anti-Tac(90 Y-HAT) to Treat Hodgkin's Disease, Non-Hodgkin's Lymphoma and Lymphoid Leukemia (NCT NCT00001575)
NCT ID: NCT00001575
Last Updated: 2015-12-07
Results Overview
Phase I portion maximum tolerated dose (MTD) is defined as the dose level below the dose at which 2 out of 2-6 patients develop DLT (if any patient develops grade IV toxicity of any type (excluding grade IV neutropenia) or grade III non-hematologic toxicity that patient may not continue on the study at the same dose level and therefore has had a dose limiting toxicity). There can be no more than 1 out of 6 patients with DLT at the MTD. The MTD will be assessed using only the results from the first cycle of therapy.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
87 participants
Primary outcome timeframe
Patients could receive 90Y-HAT 15mCi per cycle and complete up to a maximum of 7 doses or 2 doses by the average of every 6 weeks.
Results posted on
2015-12-07
Participant Flow
All ph I pts who received an initial bone marrow transplantation received an initial dose of 10mCi followed by 15mCi. At the discretion of the PI on the basis of persistent reduced hematopoietic values, a subsequent dose may have been reduced from 15mCi to 10mCi or 5mCi. All ph II pts received at least one dose of 10mCi and/or 15mCi, or 20mCi.
Participant milestones
| Measure |
Anti-Tac Yttrium 90-labeled Humanized Anti-Tac (90 Y-HAT)
10 mCi (if a bone marrow transplant was part of the patient's previous therapy) or 15 mCi of yttrium labeled anti-TAC; followed by calcium trisodium Inj (Ca DTPA).
Ca-DTPA will be administered intravenously on Days 1-3 to clear the radioactive agent from the body
|
|---|---|
|
Overall Study
STARTED
|
87
|
|
Overall Study
Treated
|
65
|
|
Overall Study
COMPLETED
|
42
|
|
Overall Study
NOT COMPLETED
|
45
|
Reasons for withdrawal
| Measure |
Anti-Tac Yttrium 90-labeled Humanized Anti-Tac (90 Y-HAT)
10 mCi (if a bone marrow transplant was part of the patient's previous therapy) or 15 mCi of yttrium labeled anti-TAC; followed by calcium trisodium Inj (Ca DTPA).
Ca-DTPA will be administered intravenously on Days 1-3 to clear the radioactive agent from the body
|
|---|---|
|
Overall Study
Screening failures-Ph I portion
|
22
|
|
Overall Study
Withdrawn/deaths
|
23
|
Baseline Characteristics
Anti-Tac(90 Y-HAT) to Treat Hodgkin's Disease, Non-Hodgkin's Lymphoma and Lymphoid Leukemia
Baseline characteristics by cohort
| Measure |
Anti-Tac Yttrium 90-labeled Humanized Anti-Tac (90 Y-HAT)
n=87 Participants
10 mCi (if a bone marrow transplant was part of the patient's previous therapy) or 15 mCi of yttrium labeled anti-TAC; followed by calcium trisodium Inj (Ca DTPA).
Ca-DTPA will be administered intravenously on Days 1-3 to clear the radioactive agent from the body
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
70 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
17 Participants
n=5 Participants
|
|
Age, Continuous
|
36 years
STANDARD_DEVIATION 16 • n=5 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
81 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
66 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
87 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Patients could receive 90Y-HAT 15mCi per cycle and complete up to a maximum of 7 doses or 2 doses by the average of every 6 weeks.Population: Phase I portion-maximum tolerated dose. Only the Hodgkin's participants was analyzed (i.e., 28).
Phase I portion maximum tolerated dose (MTD) is defined as the dose level below the dose at which 2 out of 2-6 patients develop DLT (if any patient develops grade IV toxicity of any type (excluding grade IV neutropenia) or grade III non-hematologic toxicity that patient may not continue on the study at the same dose level and therefore has had a dose limiting toxicity). There can be no more than 1 out of 6 patients with DLT at the MTD. The MTD will be assessed using only the results from the first cycle of therapy.
Outcome measures
| Measure |
Anti-Tac Yttrium 90-labeled Humanized Anti-Tac (90 Y-HAT)
n=28 Participants
10 mCi (if a bone marrow transplant was part of the patient's previous therapy) or 15 mCi of yttrium labeled anti-TAC; followed by calcium trisodium Inj (Ca DTPA).
Ca-DTPA will be administered intravenously on Days 1-3 to clear the radioactive agent from the body
|
|---|---|
|
Maximum Tolerated Dose (MTD) of 90Y-HAT
|
15 mci
|
PRIMARY outcome
Timeframe: Patient would be measured with computed tomography (CT) scan, Fludeoxyglucose (18F) positron-emission tomography (FDG PET) scan in 28 days before treatment. Patient would be evaluated with In-HAT imaging at Day 1,4,5,6 and Day 7 in week 1 of each cycle.Population: Phase II portion. Only the Hodgkin's participants was analyzed (i.e., added more Hodgkins participants to study).
Clinical Response of patient is measured by the Response Evaluation Criteria in Solid Tumors (RECIST). Tumor responses were evaluated by In-HAT imaging (i.e., simultaneous with administration of therapeutic 90Y-daclizumab), Fludeoxyglucose (18F) positron-emission tomography (FDG PET) scans and computed tomography (CT) scans. Complete response is a disappearance of all measurable and evaluable disease lasting more than I month. Partial response is a reduction by ≥ 50% of leukemic cell count or ≥ 50% reduction in the size of all measurable lesions, and no increase in size of any measurable or evaluable lesion or appearance of new lesions for 1 month. Stable disease is less than partial response with no more than a 25% increase in leukemic cell count, no new lesions, or less than a 25% increase in any measurable lesion. Progressive disease is at least a 25% increase in leukemic cell count, appearance of new lesions, or an increase of 25% or greater in any measurable lesion after 2 weeks.
Outcome measures
| Measure |
Anti-Tac Yttrium 90-labeled Humanized Anti-Tac (90 Y-HAT)
n=46 Participants
10 mCi (if a bone marrow transplant was part of the patient's previous therapy) or 15 mCi of yttrium labeled anti-TAC; followed by calcium trisodium Inj (Ca DTPA).
Ca-DTPA will be administered intravenously on Days 1-3 to clear the radioactive agent from the body
|
|---|---|
|
Clinical Response
Complete Response
|
14 participants
|
|
Clinical Response
Partial Response
|
9 participants
|
|
Clinical Response
Stable Disease
|
14 participants
|
|
Clinical Response
Progressive Disease
|
9 participants
|
SECONDARY outcome
Timeframe: 16 yrs 18 daysHere is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.
Outcome measures
| Measure |
Anti-Tac Yttrium 90-labeled Humanized Anti-Tac (90 Y-HAT)
n=64 Participants
10 mCi (if a bone marrow transplant was part of the patient's previous therapy) or 15 mCi of yttrium labeled anti-TAC; followed by calcium trisodium Inj (Ca DTPA).
Ca-DTPA will be administered intravenously on Days 1-3 to clear the radioactive agent from the body
|
|---|---|
|
Number of Participants With Adverse Events
|
57 participants
|
Adverse Events
Anti-Tac Yttrium 90-labeled Humanized Anti-Tac (90 Y-HAT)
Serious events: 8 serious events
Other events: 49 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Anti-Tac Yttrium 90-labeled Humanized Anti-Tac (90 Y-HAT)
n=64 participants at risk
10 mCi (if a bone marrow transplant was part of the patient's previous therapy) or 15 mCi of yttrium labeled anti-TAC; followed by calcium trisodium Inj (Ca DTPA).
Ca-DTPA will be administered intravenously on Days 1-3 to clear the radioactive agent from the body
|
|---|---|
|
Blood and lymphatic system disorders
BLOOD/BONE MARROW:: Bone marrow cellularity
|
1.6%
1/64 • Number of events 1
|
|
Cardiac disorders
CARDIOVASCULAR (GENERAL):: Hypotension
|
1.6%
1/64 • Number of events 1
|
|
Hepatobiliary disorders
HEPATIC:: Liver dysfunction/failure (clinical)
|
1.6%
1/64 • Number of events 1
|
|
General disorders
Multi-organ failure
|
1.6%
1/64 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY:: Pulmonary-Other (Specify, respiratory failure)
|
1.6%
1/64 • Number of events 1
|
|
Gastrointestinal disorders
PAIN:: Abdominal pain or cramping
|
1.6%
1/64 • Number of events 1
|
|
General disorders
PAIN:: Pain-Other (Specify, tooth pain)
|
1.6%
1/64 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY:: Hypoxia
|
1.6%
1/64 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY:: Pneumonitis/pulmonary infiltrates
|
1.6%
1/64 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Secondary Malignancy-Other (Specify,____) excludes metastasis from initial primary
|
1.6%
1/64 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SYNDROMES:: Syndromes-Other (Specify, MDS)
|
1.6%
1/64 • Number of events 1
|
Other adverse events
| Measure |
Anti-Tac Yttrium 90-labeled Humanized Anti-Tac (90 Y-HAT)
n=64 participants at risk
10 mCi (if a bone marrow transplant was part of the patient's previous therapy) or 15 mCi of yttrium labeled anti-TAC; followed by calcium trisodium Inj (Ca DTPA).
Ca-DTPA will be administered intravenously on Days 1-3 to clear the radioactive agent from the body
|
|---|---|
|
Immune system disorders
ALLERGY/IMMUNOLOGY:: Allergic reaction/hypersensitivity (including drug fever)
|
1.6%
1/64 • Number of events 1
|
|
Immune system disorders
ALLERGY/IMMUNOLOGY:: Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
|
3.1%
2/64 • Number of events 2
|
|
Immune system disorders
ALLERGY/IMMUNOLOGY:: Allergy-Other (Specify, sinus congestion)
|
1.6%
1/64 • Number of events 1
|
|
Ear and labyrinth disorders
AUDITORY/HEARING:: Auditory/Hearing-Other (Specify, pressure in right ear)
|
1.6%
1/64 • Number of events 1
|
|
Blood and lymphatic system disorders
BLOOD/BONE MARROW:: Hemoglobin
|
51.6%
33/64 • Number of events 109
|
|
Blood and lymphatic system disorders
BLOOD/BONE MARROW:: Leukocytes (total WBC)
|
50.0%
32/64 • Number of events 132
|
|
Blood and lymphatic system disorders
BLOOD/BONE MARROW:: Lymphopenia
|
57.8%
37/64 • Number of events 142
|
|
Blood and lymphatic system disorders
BLOOD/BONE MARROW:: Neutrophils/granulocytes (ANC/AGC)
|
23.4%
15/64 • Number of events 64
|
|
Blood and lymphatic system disorders
BLOOD/BONE MARROW:: Platelets
|
57.8%
37/64 • Number of events 115
|
|
Blood and lymphatic system disorders
BLOOD/BONE MARROW:: Transfusion: Platelets
|
1.6%
1/64 • Number of events 1
|
|
Cardiac disorders
CARDIOVASCULAR (ARRHYTHMIA):: Prolonged QTc interval (QTc > 0.48 seconds)
|
1.6%
1/64 • Number of events 1
|
|
Cardiac disorders
CARDIOVASCULAR (ARRHYTHMIA):: Sinus bradycardia
|
1.6%
1/64 • Number of events 1
|
|
Cardiac disorders
CARDIOVASCULAR (ARRHYTHMIA):: Sinus tachycardia
|
1.6%
1/64 • Number of events 1
|
|
Cardiac disorders
CARDIOVASCULAR (ARRHYTHMIA):: Supraventricular arrhythmias (SVT/atrial fibrillation/flutter)
|
1.6%
1/64 • Number of events 3
|
|
Cardiac disorders
CARDIOVASCULAR (GENERAL):: Edema
|
6.2%
4/64 • Number of events 4
|
|
Cardiac disorders
CARDIOVASCULAR (GENERAL):: Hypotension
|
15.6%
10/64 • Number of events 15
|
|
Blood and lymphatic system disorders
COAGULATION:: Partial thromboplastin time (PTT)
|
15.6%
10/64 • Number of events 19
|
|
Blood and lymphatic system disorders
COAGULATION:: Prothrombin time (PT)
|
9.4%
6/64 • Number of events 12
|
|
General disorders
CONSTITUTIONAL SYMPTOMS:: Fatigue (lethargy, malaise, asthenia)
|
12.5%
8/64 • Number of events 9
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 10e9/L)
|
28.1%
18/64 • Number of events 37
|
|
General disorders
CONSTITUTIONAL SYMPTOMS:: Rigors, chills
|
7.8%
5/64 • Number of events 6
|
|
General disorders
CONSTITUTIONAL SYMPTOMS:: Weight loss
|
1.6%
1/64 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
DERMATOLOGY/SKIN:: Dermatology/Skin-Other (Specify, eczematoid dermatitis)
|
1.6%
1/64 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
DERMATOLOGY/SKIN:: Dermatology/Skin-Other (Specify, rash; erythematous, eczematous)
|
1.6%
1/64 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
DERMATOLOGY/SKIN:: Dermatology/Skin-Other (Specify, skin lesions)
|
1.6%
1/64 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
DERMATOLOGY/SKIN:: Flushing
|
1.6%
1/64 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
DERMATOLOGY/SKIN:: Pruritus
|
7.8%
5/64 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
DERMATOLOGY/SKIN:: Rash/desquamation
|
12.5%
8/64 • Number of events 8
|
|
Endocrine disorders
ENDOCRINE:: Hot flashes/flushes
|
1.6%
1/64 • Number of events 1
|
|
Endocrine disorders
ENDOCRINE:: Hypothyroidism
|
1.6%
1/64 • Number of events 1
|
|
Gastrointestinal disorders
GASTROINTESTINAL:: Anorexia
|
6.2%
4/64 • Number of events 4
|
|
Gastrointestinal disorders
GASTROINTESTINAL:: Constipation
|
7.8%
5/64 • Number of events 5
|
|
Gastrointestinal disorders
GASTROINTESTINAL:: Dehydration
|
1.6%
1/64 • Number of events 1
|
|
Gastrointestinal disorders
GASTROINTESTINAL:: Diarrhea patients without colostomy
|
6.2%
4/64 • Number of events 5
|
|
Gastrointestinal disorders
GASTROINTESTINAL:: Dyspepsia/heartburn
|
7.8%
5/64 • Number of events 5
|
|
Gastrointestinal disorders
GASTROINTESTINAL:: Dysphagia, esophagitis, odynophagia (painful swallowing)
|
3.1%
2/64 • Number of events 2
|
|
Gastrointestinal disorders
GASTROINTESTINAL:: Gastrointestinal-Other (Specify, tongue discoloration)
|
1.6%
1/64 • Number of events 1
|
|
Gastrointestinal disorders
GASTROINTESTINAL:: Mouth dryness
|
1.6%
1/64 • Number of events 1
|
|
Gastrointestinal disorders
GASTROINTESTINAL:: Nausea
|
23.4%
15/64 • Number of events 21
|
|
Gastrointestinal disorders
GASTROINTESTINAL:: Taste disturbance (dysgeusia)
|
1.6%
1/64 • Number of events 1
|
|
Gastrointestinal disorders
GASTROINTESTINAL:: Vomiting
|
18.8%
12/64 • Number of events 15
|
|
Renal and urinary disorders
HEMORRHAGE:: Hematuria (in the absence of vaginal bleeding)
|
1.6%
1/64 • Number of events 1
|
|
Gastrointestinal disorders
HEMORRHAGE:: Rectal bleeding/hematochezia
|
1.6%
1/64 • Number of events 1
|
|
Hepatobiliary disorders
HEPATIC:: Alkaline phosphatase
|
18.8%
12/64 • Number of events 25
|
|
Hepatobiliary disorders
HEPATIC:: Bilirubin
|
18.8%
12/64 • Number of events 26
|
|
Hepatobiliary disorders
HEPATIC:: Hypoalbuminemia
|
48.4%
31/64 • Number of events 76
|
|
Hepatobiliary disorders
HEPATIC:: SGOT (AST) (serum glutamic oxaloacetic transaminase)
|
25.0%
16/64 • Number of events 33
|
|
Hepatobiliary disorders
HEPATIC:: SGPT (ALT) (serum glutamic pyruvic transaminase)
|
25.0%
16/64 • Number of events 23
|
|
Infections and infestations
INFECTION/FEBRILE NEUTROPENIA:: Catheter-related infection
|
1.6%
1/64 • Number of events 1
|
|
Infections and infestations
INFECTION/FEBRILE NEUTROPENIA:: Infection without neutropenia
|
17.2%
11/64 • Number of events 17
|
|
Metabolism and nutrition disorders
METABOLIC/LABORATORY:: Amylase
|
4.7%
3/64 • Number of events 3
|
|
Metabolism and nutrition disorders
METABOLIC/LABORATORY:: Bicarbonate
|
1.6%
1/64 • Number of events 1
|
|
Metabolism and nutrition disorders
METABOLIC/LABORATORY:: CPK (creatine phosphokinase)
|
9.4%
6/64 • Number of events 7
|
|
Metabolism and nutrition disorders
METABOLIC/LABORATORY:: Hypercalcemia
|
4.7%
3/64 • Number of events 5
|
|
Metabolism and nutrition disorders
METABOLIC/LABORATORY:: Hypercholesterolemia
|
9.4%
6/64 • Number of events 9
|
|
Metabolism and nutrition disorders
METABOLIC/LABORATORY:: Hyperglycemia
|
18.8%
12/64 • Number of events 19
|
|
Metabolism and nutrition disorders
METABOLIC/LABORATORY:: Hyperkalemia
|
7.8%
5/64 • Number of events 5
|
|
Metabolism and nutrition disorders
METABOLIC/LABORATORY:: Hypermagnesemia
|
10.9%
7/64 • Number of events 11
|
|
Metabolism and nutrition disorders
METABOLIC/LABORATORY:: Hypernatremia
|
4.7%
3/64 • Number of events 5
|
|
Metabolism and nutrition disorders
METABOLIC/LABORATORY:: Hypertriglyceridemia
|
4.7%
3/64 • Number of events 3
|
|
Metabolism and nutrition disorders
METABOLIC/LABORATORY:: Hyperuricemia
|
4.7%
3/64 • Number of events 4
|
|
Metabolism and nutrition disorders
METABOLIC/LABORATORY:: Hypocalcemia
|
18.8%
12/64 • Number of events 21
|
|
Metabolism and nutrition disorders
METABOLIC/LABORATORY:: Hypoglycemia
|
6.2%
4/64 • Number of events 4
|
|
Metabolism and nutrition disorders
METABOLIC/LABORATORY:: Hypokalemia
|
7.8%
5/64 • Number of events 7
|
|
Metabolism and nutrition disorders
METABOLIC/LABORATORY:: Hypomagnesemia
|
28.1%
18/64 • Number of events 31
|
|
Metabolism and nutrition disorders
METABOLIC/LABORATORY:: Hyponatremia
|
23.4%
15/64 • Number of events 25
|
|
Metabolism and nutrition disorders
METABOLIC/LABORATORY:: Hypophosphatemia
|
10.9%
7/64 • Number of events 16
|
|
Metabolism and nutrition disorders
METABOLIC/LABORATORY:: Lipase
|
3.1%
2/64 • Number of events 5
|
|
Metabolism and nutrition disorders
METABOLIC/LABORATORY:: Metabolic/Laboratory-Other (Specify, low zinc)
|
53.1%
34/64 • Number of events 58
|
|
Metabolism and nutrition disorders
METABOLIC/LABORATORY:: Metabolic/Laboratory-Other (Specify, low zinc serum)
|
6.2%
4/64 • Number of events 7
|
|
Metabolism and nutrition disorders
METABOLIC/LABORATORY:: Metabolic/Laboratory-Other (Specify, serum zinc)
|
1.6%
1/64 • Number of events 1
|
|
Metabolism and nutrition disorders
METABOLIC/LABORATORY:: Metabolic/Laboratory-Other (Specify, zinc)
|
6.2%
4/64 • Number of events 11
|
|
Metabolism and nutrition disorders
METABOLIC/LABORATORY:: Metabolic/Laboratory-Other (Specify, zinc, low)
|
1.6%
1/64 • Number of events 1
|
|
Metabolism and nutrition disorders
METABOLIC/LABORATORY:: Metabolic/Laboratory-Other (Specify, zinc-serum (low))
|
1.6%
1/64 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL:: Musculoskeletal-Other (Specify, Akathisia)
|
1.6%
1/64 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL:: Musculoskeletal-Other (Specify,muscle aches)
|
1.6%
1/64 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL:: Osteonecrosis (avascular necrosis)
|
1.6%
1/64 • Number of events 1
|
|
Nervous system disorders
NEUROLOGY:: Dizziness/lightheadedness
|
4.7%
3/64 • Number of events 3
|
|
Nervous system disorders
NEUROLOGY:: Insomnia
|
4.7%
3/64 • Number of events 3
|
|
Eye disorders
OCULAR/VISUAL:: Ocular/Visual-Other (Specify, transient vision lost)
|
1.6%
1/64 • Number of events 1
|
|
Gastrointestinal disorders
PAIN:: Abdominal pain or cramping
|
10.9%
7/64 • Number of events 8
|
|
Musculoskeletal and connective tissue disorders
PAIN:: Arthralgia (joint pain)
|
4.7%
3/64 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
PAIN:: Bone pain
|
7.8%
5/64 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
PAIN:: Chest pain (non-cardiac and non-pleuritic)
|
4.7%
3/64 • Number of events 3
|
|
Nervous system disorders
PAIN:: Headache
|
14.1%
9/64 • Number of events 13
|
|
Musculoskeletal and connective tissue disorders
PAIN:: Myalgia (muscle pain)
|
15.6%
10/64 • Number of events 16
|
|
General disorders
PAIN:: Pain-Other (Specify, ankle)
|
1.6%
1/64 • Number of events 1
|
|
General disorders
PAIN:: Pain-Other (Specify, Back)
|
1.6%
1/64 • Number of events 1
|
|
General disorders
PAIN:: Pain-Other (Specify, jaw pain/tightness)
|
1.6%
1/64 • Number of events 1
|
|
General disorders
PAIN:: Pain-Other (Specify, pain Lt axilla surgical site)
|
1.6%
1/64 • Number of events 1
|
|
General disorders
PAIN:: Pain-Other (Specify, pain: Back:sacral area)
|
1.6%
1/64 • Number of events 1
|
|
General disorders
PAIN:: Pain-Other (Specify, Rt shoulder pain)
|
1.6%
1/64 • Number of events 1
|
|
General disorders
PAIN:: Pain-Other (Specify, Rt great toe pain: ingrown toenail)
|
1.6%
1/64 • Number of events 1
|
|
General disorders
PAIN:: Pain-Other (Specify, Rt flank)
|
1.6%
1/64 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
PAIN:: Pleuritic pain
|
1.6%
1/64 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PAIN:: Tumor pain (onset or exacerbation of tumor pain due to treatment)
|
3.1%
2/64 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY:: Cough
|
12.5%
8/64 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY:: Dyspnea (shortness of breath)
|
4.7%
3/64 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY:: Hypoxia
|
3.1%
2/64 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY:: Pleural effusion (non-malignant)
|
3.1%
2/64 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY:: Pneumonitis/pulmonary infiltrates
|
1.6%
1/64 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY:: Pulmonary-Other (Specify, upper respiratory infection)
|
1.6%
1/64 • Number of events 1
|
|
Renal and urinary disorders
RENAL/GENITOURINARY:: Creatinine
|
6.2%
4/64 • Number of events 10
|
|
Renal and urinary disorders
RENAL/GENITOURINARY:: Dysuria (painful urination)
|
1.6%
1/64 • Number of events 1
|
|
Renal and urinary disorders
RENAL/GENITOURINARY:: Hemoglobinuria
|
3.1%
2/64 • Number of events 4
|
|
Renal and urinary disorders
RENAL/GENITOURINARY:: Proteinuria
|
1.6%
1/64 • Number of events 2
|
|
Renal and urinary disorders
RENAL/GENITOURINARY:: Renal/Genitourinary-Other (Specify, hesitancy)
|
1.6%
1/64 • Number of events 1
|
|
Reproductive system and breast disorders
SEXUAL/REPRODUCTIVE FUNCTION:: Irregular menses (change from baseline)
|
1.6%
1/64 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place