Trial Outcomes & Findings for Lenalidomide and Rituximab in Treating Patients With Previously Untreated Stage II, Stage III, or Stage IV Follicular Non-Hodgkin Lymphoma (NCT NCT01145495)
NCT ID: NCT01145495
Last Updated: 2023-06-27
Results Overview
Response is assessed by investigator according to International Working Group (IWG) criteria. Complete response requires disappearance of all evidence of disease.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
66 participants
Primary outcome timeframe
At 12 months
Results posted on
2023-06-27
Participant Flow
Between June 2010 and November 2011, 66 participants were recruited.
One participant did not receive protocol treatment and were dropped from all analyses.
Participant milestones
| Measure |
Treatment (Lenalidomide, Rituximab)
Patients receive oral lenalidomide (20mg) once daily on days 1-21. Treatment with lenalidomide repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Patients also receive rituximab (375mg/m\^2) IV in weeks 1, 2, 3, 4, 12, 20, 28, and 36 in the absence of disease progression or unacceptable toxicity.\> \>\>
\>
\>\> rituximab: Given IV\>
\>\>
\>
\>\> lenalidomide: Given orally
|
|---|---|
|
Overall Study
STARTED
|
65
|
|
Overall Study
COMPLETED
|
51
|
|
Overall Study
NOT COMPLETED
|
14
|
Reasons for withdrawal
| Measure |
Treatment (Lenalidomide, Rituximab)
Patients receive oral lenalidomide (20mg) once daily on days 1-21. Treatment with lenalidomide repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Patients also receive rituximab (375mg/m\^2) IV in weeks 1, 2, 3, 4, 12, 20, 28, and 36 in the absence of disease progression or unacceptable toxicity.\> \>\>
\>
\>\> rituximab: Given IV\>
\>\>
\>
\>\> lenalidomide: Given orally
|
|---|---|
|
Overall Study
Adverse Event
|
6
|
|
Overall Study
Withdrawal by Subject
|
6
|
|
Overall Study
Disease progression after respone
|
2
|
Baseline Characteristics
Lenalidomide and Rituximab in Treating Patients With Previously Untreated Stage II, Stage III, or Stage IV Follicular Non-Hodgkin Lymphoma
Baseline characteristics by cohort
| Measure |
Treatment (Lenalidomide, Rituximab)
n=66 Participants
Patients receive oral lenalidomide (20mg) once daily on days 1-21. Treatment with lenalidomide repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Patients also receive rituximab (375mg/m\^2) IV in weeks 1, 2, 3, 4, 12, 20, 28, and 36 in the absence of disease progression or unacceptable toxicity.\> \> rituximab: Given IV\>
\> lenalidomide: Given orally
|
|---|---|
|
Age, Continuous
|
53 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
66 participants
n=99 Participants
|
|
Follicular Lymphoma International Prognostic Index (FLIPI)
0-1
|
21 participants
n=99 Participants
|
|
Follicular Lymphoma International Prognostic Index (FLIPI)
2
|
43 participants
n=99 Participants
|
|
Follicular Lymphoma International Prognostic Index (FLIPI)
3
|
2 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: At 12 monthsResponse is assessed by investigator according to International Working Group (IWG) criteria. Complete response requires disappearance of all evidence of disease.
Outcome measures
| Measure |
Treatment (Lenalidomide, Rituximab)
n=65 Participants
Patients receive oral lenalidomide (20mg) once daily on days 1-21. Treatment with lenalidomide repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Patients also receive rituximab (375mg/m\^2) IV in weeks 1, 2, 3, 4, 12, 20, 28, and 36 in the absence of disease progression or unacceptable toxicity.\> \> rituximab: Given IV\>
\> lenalidomide: Given orally
|
|---|---|
|
Number of Participants Who Achieved a Complete Response
|
47 Participants
|
SECONDARY outcome
Timeframe: Up to 5 yearsData will be summarized using frequency tables.
Outcome measures
| Measure |
Treatment (Lenalidomide, Rituximab)
n=65 Participants
Patients receive oral lenalidomide (20mg) once daily on days 1-21. Treatment with lenalidomide repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Patients also receive rituximab (375mg/m\^2) IV in weeks 1, 2, 3, 4, 12, 20, 28, and 36 in the absence of disease progression or unacceptable toxicity.\> \> rituximab: Given IV\>
\> lenalidomide: Given orally
|
|---|---|
|
Toxicity of Study Treatment, Assessed by the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Grade 1-2 Fatigue
|
51 Participants
|
|
Toxicity of Study Treatment, Assessed by the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Grade 1-2 Rash
|
21 Participants
|
|
Toxicity of Study Treatment, Assessed by the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Grade 1-2 Febrile neutropenia
|
1 Participants
|
|
Toxicity of Study Treatment, Assessed by the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Grade 1-2 Diarrhea
|
24 Participants
|
|
Toxicity of Study Treatment, Assessed by the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Grade 3-4 Neutropenia
|
14 Participants
|
|
Toxicity of Study Treatment, Assessed by the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Grade 3-4 Lymphopenia
|
6 Participants
|
|
Toxicity of Study Treatment, Assessed by the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Grade 3-4 Thrombocytopenia
|
1 Participants
|
|
Toxicity of Study Treatment, Assessed by the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Grade 3-4 Infection
|
7 Participants
|
|
Toxicity of Study Treatment, Assessed by the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Grade 3-4 Rash
|
5 Participants
|
SECONDARY outcome
Timeframe: Up to 5 yearsKaplan-Meier method will be used. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Treatment (Lenalidomide, Rituximab)
n=65 Participants
Patients receive oral lenalidomide (20mg) once daily on days 1-21. Treatment with lenalidomide repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Patients also receive rituximab (375mg/m\^2) IV in weeks 1, 2, 3, 4, 12, 20, 28, and 36 in the absence of disease progression or unacceptable toxicity.\> \> rituximab: Given IV\>
\> lenalidomide: Given orally
|
|---|---|
|
Disease Progression
2 Years PFS
|
0.86 proportion of participants
Interval 0.75 to 0.93
|
|
Disease Progression
3 Years PFS
|
0.81 proportion of participants
Interval 0.69 to 0.89
|
|
Disease Progression
4 Years PFS
|
0.74 proportion of participants
Interval 0.61 to 0.86
|
|
Disease Progression
5 Years PFS
|
0.72 proportion of participants
Interval 0.58 to 0.82
|
SECONDARY outcome
Timeframe: Up to 5 yearsPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Treatment (Lenalidomide, Rituximab)
n=65 Participants
Patients receive oral lenalidomide (20mg) once daily on days 1-21. Treatment with lenalidomide repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Patients also receive rituximab (375mg/m\^2) IV in weeks 1, 2, 3, 4, 12, 20, 28, and 36 in the absence of disease progression or unacceptable toxicity.\> \> rituximab: Given IV\>
\> lenalidomide: Given orally
|
|---|---|
|
Best Response
CR
|
47 Participants
|
|
Best Response
PR
|
15 Participants
|
|
Best Response
SD
|
1 Participants
|
|
Best Response
Not evaluated
|
2 Participants
|
Adverse Events
Treatment (Lenalidomide, Rituximab)
Serious events: 0 serious events
Other events: 65 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment (Lenalidomide, Rituximab)
n=65 participants at risk
lenalidomide: Given orally
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
40.0%
26/65 • Number of events 92
|
|
Blood and lymphatic system disorders
Blood and lymph sys disorders - Oth Spec
|
6.2%
4/65 • Number of events 4
|
|
Blood and lymphatic system disorders
Leukocytosis
|
3.1%
2/65 • Number of events 2
|
|
Cardiac disorders
Atrial fibrillation
|
1.5%
1/65 • Number of events 2
|
|
Cardiac disorders
Chest pain - cardiac
|
4.6%
3/65 • Number of events 6
|
|
Cardiac disorders
Palpitations
|
1.5%
1/65 • Number of events 2
|
|
Cardiac disorders
Sinus bradycardia
|
7.7%
5/65 • Number of events 16
|
|
Cardiac disorders
Sinus tachycardia
|
1.5%
1/65 • Number of events 5
|
|
Ear and labyrinth disorders
Ear pain
|
1.5%
1/65 • Number of events 3
|
|
Ear and labyrinth disorders
Vertigo
|
1.5%
1/65 • Number of events 1
|
|
Endocrine disorders
Hyperthyroidism
|
1.5%
1/65 • Number of events 1
|
|
Endocrine disorders
Hypothyroidism
|
4.6%
3/65 • Number of events 3
|
|
Eye disorders
Blurred vision
|
4.6%
3/65 • Number of events 3
|
|
Eye disorders
Dry eye
|
1.5%
1/65 • Number of events 2
|
|
Eye disorders
Extraocular muscle paresis
|
1.5%
1/65 • Number of events 1
|
|
Eye disorders
Photophobia
|
1.5%
1/65 • Number of events 1
|
|
Eye disorders
Watering eyes
|
1.5%
1/65 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal distension
|
1.5%
1/65 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
20.0%
13/65 • Number of events 36
|
|
Gastrointestinal disorders
Bloating
|
6.2%
4/65 • Number of events 4
|
|
Gastrointestinal disorders
Constipation
|
29.2%
19/65 • Number of events 68
|
|
Gastrointestinal disorders
Diarrhea
|
44.6%
29/65 • Number of events 59
|
|
Gastrointestinal disorders
Dry mouth
|
3.1%
2/65 • Number of events 2
|
|
Gastrointestinal disorders
Dyspepsia
|
16.9%
11/65 • Number of events 29
|
|
Gastrointestinal disorders
Dysphagia
|
1.5%
1/65 • Number of events 3
|
|
Gastrointestinal disorders
Enterocolitis
|
3.1%
2/65 • Number of events 2
|
|
Gastrointestinal disorders
Gastritis
|
1.5%
1/65 • Number of events 1
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
9.2%
6/65 • Number of events 9
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Oth spec
|
4.6%
3/65 • Number of events 8
|
|
Gastrointestinal disorders
Ileal perforation
|
1.5%
1/65 • Number of events 1
|
|
Gastrointestinal disorders
Lip pain
|
1.5%
1/65 • Number of events 1
|
|
Gastrointestinal disorders
Mucositis oral
|
12.3%
8/65 • Number of events 19
|
|
Gastrointestinal disorders
Nausea
|
29.2%
19/65 • Number of events 48
|
|
Gastrointestinal disorders
Oral hemorrhage
|
1.5%
1/65 • Number of events 1
|
|
Gastrointestinal disorders
Stomach pain
|
4.6%
3/65 • Number of events 3
|
|
Gastrointestinal disorders
Toothache
|
1.5%
1/65 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
9.2%
6/65 • Number of events 12
|
|
General disorders
Chills
|
12.3%
8/65 • Number of events 17
|
|
General disorders
Edema face
|
1.5%
1/65 • Number of events 1
|
|
General disorders
Edema limbs
|
24.6%
16/65 • Number of events 50
|
|
General disorders
Facial pain
|
1.5%
1/65 • Number of events 1
|
|
General disorders
Fatigue
|
86.2%
56/65 • Number of events 297
|
|
General disorders
Fever
|
12.3%
8/65 • Number of events 9
|
|
General disorders
Flu like symptoms
|
4.6%
3/65 • Number of events 3
|
|
General disorders
Gen disord and admin site conds-Oth spec
|
1.5%
1/65 • Number of events 1
|
|
General disorders
Localized edema
|
1.5%
1/65 • Number of events 4
|
|
General disorders
Non-cardiac chest pain
|
6.2%
4/65 • Number of events 11
|
|
General disorders
Pain
|
20.0%
13/65 • Number of events 38
|
|
Immune system disorders
Allergic reaction
|
10.8%
7/65 • Number of events 14
|
|
Immune system disorders
Cytokine release syndrome
|
4.6%
3/65 • Number of events 3
|
|
Immune system disorders
Serum sickness
|
1.5%
1/65 • Number of events 1
|
|
Infections and infestations
Conjunctivitis
|
3.1%
2/65 • Number of events 2
|
|
Infections and infestations
Gum infection
|
1.5%
1/65 • Number of events 2
|
|
Infections and infestations
Infections and infestations - Oth spec
|
6.2%
4/65 • Number of events 4
|
|
Infections and infestations
Lip infection
|
1.5%
1/65 • Number of events 1
|
|
Infections and infestations
Lung infection
|
1.5%
1/65 • Number of events 1
|
|
Infections and infestations
Mucosal infection
|
1.5%
1/65 • Number of events 1
|
|
Infections and infestations
Otitis media
|
1.5%
1/65 • Number of events 2
|
|
Infections and infestations
Rash pustular
|
3.1%
2/65 • Number of events 3
|
|
Infections and infestations
Sinusitis
|
9.2%
6/65 • Number of events 11
|
|
Infections and infestations
Skin infection
|
6.2%
4/65 • Number of events 9
|
|
Infections and infestations
Soft tissue infection
|
1.5%
1/65 • Number of events 2
|
|
Infections and infestations
Tooth infection
|
3.1%
2/65 • Number of events 2
|
|
Infections and infestations
Upper respiratory infection
|
21.5%
14/65 • Number of events 20
|
|
Infections and infestations
Urinary tract infection
|
7.7%
5/65 • Number of events 6
|
|
Infections and infestations
Vaginal infection
|
3.1%
2/65 • Number of events 2
|
|
Injury, poisoning and procedural complications
Bruising
|
6.2%
4/65 • Number of events 10
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
38.5%
25/65 • Number of events 31
|
|
Investigations
Activated partial throm time prolonged
|
1.5%
1/65 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
46.2%
30/65 • Number of events 98
|
|
Investigations
Alkaline phosphatase increased
|
21.5%
14/65 • Number of events 38
|
|
Investigations
Aspartate aminotransferase increased
|
33.8%
22/65 • Number of events 55
|
|
Investigations
Blood bilirubin increased
|
16.9%
11/65 • Number of events 22
|
|
Investigations
CD4 lymphocytes decreased
|
1.5%
1/65 • Number of events 1
|
|
Investigations
CO diffusing capacity decreased
|
1.5%
1/65 • Number of events 1
|
|
Investigations
Cholesterol high
|
3.1%
2/65 • Number of events 2
|
|
Investigations
Creatinine increased
|
9.2%
6/65 • Number of events 13
|
|
Investigations
Hemoglobin increased
|
3.1%
2/65 • Number of events 3
|
|
Investigations
INR increased
|
1.5%
1/65 • Number of events 1
|
|
Investigations
Lymphocyte count decreased
|
70.8%
46/65 • Number of events 186
|
|
Investigations
Neutrophil count decreased
|
55.4%
36/65 • Number of events 174
|
|
Investigations
Platelet count decreased
|
46.2%
30/65 • Number of events 133
|
|
Investigations
Weight gain
|
3.1%
2/65 • Number of events 10
|
|
Investigations
Weight loss
|
9.2%
6/65 • Number of events 20
|
|
Investigations
White blood cell decreased
|
63.1%
41/65 • Number of events 229
|
|
Metabolism and nutrition disorders
Acidosis
|
1.5%
1/65 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia
|
12.3%
8/65 • Number of events 11
|
|
Metabolism and nutrition disorders
Dehydration
|
1.5%
1/65 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
3.1%
2/65 • Number of events 12
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
44.6%
29/65 • Number of events 122
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
7.7%
5/65 • Number of events 5
|
|
Metabolism and nutrition disorders
Hypernatremia
|
4.6%
3/65 • Number of events 5
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
4.6%
3/65 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
12.3%
8/65 • Number of events 26
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
24.6%
16/65 • Number of events 35
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
13.8%
9/65 • Number of events 21
|
|
Metabolism and nutrition disorders
Hypokalemia
|
16.9%
11/65 • Number of events 21
|
|
Metabolism and nutrition disorders
Hyponatremia
|
10.8%
7/65 • Number of events 19
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
12.3%
8/65 • Number of events 31
|
|
Metabolism and nutrition disorders
Metabolism, nutrition disord - Oth spec
|
3.1%
2/65 • Number of events 3
|
|
Metabolism and nutrition disorders
Obesity
|
4.6%
3/65 • Number of events 24
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
3.1%
2/65 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
21.5%
14/65 • Number of events 41
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
3.1%
2/65 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.4%
10/65 • Number of events 35
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
4.6%
3/65 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
3.1%
2/65 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
1.5%
1/65 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
6.2%
4/65 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
1.5%
1/65 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
1.5%
1/65 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal, conn tissue - Oth spec
|
7.7%
5/65 • Number of events 20
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
18.5%
12/65 • Number of events 24
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
13.8%
9/65 • Number of events 19
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
13.8%
9/65 • Number of events 18
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
1.5%
1/65 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
10.8%
7/65 • Number of events 7
|
|
Nervous system disorders
Dysgeusia
|
9.2%
6/65 • Number of events 6
|
|
Nervous system disorders
Extrapyramidal disorder
|
1.5%
1/65 • Number of events 1
|
|
Nervous system disorders
Headache
|
23.1%
15/65 • Number of events 30
|
|
Nervous system disorders
Intracranial hemorrhage
|
1.5%
1/65 • Number of events 1
|
|
Nervous system disorders
Memory impairment
|
3.1%
2/65 • Number of events 2
|
|
Nervous system disorders
Paresthesia
|
4.6%
3/65 • Number of events 4
|
|
Nervous system disorders
Peripheral motor neuropathy
|
1.5%
1/65 • Number of events 2
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
20.0%
13/65 • Number of events 29
|
|
Nervous system disorders
Spasticity
|
1.5%
1/65 • Number of events 1
|
|
Nervous system disorders
Tremor
|
4.6%
3/65 • Number of events 8
|
|
Nervous system disorders
Vasovagal reaction
|
1.5%
1/65 • Number of events 1
|
|
Psychiatric disorders
Agitation
|
1.5%
1/65 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
18.5%
12/65 • Number of events 37
|
|
Psychiatric disorders
Confusion
|
3.1%
2/65 • Number of events 2
|
|
Psychiatric disorders
Depression
|
9.2%
6/65 • Number of events 21
|
|
Psychiatric disorders
Insomnia
|
18.5%
12/65 • Number of events 32
|
|
Psychiatric disorders
Libido decreased
|
3.1%
2/65 • Number of events 2
|
|
Psychiatric disorders
Restlessness
|
1.5%
1/65 • Number of events 1
|
|
Renal and urinary disorders
Acute kidney injury
|
1.5%
1/65 • Number of events 2
|
|
Renal and urinary disorders
Cystitis noninfective
|
1.5%
1/65 • Number of events 2
|
|
Renal and urinary disorders
Hematuria
|
1.5%
1/65 • Number of events 1
|
|
Renal and urinary disorders
Proteinuria
|
1.5%
1/65 • Number of events 1
|
|
Renal and urinary disorders
Renal and urinary disorders - Oth spec
|
3.1%
2/65 • Number of events 3
|
|
Renal and urinary disorders
Urinary frequency
|
4.6%
3/65 • Number of events 4
|
|
Renal and urinary disorders
Urinary retention
|
1.5%
1/65 • Number of events 1
|
|
Renal and urinary disorders
Urinary tract obstruction
|
1.5%
1/65 • Number of events 1
|
|
Renal and urinary disorders
Urinary tract pain
|
1.5%
1/65 • Number of events 1
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
1.5%
1/65 • Number of events 1
|
|
Reproductive system and breast disorders
Pelvic pain
|
1.5%
1/65 • Number of events 1
|
|
Reproductive system and breast disorders
Penile pain
|
1.5%
1/65 • Number of events 1
|
|
Reproductive system and breast disorders
Reproductive system and breast -Oth spec
|
1.5%
1/65 • Number of events 2
|
|
Reproductive system and breast disorders
Vaginal dryness
|
1.5%
1/65 • Number of events 1
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
3.1%
2/65 • Number of events 2
|
|
Reproductive system and breast disorders
Vaginal inflammation
|
1.5%
1/65 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
6.2%
4/65 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
1.5%
1/65 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.5%
12/65 • Number of events 36
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
18.5%
12/65 • Number of events 30
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
1.5%
1/65 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
9.2%
6/65 • Number of events 14
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
3.1%
2/65 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
1.5%
1/65 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
1.5%
1/65 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
1.5%
1/65 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
1.5%
1/65 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
1.5%
1/65 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
3.1%
2/65 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
1.5%
1/65 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.5%
1/65 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
13.8%
9/65 • Number of events 16
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
3.1%
2/65 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
9.2%
6/65 • Number of events 21
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrm
|
1.5%
1/65 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
20.0%
13/65 • Number of events 23
|
|
Skin and subcutaneous tissue disorders
Purpura
|
1.5%
1/65 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
4.6%
3/65 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
47.7%
31/65 • Number of events 76
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
1.5%
1/65 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin and subcut tissue disord - Oth spec
|
15.4%
10/65 • Number of events 21
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
1.5%
1/65 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.5%
1/65 • Number of events 1
|
|
Vascular disorders
Flushing
|
3.1%
2/65 • Number of events 2
|
|
Vascular disorders
Hematoma
|
1.5%
1/65 • Number of events 1
|
|
Vascular disorders
Hot flashes
|
4.6%
3/65 • Number of events 4
|
|
Vascular disorders
Hypertension
|
18.5%
12/65 • Number of events 50
|
|
Vascular disorders
Hypotension
|
1.5%
1/65 • Number of events 1
|
|
Vascular disorders
Phlebitis
|
3.1%
2/65 • Number of events 2
|
|
Vascular disorders
Thromboembolic event
|
4.6%
3/65 • Number of events 4
|
|
Vascular disorders
Vasculitis
|
1.5%
1/65 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60