Trial Outcomes & Findings for Alemtuzumab (Campath) to Treat T-Large Granular Lymphocyte Leukemia (NCT NCT00345345)
NCT ID: NCT00345345
Last Updated: 2022-05-03
Results Overview
The primary endpoint was hematologic response at three months after treatment. A complete response (CR) was defined as normalization of all affected lineages, and a partial response (PR) was defined in neutropenic subjects as 100% increase in the ANC to \>500/µL, and in those with anemia, any increase in hemoglobin of 2 g/dL or more observed in at least two serial measurements 1 week apart and sustained for one month or more without exogenous growth factors support or transfusions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
29 participants
Primary outcome timeframe
3 months
Results posted on
2022-05-03
Participant Flow
Participant milestones
| Measure |
Alemtuzumab in Patients With T Cell Large Granular Lymphocytic Leukemia (T-LGL)
10 mg Alemtuzumab (Campath®; Genzyme) was administered intravenously daily for 10 days, after a 1 mg intravenous test dose.
|
|---|---|
|
Overall Study
STARTED
|
29
|
|
Overall Study
COMPLETED
|
27
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Alemtuzumab (Campath) to Treat T-Large Granular Lymphocyte Leukemia
Baseline characteristics by cohort
| Measure |
Alemtuzumab in Patients With T Cell Large Granular Lymphocytic Leukemia (T-LGL)
n=29 Participants
10 mg Alemtuzumab (Campath®; Genzyme) was administered intravenously daily for 10 days, after a 1 mg intravenous test dose.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 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
|
0 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
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: The analyses included only those subjects who were given Alemtuzumab. Analysis was by intention to treat.
The primary endpoint was hematologic response at three months after treatment. A complete response (CR) was defined as normalization of all affected lineages, and a partial response (PR) was defined in neutropenic subjects as 100% increase in the ANC to \>500/µL, and in those with anemia, any increase in hemoglobin of 2 g/dL or more observed in at least two serial measurements 1 week apart and sustained for one month or more without exogenous growth factors support or transfusions.
Outcome measures
| Measure |
Alemtuzumab in Patients With T Cell Large Granular Lymphocytic Leukemia (T-LGL)
n=29 Participants
10 mg Alemtuzumab (Campath®; Genzyme) was administered intravenously daily for 10 days, after a 1 mg intravenous test dose.
|
|---|---|
|
Number of Participants With Hematological Response After Three Months of Alemtuzumab
|
15 Participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Analysis was by intention to treat. One participant not evaluable, died prior to 3 months.
Number of participants that are red blood cell and/or platelet Transfusion-Independent following Alemtuzumab
Outcome measures
| Measure |
Alemtuzumab in Patients With T Cell Large Granular Lymphocytic Leukemia (T-LGL)
n=28 Participants
10 mg Alemtuzumab (Campath®; Genzyme) was administered intravenously daily for 10 days, after a 1 mg intravenous test dose.
|
|---|---|
|
Number of Participants That Are Red Blood Cell and/or Platelet Transfusion-Independent
Both red blood cell and platelet transfusion-independent
|
16 Participants
|
|
Number of Participants That Are Red Blood Cell and/or Platelet Transfusion-Independent
Either red blood cell or platelet transfusion-dependent
|
12 Participants
|
SECONDARY outcome
Timeframe: 3 monthsParticipants overall survival after Alemtuzumab infusion for cell large granular lymphocytic leukemia (T-LGL) at month 3.
Outcome measures
| Measure |
Alemtuzumab in Patients With T Cell Large Granular Lymphocytic Leukemia (T-LGL)
n=29 Participants
10 mg Alemtuzumab (Campath®; Genzyme) was administered intravenously daily for 10 days, after a 1 mg intravenous test dose.
|
|---|---|
|
Participants Overall Survival After Alemtuzumab Infusion
Alive
|
28 Participants
|
|
Participants Overall Survival After Alemtuzumab Infusion
Deceased
|
1 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Analysis was by intention to treat.
Number of participants that experienced a Life-Threatening Toxicity (grade \>/= 4) as defined by Common toxicity Criteria (CTC) version 2.0. The CTC 2.0 is a set of criteria for the standardized classification of adverse effects. Adverse events are graded accordingly: 0 = No adverse event or within normal limits 1 = Mild adverse event 2 = Moderate adverse event 3 = Severe and undesirable adverse event 4 = Life-threatening or disabling adverse event 5 = Death related to adverse event
Outcome measures
| Measure |
Alemtuzumab in Patients With T Cell Large Granular Lymphocytic Leukemia (T-LGL)
n=29 Participants
10 mg Alemtuzumab (Campath®; Genzyme) was administered intravenously daily for 10 days, after a 1 mg intravenous test dose.
|
|---|---|
|
Number of Participants That Experienced a Life-Threatening Toxicity
Platelet count decreased
|
2 Participants
|
|
Number of Participants That Experienced a Life-Threatening Toxicity
Lymphocyte count decreased
|
13 Participants
|
|
Number of Participants That Experienced a Life-Threatening Toxicity
White blood cell decreased
|
3 Participants
|
|
Number of Participants That Experienced a Life-Threatening Toxicity
Neutrophil count decreased
|
1 Participants
|
|
Number of Participants That Experienced a Life-Threatening Toxicity
Monocytes count decreased
|
1 Participants
|
SECONDARY outcome
Timeframe: Month 12Population: 10 participants were not evaluable
Number of participants that are Relapse-free survival following Campath infusion. Relapse is defined as a fall in peripheral blood counts to 50% the values obtained during the response period.
Outcome measures
| Measure |
Alemtuzumab in Patients With T Cell Large Granular Lymphocytic Leukemia (T-LGL)
n=19 Participants
10 mg Alemtuzumab (Campath®; Genzyme) was administered intravenously daily for 10 days, after a 1 mg intravenous test dose.
|
|---|---|
|
Number of Participants That Are Relapse-free Survival Following Campath Infusion.
|
10 Participants
|
SECONDARY outcome
Timeframe: Up to Month 12Population: Participants who completed molecular testing
Number of Participants with Molecular Response to Campath. Molecular Response to Campath is defined as disappearance of the clonal population of T-LGL
Outcome measures
| Measure |
Alemtuzumab in Patients With T Cell Large Granular Lymphocytic Leukemia (T-LGL)
n=21 Participants
10 mg Alemtuzumab (Campath®; Genzyme) was administered intravenously daily for 10 days, after a 1 mg intravenous test dose.
|
|---|---|
|
Number of Participants With Molecular Response to Campath
|
14 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 5 participants were not evaluable.
Participant response at 6 months following Alemtuzumab. A complete response (CR) was defined as normalization of all affected lineages, and a partial response (PR) was defined in neutropenic subjects as 100% increase in the ANC to \>500/µL, and in those with anemia, any increase in hemoglobin of 2 g/dL or more observed in at least two serial measurements 1 week apart and sustained for one month or more without exogenous growth factors support or transfusions.
Outcome measures
| Measure |
Alemtuzumab in Patients With T Cell Large Granular Lymphocytic Leukemia (T-LGL)
n=24 Participants
10 mg Alemtuzumab (Campath®; Genzyme) was administered intravenously daily for 10 days, after a 1 mg intravenous test dose.
|
|---|---|
|
Participant Response at 6 Months
Complete Response
|
10 Participants
|
|
Participant Response at 6 Months
No Response
|
5 Participants
|
|
Participant Response at 6 Months
Disease Relapse
|
4 Participants
|
|
Participant Response at 6 Months
Partial Response
|
5 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Participants that received a second cycle of Campath
Participants Response to a second cycle of Campath. A complete response (CR) was defined as normalization of all affected lineages, and a partial response (PR) was defined in neutropenic subjects as 100% increase in the ANC to \>500/µL, and in those with anemia, any increase in hemoglobin of 2 g/dL or more observed in at least two serial measurements 1 week apart and sustained for one month or more without exogenous growth factors support or transfusions.
Outcome measures
| Measure |
Alemtuzumab in Patients With T Cell Large Granular Lymphocytic Leukemia (T-LGL)
n=8 Participants
10 mg Alemtuzumab (Campath®; Genzyme) was administered intravenously daily for 10 days, after a 1 mg intravenous test dose.
|
|---|---|
|
Participants Response to a Second Cycle of Campath
No response
|
5 Participants
|
|
Participants Response to a Second Cycle of Campath
Relapsed
|
3 Participants
|
|
Participants Response to a Second Cycle of Campath
Complete Response
|
0 Participants
|
|
Participants Response to a Second Cycle of Campath
Partial Response
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 6 monthsPopulation: 3 participants were not evaluable as no data was collected.
Number of participants with clone size improvements following Alu
Outcome measures
| Measure |
Alemtuzumab in Patients With T Cell Large Granular Lymphocytic Leukemia (T-LGL)
n=26 Participants
10 mg Alemtuzumab (Campath®; Genzyme) was administered intravenously daily for 10 days, after a 1 mg intravenous test dose.
|
|---|---|
|
Number of Participants With Clone Size Improvements
Deceased in clone size
|
20 Participants
|
|
Number of Participants With Clone Size Improvements
No deceased in clone size
|
6 Participants
|
Adverse Events
Alemtuzumab in Patients With T Cell Large Granular Lymphocytic Leukemia (T-LGL)
Serious events: 13 serious events
Other events: 29 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Alemtuzumab in Patients With T Cell Large Granular Lymphocytic Leukemia (T-LGL)
n=29 participants at risk
10 mg Alemtuzumab (Campath®; Genzyme) was administered intravenously daily for 10 days, after a 1 mg intravenous test dose.
|
|---|---|
|
Blood and lymphatic system disorders
Acquired dysfibrinogenaemia
|
3.4%
1/29 • 12 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
17.2%
5/29 • 12 months
|
|
Cardiac disorders
Atrial fibrillation
|
3.4%
1/29 • 12 months
|
|
Gastrointestinal disorders
Autoimmune colitis
|
3.4%
1/29 • 12 months
|
|
Gastrointestinal disorders
Gastrointestinal hemorrhage
|
3.4%
1/29 • 12 months
|
|
General disorders
Injection site infection
|
3.4%
1/29 • 12 months
|
|
Infections and infestations
Bacterial infection
|
6.9%
2/29 • 12 months
|
|
Infections and infestations
Clostridium difficile infection
|
6.9%
2/29 • 12 months
|
|
Infections and infestations
Mycobacterial infection
|
3.4%
1/29 • 12 months
|
|
Infections and infestations
Pneumonia
|
3.4%
1/29 • 12 months
|
|
Infections and infestations
Sinusitis
|
3.4%
1/29 • 12 months
|
|
Investigations
Hemoglobin decreased
|
3.4%
1/29 • 12 months
|
|
Investigations
Transaminases increased
|
3.4%
1/29 • 12 months
|
|
Metabolism and nutrition disorders
Respiratory failure
|
3.4%
1/29 • 12 months
|
|
Surgical and medical procedures
Aortic aneurysm repair
|
3.4%
1/29 • 12 months
|
|
Surgical and medical procedures
Percutaneous coronary intervention
|
3.4%
1/29 • 12 months
|
Other adverse events
| Measure |
Alemtuzumab in Patients With T Cell Large Granular Lymphocytic Leukemia (T-LGL)
n=29 participants at risk
10 mg Alemtuzumab (Campath®; Genzyme) was administered intravenously daily for 10 days, after a 1 mg intravenous test dose.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
6.9%
2/29 • 12 months
|
|
Blood and lymphatic system disorders
Lymphopenia
|
3.4%
1/29 • 12 months
|
|
Blood and lymphatic system disorders
Petechiae
|
3.4%
1/29 • 12 months
|
|
Cardiac disorders
Arrhythmia
|
3.4%
1/29 • 12 months
|
|
Cardiac disorders
Atrial fibrillation
|
3.4%
1/29 • 12 months
|
|
Cardiac disorders
Chest discomfort
|
3.4%
1/29 • 12 months
|
|
Cardiac disorders
Chest pain
|
6.9%
2/29 • 12 months
|
|
Cardiac disorders
Dizziness
|
17.2%
5/29 • 12 months
|
|
Cardiac disorders
Dizziness postural
|
3.4%
1/29 • 12 months
|
|
Cardiac disorders
Dyspnea
|
17.2%
5/29 • 12 months
|
|
Cardiac disorders
Dyspnea exertional
|
6.9%
2/29 • 12 months
|
|
Cardiac disorders
Fluid overload
|
6.9%
2/29 • 12 months
|
|
Cardiac disorders
Palpitations
|
3.4%
1/29 • 12 months
|
|
Cardiac disorders
Peripheral swelling
|
3.4%
1/29 • 12 months
|
|
Cardiac disorders
Supraventricular tachycardia
|
3.4%
1/29 • 12 months
|
|
Ear and labyrinth disorders
Deafness
|
3.4%
1/29 • 12 months
|
|
Ear and labyrinth disorders
Ear infection
|
3.4%
1/29 • 12 months
|
|
Ear and labyrinth disorders
Ear pain
|
6.9%
2/29 • 12 months
|
|
Endocrine disorders
Hypothyroidism
|
3.4%
1/29 • 12 months
|
|
Eye disorders
Blepharitis
|
3.4%
1/29 • 12 months
|
|
Eye disorders
Conjunctivitis
|
3.4%
1/29 • 12 months
|
|
Eye disorders
Ophthalmic herpes simplex
|
3.4%
1/29 • 12 months
|
|
Eye disorders
Photopsia
|
3.4%
1/29 • 12 months
|
|
Eye disorders
Vision blurred
|
3.4%
1/29 • 12 months
|
|
Gastrointestinal disorders
Abdominal pain
|
10.3%
3/29 • 12 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.4%
1/29 • 12 months
|
|
Gastrointestinal disorders
Constipation
|
13.8%
4/29 • 12 months
|
|
Gastrointestinal disorders
Diarrhea
|
13.8%
4/29 • 12 months
|
|
Gastrointestinal disorders
Diverticulitis
|
6.9%
2/29 • 12 months
|
|
Gastrointestinal disorders
Dyspepsia
|
3.4%
1/29 • 12 months
|
|
Gastrointestinal disorders
Epigastric discomfort
|
6.9%
2/29 • 12 months
|
|
Gastrointestinal disorders
Eructation
|
3.4%
1/29 • 12 months
|
|
Gastrointestinal disorders
Gastroenteritis viral
|
3.4%
1/29 • 12 months
|
|
Gastrointestinal disorders
Mouth ulceration
|
6.9%
2/29 • 12 months
|
|
Gastrointestinal disorders
Nausea
|
31.0%
9/29 • 12 months
|
|
Gastrointestinal disorders
Oral herpes
|
3.4%
1/29 • 12 months
|
|
Gastrointestinal disorders
Oral pain
|
6.9%
2/29 • 12 months
|
|
Gastrointestinal disorders
Oropharyngeal candidiasis
|
3.4%
1/29 • 12 months
|
|
Gastrointestinal disorders
Oropharyngeal pain
|
6.9%
2/29 • 12 months
|
|
Gastrointestinal disorders
Toothache
|
3.4%
1/29 • 12 months
|
|
Gastrointestinal disorders
Vomiting
|
3.4%
1/29 • 12 months
|
|
General disorders
Asthenia
|
10.3%
3/29 • 12 months
|
|
General disorders
Chills
|
51.7%
15/29 • 12 months
|
|
General disorders
Crepitations
|
3.4%
1/29 • 12 months
|
|
General disorders
Decreased appetite
|
6.9%
2/29 • 12 months
|
|
General disorders
Facial pain
|
3.4%
1/29 • 12 months
|
|
General disorders
Fatigue
|
24.1%
7/29 • 12 months
|
|
General disorders
Feeling hot
|
3.4%
1/29 • 12 months
|
|
General disorders
Gait disturbance
|
3.4%
1/29 • 12 months
|
|
General disorders
Hyperhidrosis
|
6.9%
2/29 • 12 months
|
|
General disorders
Infusion related reaction
|
41.4%
12/29 • 12 months
|
|
General disorders
Injection site hemorrhage
|
10.3%
3/29 • 12 months
|
|
General disorders
Injection site pain
|
3.4%
1/29 • 12 months
|
|
General disorders
Malaise
|
3.4%
1/29 • 12 months
|
|
General disorders
Night sweats
|
6.9%
2/29 • 12 months
|
|
General disorders
Oedema
|
10.3%
3/29 • 12 months
|
|
General disorders
Peripheral coldness
|
3.4%
1/29 • 12 months
|
|
General disorders
Pyrexia
|
51.7%
15/29 • 12 months
|
|
General disorders
Swelling
|
3.4%
1/29 • 12 months
|
|
Hepatobiliary disorders
Cholelithiasis
|
3.4%
1/29 • 12 months
|
|
Immune system disorders
Drug hypersensitivity
|
3.4%
1/29 • 12 months
|
|
Immune system disorders
Urticaria
|
3.4%
1/29 • 12 months
|
|
Infections and infestations
Bacteremia
|
6.9%
2/29 • 12 months
|
|
Infections and infestations
Bronchitis
|
10.3%
3/29 • 12 months
|
|
Infections and infestations
Cellulitis
|
3.4%
1/29 • 12 months
|
|
Infections and infestations
Clostridium difficile infection
|
3.4%
1/29 • 12 months
|
|
Infections and infestations
Pharyngitis streptococcal
|
3.4%
1/29 • 12 months
|
|
Infections and infestations
Pneumonia
|
3.4%
1/29 • 12 months
|
|
Infections and infestations
Tinea infection
|
3.4%
1/29 • 12 months
|
|
Infections and infestations
Upper respiratory tract infection
|
10.3%
3/29 • 12 months
|
|
Infections and infestations
Urinary tract infection
|
6.9%
2/29 • 12 months
|
|
Infections and infestations
Vaginal infection
|
3.4%
1/29 • 12 months
|
|
Infections and infestations
Viral upper respiratory tract infection
|
3.4%
1/29 • 12 months
|
|
Injury, poisoning and procedural complications
Contusion
|
6.9%
2/29 • 12 months
|
|
Injury, poisoning and procedural complications
Iron overload
|
6.9%
2/29 • 12 months
|
|
Investigations
Alanine aminotransferase increased
|
10.3%
3/29 • 12 months
|
|
Investigations
Aspartate aminotransferase increased
|
3.4%
1/29 • 12 months
|
|
Investigations
Blood creatinine increased
|
6.9%
2/29 • 12 months
|
|
Investigations
Blood electrolytes decreased
|
3.4%
1/29 • 12 months
|
|
Investigations
Blood fibrinogen increased
|
3.4%
1/29 • 12 months
|
|
Investigations
Blood glucose increased
|
6.9%
2/29 • 12 months
|
|
Investigations
Blood iron decreased
|
3.4%
1/29 • 12 months
|
|
Investigations
Blood pressure decreased
|
6.9%
2/29 • 12 months
|
|
Investigations
Blood pressure increased
|
17.2%
5/29 • 12 months
|
|
Investigations
Blood thyroid stimulating hormone increased
|
10.3%
3/29 • 12 months
|
|
Investigations
Ejection fraction decreased
|
3.4%
1/29 • 12 months
|
|
Investigations
Heart rate decreased
|
3.4%
1/29 • 12 months
|
|
Investigations
Heart rate increased
|
3.4%
1/29 • 12 months
|
|
Investigations
Hepatic enzyme increased
|
17.2%
5/29 • 12 months
|
|
Investigations
Liver function test abnormal
|
6.9%
2/29 • 12 months
|
|
Investigations
Lymphocyte count decreased
|
86.2%
25/29 • 12 months
|
|
Investigations
Monocyte count decreased
|
3.4%
1/29 • 12 months
|
|
Investigations
Neutrophil count decreased
|
13.8%
4/29 • 12 months
|
|
Investigations
Oxygen saturation decreased
|
10.3%
3/29 • 12 months
|
|
Investigations
Platelet count decreased
|
6.9%
2/29 • 12 months
|
|
Investigations
Prothrombin time prolonged
|
10.3%
3/29 • 12 months
|
|
Investigations
Transaminases increased
|
3.4%
1/29 • 12 months
|
|
Investigations
Troponin increased
|
3.4%
1/29 • 12 months
|
|
Investigations
Weight decreased
|
3.4%
1/29 • 12 months
|
|
Investigations
Weight increased
|
3.4%
1/29 • 12 months
|
|
Investigations
White blood cell counts decreased
|
20.7%
6/29 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.4%
1/29 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
3.4%
1/29 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
3.4%
1/29 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
3.4%
1/29 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
3.4%
1/29 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.4%
1/29 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
3.4%
1/29 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Restless legs syndrome
|
3.4%
1/29 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Sciatica
|
3.4%
1/29 • 12 months
|
|
Nervous system disorders
Confusional state
|
3.4%
1/29 • 12 months
|
|
Nervous system disorders
Headache
|
31.0%
9/29 • 12 months
|
|
Nervous system disorders
Hypoaesthesia
|
3.4%
1/29 • 12 months
|
|
Nervous system disorders
Neuropathy peripheral
|
3.4%
1/29 • 12 months
|
|
Psychiatric disorders
Anxiety
|
3.4%
1/29 • 12 months
|
|
Psychiatric disorders
Depression
|
3.4%
1/29 • 12 months
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
3.4%
1/29 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
24.1%
7/29 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.9%
2/29 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.4%
1/29 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
3.4%
1/29 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
10.3%
3/29 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
3.4%
1/29 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus discomfort
|
3.4%
1/29 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
3.4%
1/29 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
3.4%
1/29 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
13.8%
4/29 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
3.4%
1/29 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
3.4%
1/29 • 12 months
|
|
Skin and subcutaneous tissue disorders
Acne
|
3.4%
1/29 • 12 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.4%
1/29 • 12 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
3.4%
1/29 • 12 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.4%
1/29 • 12 months
|
|
Skin and subcutaneous tissue disorders
Erythema
|
3.4%
1/29 • 12 months
|
|
Skin and subcutaneous tissue disorders
Palmoplantar keratoderma
|
3.4%
1/29 • 12 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.9%
2/29 • 12 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
20.7%
6/29 • 12 months
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
13.8%
4/29 • 12 months
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
3.4%
1/29 • 12 months
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
3.4%
1/29 • 12 months
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
3.4%
1/29 • 12 months
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
3.4%
1/29 • 12 months
|
|
Vascular disorders
Hypotension
|
17.2%
5/29 • 12 months
|
|
Vascular disorders
Thrombophlebitis
|
3.4%
1/29 • 12 months
|
Additional Information
Stefan F Cordes, Principal Investigator, M.D., Ph.D.
National Heart Lung and Blood Institute
Phone: +1 240 383 6460
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place