Trial Outcomes & Findings for Phase II Study Alimta and Gemzar + Avastin as First Line Chemotherapy for Elderly Patients With Stage IIIB/IV NSCLC (NCT NCT00517595)
NCT ID: NCT00517595
Last Updated: 2012-03-12
Results Overview
PFS is defined as the duration of time from start of treatment to time of progression or death, whichever comes first. Progression is defined per RECIST criteria v1.0 as a measurable increase in the smallest diameter of any target lesion, progression of existing non-target lesions, or the appearance of 1 or more new lesions. The median progression free survival is the parameter used to describe PFS.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
48 participants
Primary outcome timeframe
PFS was measured from day 1 of treatment until time of progression (assessed every 8 weeks) or death, whichever came first, assessed up to 15 months.
Results posted on
2012-03-12
Participant Flow
9 community oncology research sites across the US within the ACORN network participated in this study. Enrollment started in August 2007 and was completed in September 2009.
Informed consent was obtained from all subjects. All subjects underwent screening procedures to verify eligibility.
Participant milestones
| Measure |
Pemetrexed, Gemcitabine, and Bevacizumab
All subjects received treatment with pemetrexed 500 mg/m\^2, gemcitabine 1500 mg/m\^2, and bevacizumab 10 mg/kg every 2 weeks.
|
|---|---|
|
Overall Study
STARTED
|
48
|
|
Overall Study
COMPLETED
|
48
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase II Study Alimta and Gemzar + Avastin as First Line Chemotherapy for Elderly Patients With Stage IIIB/IV NSCLC
Baseline characteristics by cohort
| Measure |
Pemetrexed, Gemcitabine, and Bevacizumab
n=48 Participants
All subjects received treatment with pemetrexed 500 mg/m\^2, gemcitabine 1500 mg/m\^2, and bevacizumab 10 mg/kg every 2 weeks.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
48 Participants
n=93 Participants
|
|
Age Continuous
|
72.60 years
STANDARD_DEVIATION 5.20 • n=93 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
48 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: PFS was measured from day 1 of treatment until time of progression (assessed every 8 weeks) or death, whichever came first, assessed up to 15 months.PFS is defined as the duration of time from start of treatment to time of progression or death, whichever comes first. Progression is defined per RECIST criteria v1.0 as a measurable increase in the smallest diameter of any target lesion, progression of existing non-target lesions, or the appearance of 1 or more new lesions. The median progression free survival is the parameter used to describe PFS.
Outcome measures
| Measure |
Pemetrexed, Gemcitabine, and Bevacizumab
n=48 Participants
All subjects received treatment with pemetrexed 500 mg/m\^2, gemcitabine 1500 mg/m\^2, and bevacizumab 10 mg/kg every 2 weeks.
|
|---|---|
|
Progression Free Survival (PFS)
|
4.90 Months
Interval 3.82 to 5.76
|
SECONDARY outcome
Timeframe: TTP was measured from day 1 of treatment until time of progression (assessed every 8 weeks), assessed up to 15 months.Time to progression is defined as the time from treatment start until objective tumor progression. Progression is defined per RECIST criteria v1.0 as a measurable increase in the smallest diameter of any target lesion, progression of existing non-target lesions, or the appearance of 1 or more new lesions. The median time to progression is the parameter used to describe TTP.
Outcome measures
| Measure |
Pemetrexed, Gemcitabine, and Bevacizumab
n=48 Participants
All subjects received treatment with pemetrexed 500 mg/m\^2, gemcitabine 1500 mg/m\^2, and bevacizumab 10 mg/kg every 2 weeks.
|
|---|---|
|
Time to Progression (TTP)
|
5.56 Months
Interval 4.61 to 7.57
|
SECONDARY outcome
Timeframe: OS was measured from day 1 of treatment until time of death, assessed up to 20 months.Overall survival is defined as the time from treatment start until death from any cause. The median overall survival time is used to measure OS.
Outcome measures
| Measure |
Pemetrexed, Gemcitabine, and Bevacizumab
n=48 Participants
All subjects received treatment with pemetrexed 500 mg/m\^2, gemcitabine 1500 mg/m\^2, and bevacizumab 10 mg/kg every 2 weeks.
|
|---|---|
|
Overall Survival (OS)
|
8.78 Months
Interval 6.71 to 19.9
|
SECONDARY outcome
Timeframe: Response to treatment was assessed after every 8 weeks of treatment, up to 50 weeks.Response was evaluated via changes from baseline in radiological tumor measurements performed after every 4th treatment cycle and at the end of treatment or time of progression. Response was evaluated using RECIST version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD) is neither sufficient shrinkage in sum of LD of target lesions to be PR nor increase of \>=20%; Progressive Disease (PD) is the increase in existing lesions or new lesions.
Outcome measures
| Measure |
Pemetrexed, Gemcitabine, and Bevacizumab
n=48 Participants
All subjects received treatment with pemetrexed 500 mg/m\^2, gemcitabine 1500 mg/m\^2, and bevacizumab 10 mg/kg every 2 weeks.
|
|---|---|
|
Overall Response
Complete response (CR)
|
0 Participants
|
|
Overall Response
Partial response (PR)
|
17 Participants
|
|
Overall Response
Stable disease (SD)
|
21 Participants
|
|
Overall Response
Progressive disease (PD)
|
6 Participants
|
|
Overall Response
Not evaluable (NE)
|
4 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: PFS was measured from day 1 of treatment until time of progression (assessed every 8 weeks) or death, whichever came first, assessed up to 15 months.Population: Note that N=18 patients for the Baseline ECOG performance status 0 group, and N=30 patients for the Baseline ECOG performance status 1 group.
PFS is defined as the duration of time from start of treatment to time of progression or death, whichever comes first. The median progression free survival is the parameter used to describe PFS. ECOG performance status describes how daily living activities of the patient are affected by disease. ECOG of 0 means the patient is fully active without restriction. ECOG of 1 means the patient is restricted in physically strenuous activity but is able to carry out light work. The investigator assigned the ECOG score at baseline (i.e., before the patient started study treatment).
Outcome measures
| Measure |
Pemetrexed, Gemcitabine, and Bevacizumab
n=48 Participants
All subjects received treatment with pemetrexed 500 mg/m\^2, gemcitabine 1500 mg/m\^2, and bevacizumab 10 mg/kg every 2 weeks.
|
|---|---|
|
Progression Free Survival (PFS) by Baseline Eastern Cooperative Oncology Group (ECOG) Performance Status
Baseline ECOG performance status 0 (N=18)
|
7.57 Months
Interval 2.01 to 9.44
|
|
Progression Free Survival (PFS) by Baseline Eastern Cooperative Oncology Group (ECOG) Performance Status
Baseline ECOG performance status 1 (N=30)
|
4.67 Months
Interval 3.68 to 5.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: OS was measured from day 1 of treatment until time of death, assessed up to 20 months.Population: Note that N=18 patients for the Baseline ECOG performance status 0 group, and N=30 patients for the Baseline ECOG performance status 1 group.
Overall survival is defined as the time from treatment start until death from any cause. The median overall survival time is used to measure OS. ECOG performance status describes how daily living activities of the patient are affected by disease. ECOG of 0 means the patient is fully active without restriction. ECOG of 1 means the patient is restricted in physically strenuous activity but is able to carry out light work. The investigator assigned the ECOG score at baseline (i.e., before the patient started study treatment).
Outcome measures
| Measure |
Pemetrexed, Gemcitabine, and Bevacizumab
n=48 Participants
All subjects received treatment with pemetrexed 500 mg/m\^2, gemcitabine 1500 mg/m\^2, and bevacizumab 10 mg/kg every 2 weeks.
|
|---|---|
|
Overall Survival (OS) by Baseline Eastern Cooperative Oncology Group (ECOG) Performance Status
Baseline ECOG performance status 0 (N=18)
|
19.87 Months
Interval 4.9 to 19.9
|
|
Overall Survival (OS) by Baseline Eastern Cooperative Oncology Group (ECOG) Performance Status
Baseline ECOG performance status 1 (N=30)
|
6.71 Months
Interval 4.67 to 8.78
|
Adverse Events
Pemetrexed, Gemcitabine, and Bevacizumab
Serious events: 26 serious events
Other events: 46 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pemetrexed, Gemcitabine, and Bevacizumab
n=48 participants at risk
All subjects received treatment with pemetrexed 500 mg/m\^2, gemcitabine 1500 mg/m\^2, and bevacizumab 10 mg/kg every 2 weeks.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Blood and lymphatic system disorders
Neutropenia
|
6.2%
3/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Cardiac disorders
Atrial fibrillation
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Cardiac disorders
Cardiac failure congestive
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Cardiac disorders
Sinus arrhythmia
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Eye disorders
Visual impairment
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Gastrointestinal disorders
Constipation
|
4.2%
2/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Gastrointestinal disorders
Gastrointestinal hemorrhage
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Gastrointestinal disorders
Nausea
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Gastrointestinal disorders
Vomiting
|
4.2%
2/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
General disorders
Adverse drug reaction
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
General disorders
Asthenia
|
4.2%
2/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
General disorders
Chest pain
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
General disorders
Fatigue
|
4.2%
2/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
General disorders
Edema peripheral
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
General disorders
Pain
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
General disorders
Pyrexia
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Infections and infestations
Cellulitis
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Infections and infestations
Gastroenteritis
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Infections and infestations
Pneumonia
|
8.3%
4/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Metabolism and nutrition disorders
Dehydration
|
6.2%
3/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.2%
2/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
4.2%
2/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Nervous system disorders
Cerebrovascular accident
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Nervous system disorders
Convulsion
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Nervous system disorders
Dizziness
|
4.2%
2/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Psychiatric disorders
Confusional state
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Psychiatric disorders
Hallucination
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Psychiatric disorders
Mental status changes
|
4.2%
2/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Renal and urinary disorders
Renal failure
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Renal and urinary disorders
Urinary incontinence
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.2%
3/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Vascular disorders
Deep vein thrombosis
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Vascular disorders
Thrombophlebitis superficial
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
Other adverse events
| Measure |
Pemetrexed, Gemcitabine, and Bevacizumab
n=48 participants at risk
All subjects received treatment with pemetrexed 500 mg/m\^2, gemcitabine 1500 mg/m\^2, and bevacizumab 10 mg/kg every 2 weeks.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
16/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Blood and lymphatic system disorders
Leukopenia
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Blood and lymphatic system disorders
Neutropenia
|
31.2%
15/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
18.8%
9/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Endocrine disorders
Hypothyroidism
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Eye disorders
Eye irritation
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Eye disorders
Eye swelling
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Eye disorders
Lacrimation increased
|
10.4%
5/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Eye disorders
Periorbital edema
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Eye disorders
Vision blurred
|
4.2%
2/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Eye disorders
Visual impairment
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Eye disorders
Vitreous hemorrhage
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Gastrointestinal disorders
Abdominal pain
|
8.3%
4/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Gastrointestinal disorders
Cheilitis
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Gastrointestinal disorders
Constipation
|
18.8%
9/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Gastrointestinal disorders
Diarrhea
|
31.2%
15/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Gastrointestinal disorders
Dry mouth
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Gastrointestinal disorders
Dyspepsia
|
10.4%
5/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Gastrointestinal disorders
Dysphagia
|
6.2%
3/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
4.2%
2/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Gastrointestinal disorders
Hemorrhoids
|
4.2%
2/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Gastrointestinal disorders
Nausea
|
37.5%
18/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Gastrointestinal disorders
Esophagitis
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Gastrointestinal disorders
Oral discomfort
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Gastrointestinal disorders
Oral pain
|
6.2%
3/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Gastrointestinal disorders
Stomatitis
|
27.1%
13/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
6/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
General disorders
Asthenia
|
14.6%
7/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
General disorders
Catheter site erosion
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
General disorders
Catheter site pain
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
General disorders
Chest pain
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
General disorders
Chills
|
6.2%
3/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
General disorders
Device occlusion
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
General disorders
Face edema
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
General disorders
Fatigue
|
62.5%
30/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
General disorders
Gait disturbance
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
General disorders
Irritability
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
General disorders
Malaise
|
6.2%
3/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
General disorders
Mucosal inflammation
|
10.4%
5/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
General disorders
Edema
|
6.2%
3/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
General disorders
Edema peripheral
|
18.8%
9/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
General disorders
Pain
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
General disorders
Pyrexia
|
16.7%
8/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
General disorders
Swelling
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
General disorders
Thirst
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Immune system disorders
Seasonal allergy
|
4.2%
2/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Infections and infestations
Anal abscess
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Infections and infestations
Cellulitis
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Infections and infestations
Clostridial infection
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Infections and infestations
Cystitis
|
6.2%
3/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Infections and infestations
Fungal infection
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Infections and infestations
Influenza
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Infections and infestations
Localized infection
|
4.2%
2/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Infections and infestations
Lower respiratory infection
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Infections and infestations
Nasopharyngitis
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Infections and infestations
Oral candidiasis
|
4.2%
2/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Infections and infestations
Oral herpes
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Infections and infestations
Perirectal abscess
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Infections and infestations
Pneumonia
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Infections and infestations
Rhinitis
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Infections and infestations
Sinusitis
|
10.4%
5/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Infections and infestations
Skin infection
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Infections and infestations
Staphylococcal infection
|
4.2%
2/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Infections and infestations
Urinary tract infection
|
12.5%
6/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Injury, poisoning and procedural complications
Contusion
|
6.2%
3/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Injury, poisoning and procedural complications
Excoriation
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Injury, poisoning and procedural complications
Fall
|
4.2%
2/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Injury, poisoning and procedural complications
Laceration
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Injury, poisoning and procedural complications
Periorbital hematoma
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Investigations
Alanine aminotransferase
|
6.2%
3/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Investigations
Alanine aminotransferase increased
|
6.2%
3/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Investigations
Aspartate aminotransferase
|
4.2%
2/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Investigations
Aspartate aminotransferase increased
|
4.2%
2/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Investigations
Blood alkaline phosphatase increased
|
4.2%
2/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Investigations
Blood creatinine
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Investigations
Blood creatinine increased
|
4.2%
2/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Investigations
Glomerular filtration rate
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Investigations
Neutrophil count
|
4.2%
2/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Investigations
Neutrophil count increased
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Investigations
Occult blood positive
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Investigations
Weight decreased
|
8.3%
4/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
25.0%
12/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Metabolism and nutrition disorders
Dehydration
|
14.6%
7/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Metabolism and nutrition disorders
Fluid retention
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
8.3%
4/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
6.2%
3/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
6.2%
3/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
6.2%
3/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
6.2%
3/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Metabolism and nutrition disorders
Hypophagia
|
4.2%
2/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.2%
2/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.6%
7/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
4.2%
2/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.2%
3/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Nervous system disorders
Ataxia
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Nervous system disorders
Cerebral atrophy
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Nervous system disorders
Dizziness
|
16.7%
8/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Nervous system disorders
Dysgeusia
|
18.8%
9/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Nervous system disorders
Headache
|
8.3%
4/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Nervous system disorders
Hypoesthesia
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Nervous system disorders
Lethargy
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Nervous system disorders
Memory impairment
|
4.2%
2/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Nervous system disorders
Tremor
|
4.2%
2/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Psychiatric disorders
Anxiety
|
4.2%
2/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Psychiatric disorders
Confusional state
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Psychiatric disorders
Depressed mood
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Psychiatric disorders
Depression
|
4.2%
2/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Psychiatric disorders
Disorientation
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Psychiatric disorders
Insomnia
|
18.8%
9/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Psychiatric disorders
Mood altered
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Psychiatric disorders
Psychotic disorder
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Renal and urinary disorders
Bladder pain
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Renal and urinary disorders
Dysuria
|
4.2%
2/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Renal and urinary disorders
Incontinence
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Renal and urinary disorders
Nocturia
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Renal and urinary disorders
Pollakiuria
|
4.2%
2/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Renal and urinary disorders
Proteinuria
|
12.5%
6/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Renal and urinary disorders
Renal pain
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Renal and urinary disorders
Urinary bladder hemorrhage
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Renal and urinary disorders
Urinary retention
|
4.2%
2/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Renal and urinary disorders
Urogenital hemorrhage
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.8%
10/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
6.2%
3/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
27.1%
13/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea exertional
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
14.6%
7/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
4.2%
2/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
6.2%
3/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.2%
3/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hemorrhage
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
4.2%
2/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Rhonchi
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
8.3%
4/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
4.2%
2/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
4.2%
2/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Skin and subcutaneous tissue disorders
Exfoliative rash
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
6.2%
3/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.2%
2/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.6%
7/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Surgical and medical procedures
Catheter placement
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Vascular disorders
Embolism venous
|
4.2%
2/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Vascular disorders
Flushing
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Vascular disorders
Hematoma
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Vascular disorders
Hypertension
|
8.3%
4/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Vascular disorders
Hypotension
|
6.2%
3/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
|
Vascular disorders
Orthostatic hypotension
|
2.1%
1/48 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 54 weeks.
|
Additional Information
Vice President of Scientific Affairs
Accelerated Community Oncology Research Network, Inc.
Phone: 901-435-5570
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee A copy of the proposed publication or presentation must be submitted to the funders for review and comment two months prior to the presentation or submission for publication. An additional 60 day delay of presentation or publication may be requested by the funder.
- Publication restrictions are in place
Restriction type: OTHER