Trial Outcomes & Findings for Alemtuzumab/Fludarabine for Relapsed/Refractory B-cell Chronic Lymphocytic Leukemia (B-CLL) (NCT NCT00206726)
NCT ID: NCT00206726
Last Updated: 2016-08-29
Results Overview
Participants evaluated for therapeutic clinical response according to National Cancer Institute (NCI) response criteria, 28 days after 4 or 6 treatment cycles. Response confirmation involved bone marrow biopsy and aspirate performed 2 months after final treatment. CR requires for at least 2 months: no lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; normal complete blood count (CBC); confirmed by bone marrow aspirate and biopsy 2 months later with lymphocytes \<30% of nucleated cells and procedure repeated in 4 weeks if hypocellular.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
28 days after last cycle with confirmation 2 months later
Results posted on
2016-08-29
Participant Flow
The study was conducted at 27 centers in the United States from 12 May 2005 (date of first participant's first visit) to 10 April 2008 (date of last participant's last visit)
66 screened, 6 screen failures, 60 enrolled and registered (Intent-to-Treat \[ITT\] population), 3 withdrew consent prior to receiving therapy = 57 treated (Safety population); 41 received at least 4 therapy cycles with no major protocol deviation or progressed/relapsed or died before completing 4 cycles (Per Protocol \[PP\] population)
Participant milestones
| Measure |
Alemtuzumab Plus Fludarabine
Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days
|
|---|---|
|
Overall Study
STARTED
|
60
|
|
Overall Study
Treatment Started
|
57
|
|
Overall Study
4 Cycles Completed
|
41
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
51
|
Reasons for withdrawal
| Measure |
Alemtuzumab Plus Fludarabine
Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days
|
|---|---|
|
Overall Study
Delayed recovery of blood counts
|
1
|
|
Overall Study
Progressive disease or relapsed disease
|
18
|
|
Overall Study
Placed on new protocol
|
1
|
|
Overall Study
Bone marrow transplant
|
1
|
|
Overall Study
Adverse Event
|
17
|
|
Overall Study
Death
|
4
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Withdrawal by Subject
|
8
|
Baseline Characteristics
Alemtuzumab/Fludarabine for Relapsed/Refractory B-cell Chronic Lymphocytic Leukemia (B-CLL)
Baseline characteristics by cohort
| Measure |
Alemtuzumab Plus Fludarabine
n=60 Participants
Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days
|
|---|---|
|
Age, Continuous
|
62 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=93 Participants
|
|
Beta 2-micro-globulin
< 2 milligrams per liter (mg/L) or missing
|
12 Participants
n=93 Participants
|
|
Beta 2-micro-globulin
>= 2mg/L
|
48 Participants
n=93 Participants
|
|
Lymph node size
< 5 centimeters (cm)
|
43 participants
n=93 Participants
|
|
Lymph node size
>= 5 cm
|
12 participants
n=93 Participants
|
|
Lymph node size
missing
|
5 participants
n=93 Participants
|
|
Number of prior cancer therapies
1
|
10 Participants
n=93 Participants
|
|
Number of prior cancer therapies
2
|
14 Participants
n=93 Participants
|
|
Number of prior cancer therapies
3
|
13 Participants
n=93 Participants
|
|
Number of prior cancer therapies
4
|
5 Participants
n=93 Participants
|
|
Number of prior cancer therapies
5-10
|
16 Participants
n=93 Participants
|
|
Number of prior cancer therapies
>10
|
2 Participants
n=93 Participants
|
|
Rai Stage
0
|
5 participants
n=93 Participants
|
|
Rai Stage
1 to 2
|
22 participants
n=93 Participants
|
|
Rai Stage
3 to 4
|
33 participants
n=93 Participants
|
|
Rai Stage
Missing
|
0 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 28 days after last cycle with confirmation 2 months laterPopulation: ITT population (all enrolled and registered subjects).
Participants evaluated for therapeutic clinical response according to National Cancer Institute (NCI) response criteria, 28 days after 4 or 6 treatment cycles. Response confirmation involved bone marrow biopsy and aspirate performed 2 months after final treatment. CR requires for at least 2 months: no lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; normal complete blood count (CBC); confirmed by bone marrow aspirate and biopsy 2 months later with lymphocytes \<30% of nucleated cells and procedure repeated in 4 weeks if hypocellular.
Outcome measures
| Measure |
Alemtuzumab Plus Fludarabine
n=60 Participants
Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days
|
|---|---|
|
Complete Response (CR)
|
8.3 Percentage of participants with CR
|
SECONDARY outcome
Timeframe: 28 days after last cycle with confirmation 2 months laterPopulation: ITT Population (all subjects enrolled and registered).
Participant had either complete response (CR) or partial response (PR) at 28 days after last treatment cycle (date of OR) and at Months 2 follow-up. PR requires for at least 2 months: 50% decrease from Baseline in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence or absence of constitutional symptoms; plus ≥1 of the following: ≥1500/μL polymorphonuclear leukocytes, \>100000/μL platelets, \>11.0 g/dL hemoglobin, or 50% improvement from Baseline for these parameters without transfusions, nodular CR or persistent anemia/thrombocytopenia unrelated to disease.
Outcome measures
| Measure |
Alemtuzumab Plus Fludarabine
n=60 Participants
Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days
|
|---|---|
|
Overall Response (OR)
|
28.3 Percentage of participants with CR or PR
|
SECONDARY outcome
Timeframe: 1 year after start of treatmentPopulation: Safety Population (all subjects treated)
Percentage of participants alive 1 year after the first dose date, described as Kaplan-Meier estimate at 1 year
Outcome measures
| Measure |
Alemtuzumab Plus Fludarabine
n=57 Participants
Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days
|
|---|---|
|
Overall Survival (OS)
|
86.4 Percentage of participants alive
|
SECONDARY outcome
Timeframe: 1 year after start of treatmentPopulation: ITT population (all subjects enrolled and registered). As three subjects never received study medication, they were to be censored at day 1 for all time-to-event analyses. Thus, the Kaplan-Meier estimates beyond day one are the same for both, the ITT and the safety population.
Percentage of participants who survived progression-free at 1 year, described as Kaplan-Meier estimate at 1 year
Outcome measures
| Measure |
Alemtuzumab Plus Fludarabine
n=60 Participants
Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days
|
|---|---|
|
Progression-free Survival (PFS)
|
48.8 percentage alive without progression
|
SECONDARY outcome
Timeframe: from first date of confirmed response until relapse, or death, or study data cutoff date, whichever is earlierPopulation: Subjects who achieved Overall Response (OR) defined as number of subjects who achieved CR + number of subjects who achieved PR
Participant had either complete response (CR) or partial response (PR) at different observation times (after 90 days; after 180 days; after 270 days). PR requires for at least 2 months: 50% decrease from Baseline in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence or absence of constitutional symptoms; plus ≥1 of the following: ≥1500/μL polymorphonuclear leukocytes, \>100000/μL platelets, \>11.0 g/dL hemoglobin, or 50% improvement from Baseline for these parameters without transfusions, nodular CR or persistent anemia/thrombocytopenia unrelated to disease.
Outcome measures
| Measure |
Alemtuzumab Plus Fludarabine
n=17 Participants
Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days
|
|---|---|
|
Percentage of Participants With Overall Response at Different Observation Times
After 270 days
|
29.4 percentage of participants in response
|
|
Percentage of Participants With Overall Response at Different Observation Times
After 90 days
|
76.5 percentage of participants in response
|
|
Percentage of Participants With Overall Response at Different Observation Times
After 180 days
|
64.7 percentage of participants in response
|
SECONDARY outcome
Timeframe: When CR is confirmedPopulation: All participants for whom CR was confirmed
Presence of MRD was assessed by laboratory testing of molecular responses in blood and bone marrow samples.
Outcome measures
| Measure |
Alemtuzumab Plus Fludarabine
n=5 Participants
Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days
|
|---|---|
|
Number of Participants With Minimal Residual Disease (MRD)
Positive
|
3 participants
|
|
Number of Participants With Minimal Residual Disease (MRD)
Negative
|
2 participants
|
|
Number of Participants With Minimal Residual Disease (MRD)
Not Assessed
|
0 participants
|
Adverse Events
Alemtuzumab Plus Fludarabine
Serious events: 41 serious events
Other events: 55 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Alemtuzumab Plus Fludarabine
n=57 participants at risk
Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
1.8%
1/57
|
|
Infections and infestations
Acute sinusitis
|
1.8%
1/57
|
|
Infections and infestations
Adenovirus infection
|
1.8%
1/57
|
|
Blood and lymphatic system disorders
Anaemia
|
15.8%
9/57
|
|
Cardiac disorders
Angina pectoris
|
1.8%
1/57
|
|
Metabolism and nutrition disorders
Anorexia
|
1.8%
1/57
|
|
General disorders
Asthenia
|
3.5%
2/57
|
|
Infections and infestations
Bacteraemia
|
3.5%
2/57
|
|
Infections and infestations
Blastomycosis
|
1.8%
1/57
|
|
Investigations
Blood calcium decreased
|
1.8%
1/57
|
|
Investigations
Blood creatinine increased
|
1.8%
1/57
|
|
Infections and infestations
Bronchopneumonia
|
1.8%
1/57
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
1.8%
1/57
|
|
General disorders
Chills
|
1.8%
1/57
|
|
Hepatobiliary disorders
Cholangitis
|
1.8%
1/57
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.8%
1/57
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia transformation
|
3.5%
2/57
|
|
Blood and lymphatic system disorders
Coagulopathy
|
1.8%
1/57
|
|
Psychiatric disorders
Confusional state
|
1.8%
1/57
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.8%
1/57
|
|
Infections and infestations
Cytomegalovirus infection
|
1.8%
1/57
|
|
Metabolism and nutrition disorders
Dehydration
|
5.3%
3/57
|
|
Gastrointestinal disorders
Diarrhoea
|
5.3%
3/57
|
|
General disorders
Disease progression
|
5.3%
3/57
|
|
Psychiatric disorders
Disorientation
|
1.8%
1/57
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.5%
2/57
|
|
Infections and infestations
Enterococcal bacteriaemia
|
1.8%
1/57
|
|
Investigations
Epstein-Barr virus test positive
|
1.8%
1/57
|
|
General disorders
Fatigue
|
3.5%
2/57
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
22.8%
13/57
|
|
Infections and infestations
Gastroenteritis
|
1.8%
1/57
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.8%
1/57
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.8%
1/57
|
|
Vascular disorders
Haemorrhage
|
1.8%
1/57
|
|
Nervous system disorders
Headache
|
1.8%
1/57
|
|
Hepatobiliary disorders
Hepatic failure
|
1.8%
1/57
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.8%
1/57
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
3.5%
2/57
|
|
Vascular disorders
Hypotension
|
3.5%
2/57
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.3%
3/57
|
|
Nervous system disorders
Hypoxic encephalopathy
|
1.8%
1/57
|
|
Infections and infestations
Infection
|
1.8%
1/57
|
|
General disorders
Influenza like illness
|
1.8%
1/57
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
1.8%
1/57
|
|
Blood and lymphatic system disorders
Leukopenia
|
3.5%
2/57
|
|
Infections and infestations
Liver abscess
|
1.8%
1/57
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
1.8%
1/57
|
|
Infections and infestations
Lower respiratory tract infection bacterial
|
1.8%
1/57
|
|
Infections and infestations
Lung infection pseudomonal
|
1.8%
1/57
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
1.8%
1/57
|
|
Blood and lymphatic system disorders
Lymphopenia
|
1.8%
1/57
|
|
Psychiatric disorders
Mental status changes
|
3.5%
2/57
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
1.8%
1/57
|
|
General disorders
Multi-organ failure
|
1.8%
1/57
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
1.8%
1/57
|
|
Nervous system disorders
Myelitis
|
1.8%
1/57
|
|
Gastrointestinal disorders
Nausea
|
5.3%
3/57
|
|
Nervous system disorders
Neuropathy peripheral
|
1.8%
1/57
|
|
Nervous system disorders
Neurotoxicity
|
1.8%
1/57
|
|
Blood and lymphatic system disorders
Neutropenia
|
3.5%
2/57
|
|
Renal and urinary disorders
Obstructive uropathy
|
1.8%
1/57
|
|
Blood and lymphatic system disorders
Pancytopenia
|
3.5%
2/57
|
|
Infections and infestations
Pneumonia
|
7.0%
4/57
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
1.8%
1/57
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prolymphocytic Leukaemia
|
1.8%
1/57
|
|
General disorders
Pyrexia
|
19.3%
11/57
|
|
Renal and urinary disorders
Renal failure
|
5.3%
3/57
|
|
Renal and urinary disorders
Renal failure acute
|
5.3%
3/57
|
|
Renal and urinary disorders
Renal tubular necrosis
|
1.8%
1/57
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
3.5%
2/57
|
|
Infections and infestations
Sepsis
|
1.8%
1/57
|
|
Infections and infestations
Sepsis syndrome
|
1.8%
1/57
|
|
Infections and infestations
Septic shock
|
5.3%
3/57
|
|
Infections and infestations
Sinusitis
|
1.8%
1/57
|
|
Infections and infestations
Sinusitis fungal
|
1.8%
1/57
|
|
Infections and infestations
Splenic abscess
|
1.8%
1/57
|
|
Nervous system disorders
Syncope
|
1.8%
1/57
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.5%
2/57
|
|
Renal and urinary disorders
Urinary incontinence
|
1.8%
1/57
|
|
Infections and infestations
Urinary tract infection
|
3.5%
2/57
|
|
Gastrointestinal disorders
Vomiting
|
5.3%
3/57
|
Other adverse events
| Measure |
Alemtuzumab Plus Fludarabine
n=57 participants at risk
Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days
|
|---|---|
|
Gastrointestinal disorders
Abdominal Distension
|
3.5%
2/57
|
|
Gastrointestinal disorders
Abdominal discomfort
|
3.5%
2/57
|
|
Gastrointestinal disorders
Abdominal pain
|
12.3%
7/57
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.8%
1/57
|
|
Gastrointestinal disorders
Abdominal tenderness
|
1.8%
1/57
|
|
Metabolism and nutrition disorders
Acidosis
|
1.8%
1/57
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
1.8%
1/57
|
|
Investigations
Alanine aminotransferase increased
|
5.3%
3/57
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.8%
1/57
|
|
Blood and lymphatic system disorders
Anaemia
|
52.6%
30/57
|
|
Metabolism and nutrition disorders
Anorexia
|
22.8%
13/57
|
|
Psychiatric disorders
Anxiety
|
5.3%
3/57
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.8%
5/57
|
|
Investigations
Aspartate Aminotransferase increased
|
5.3%
3/57
|
|
General disorders
Asthenia
|
10.5%
6/57
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.8%
1/57
|
|
General disorders
Axillary pain
|
1.8%
1/57
|
|
Renal and urinary disorders
Azotaemia
|
1.8%
1/57
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.3%
7/57
|
|
Investigations
Bacterial test positive
|
3.5%
2/57
|
|
Investigations
Blood alkaline phosphatase increased
|
5.3%
3/57
|
|
Investigations
Blood bicarbonate decreased
|
1.8%
1/57
|
|
Investigations
Blood bilirubin unconjugated increased
|
1.8%
1/57
|
|
Investigations
Blood creatinine increased
|
1.8%
1/57
|
|
Investigations
Blood lactate dehydrogenase increased
|
1.8%
1/57
|
|
Investigations
Blood potassium decreased
|
1.8%
1/57
|
|
Investigations
Blood pressure increased
|
1.8%
1/57
|
|
Investigations
Body temperature increased
|
1.8%
1/57
|
|
Infections and infestations
Body tinea
|
1.8%
1/57
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
7.0%
4/57
|
|
Reproductive system and breast disorders
Breast pain
|
1.8%
1/57
|
|
Infections and infestations
Bronchitis
|
5.3%
3/57
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
1.8%
1/57
|
|
Metabolism and nutrition disorders
Cachexia
|
1.8%
1/57
|
|
Metabolism and nutrition disorders
Calcium deficiency
|
1.8%
1/57
|
|
Infections and infestations
Candidiasis
|
1.8%
1/57
|
|
Investigations
Cardiac murmur
|
1.8%
1/57
|
|
Gastrointestinal disorders
Chapped lips
|
1.8%
1/57
|
|
General disorders
Chest discomfort
|
3.5%
2/57
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
1.8%
1/57
|
|
General disorders
Chills
|
31.6%
18/57
|
|
Hepatobiliary disorders
Cholecystitis
|
1.8%
1/57
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.8%
1/57
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
1.8%
1/57
|
|
Infections and infestations
Chronic sinusitis
|
1.8%
1/57
|
|
Gastrointestinal disorders
Colitis
|
1.8%
1/57
|
|
Psychiatric disorders
Confusional state
|
5.3%
3/57
|
|
Gastrointestinal disorders
Constipation
|
26.3%
15/57
|
|
Injury, poisoning and procedural complications
Contusion
|
5.3%
3/57
|
|
Nervous system disorders
Convulsion
|
1.8%
1/57
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
31.6%
18/57
|
|
Respiratory, thoracic and mediastinal disorders
Crackles lung
|
3.5%
2/57
|
|
Infections and infestations
Cytomegalovirus infection
|
3.5%
2/57
|
|
Investigations
Cytomegalovirus test positive
|
38.6%
22/57
|
|
Metabolism and nutrition disorders
Decreased appetite
|
10.5%
6/57
|
|
Metabolism and nutrition disorders
Dehydration
|
5.3%
3/57
|
|
Psychiatric disorders
Depression
|
3.5%
2/57
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
1.8%
1/57
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
19/57
|
|
Eye disorders
Diplopia
|
1.8%
1/57
|
|
General disorders
Disease progression
|
22.8%
13/57
|
|
Psychiatric disorders
Disorientation
|
1.8%
1/57
|
|
Nervous system disorders
Dizziness
|
12.3%
7/57
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
1.8%
1/57
|
|
Gastrointestinal disorders
Dry mouth
|
1.8%
1/57
|
|
Nervous system disorders
Dysgeusia
|
3.5%
2/57
|
|
Gastrointestinal disorders
Dyspepsia
|
7.0%
4/57
|
|
Gastrointestinal disorders
Dysphagia
|
7.0%
4/57
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
3.5%
2/57
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
31.6%
18/57
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
7.0%
4/57
|
|
Renal and urinary disorders
Dysuria
|
1.8%
1/57
|
|
Infections and infestations
Ear infection
|
1.8%
1/57
|
|
Ear and labyrinth disorders
Ear pain
|
5.3%
3/57
|
|
General disorders
Early satiety
|
1.8%
1/57
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
5.3%
3/57
|
|
Blood and lymphatic system disorders
Eosinophilia
|
1.8%
1/57
|
|
Reproductive system and breast disorders
Epididymitis
|
1.8%
1/57
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.3%
3/57
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
1.8%
1/57
|
|
Skin and subcutaneous tissue disorders
Erythema
|
3.5%
2/57
|
|
Injury, poisoning and procedural complications
Excoriation
|
1.8%
1/57
|
|
Eye disorders
Eye pain
|
1.8%
1/57
|
|
Eye disorders
Eyelid oedema
|
1.8%
1/57
|
|
General disorders
Face oedema
|
1.8%
1/57
|
|
Nervous system disorders
Facial palsy
|
1.8%
1/57
|
|
Gastrointestinal disorders
Faeces hard
|
1.8%
1/57
|
|
Injury, poisoning and procedural complications
Fall
|
1.8%
1/57
|
|
General disorders
Fatigue
|
52.6%
30/57
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.5%
2/57
|
|
Gastrointestinal disorders
Flatulence
|
1.8%
1/57
|
|
Gastrointestinal disorders
Gastric ulcer
|
1.8%
1/57
|
|
Infections and infestations
Gastroenteritis
|
1.8%
1/57
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
1.8%
1/57
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.3%
3/57
|
|
Reproductive system and breast disorders
Genital pruritus female
|
1.8%
1/57
|
|
Infections and infestations
Gingival infection
|
3.5%
2/57
|
|
Gastrointestinal disorders
Glossodynia
|
1.8%
1/57
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
1.8%
1/57
|
|
Endocrine disorders
Goitre
|
1.8%
1/57
|
|
Investigations
Granulocyte count decreased
|
1.8%
1/57
|
|
Blood and lymphatic system disorders
Granulocytopenia
|
10.5%
6/57
|
|
Renal and urinary disorders
Haematuria
|
1.8%
1/57
|
|
Investigations
Haemoglobin decreased
|
7.0%
4/57
|
|
Blood and lymphatic system disorders
Haemolysis
|
1.8%
1/57
|
|
Blood and lymphatic system disorders
Haemolytic Anaemia
|
8.8%
5/57
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.8%
1/57
|
|
Vascular disorders
Haemorrhage
|
1.8%
1/57
|
|
Nervous system disorders
Headache
|
10.5%
6/57
|
|
Investigations
Heart rate increased
|
1.8%
1/57
|
|
Investigations
Heart sounds abnormal
|
1.8%
1/57
|
|
Hepatobiliary disorders
Hepatic mass
|
1.8%
1/57
|
|
Hepatobiliary disorders
Hepatomegaly
|
1.8%
1/57
|
|
General disorders
Hernia pain
|
1.8%
1/57
|
|
Infections and infestations
Herpes zoster
|
7.0%
4/57
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
3.5%
2/57
|
|
Vascular disorders
Hot flush
|
1.8%
1/57
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
1.8%
1/57
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
1.8%
1/57
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
7.0%
4/57
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
7.0%
4/57
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
5.3%
3/57
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
1.8%
1/57
|
|
Vascular disorders
Hypertension
|
3.5%
2/57
|
|
Nervous system disorders
Hypoaesthesia
|
5.3%
3/57
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
1.8%
1/57
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
3.5%
2/57
|
|
Immune system disorders
Hypogammaglobulinaemia
|
1.8%
1/57
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
15.8%
9/57
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
7.0%
4/57
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
10.5%
6/57
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
1.8%
1/57
|
|
Vascular disorders
Hypotension
|
14.0%
8/57
|
|
General disorders
Hypothermia
|
1.8%
1/57
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
1.8%
1/57
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.8%
1/57
|
|
Immune system disorders
Immunosuppression
|
1.8%
1/57
|
|
Infections and infestations
Infection
|
1.8%
1/57
|
|
General disorders
Infusion related reaction
|
1.8%
1/57
|
|
General disorders
Injection site erythema
|
8.8%
5/57
|
|
General disorders
Injection site irritation
|
1.8%
1/57
|
|
General disorders
Injection site pain
|
5.3%
3/57
|
|
General disorders
Injection site rash
|
1.8%
1/57
|
|
General disorders
Injection site reaction
|
5.3%
3/57
|
|
General disorders
Injection site warmth
|
1.8%
1/57
|
|
Psychiatric disorders
Insomnia
|
12.3%
7/57
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
1.8%
1/57
|
|
Hepatobiliary disorders
Jaundice
|
1.8%
1/57
|
|
Blood and lymphatic system disorders
Leukocytosis
|
1.8%
1/57
|
|
Blood and lymphatic system disorders
Leukopenia
|
31.6%
18/57
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
1.8%
1/57
|
|
General disorders
Local swelling
|
1.8%
1/57
|
|
Infections and infestations
Lung infection
|
1.8%
1/57
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
3.5%
2/57
|
|
Blood and lymphatic system disorders
Lymphocytosis
|
1.8%
1/57
|
|
Blood and lymphatic system disorders
Lymphopenia
|
3.5%
2/57
|
|
Metabolism and nutrition disorders
Magnesium deficiency
|
1.8%
1/57
|
|
Injury, poisoning and procedural complications
Medical device pain
|
1.8%
1/57
|
|
Nervous system disorders
Memory impairment
|
1.8%
1/57
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
1.8%
1/57
|
|
Renal and urinary disorders
Micturition disorder
|
1.8%
1/57
|
|
Renal and urinary disorders
Micturition urgency
|
1.8%
1/57
|
|
General disorders
Mucosal erosion
|
1.8%
1/57
|
|
General disorders
Mucosal inflammation
|
5.3%
3/57
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.8%
1/57
|
|
Musculoskeletal and connective tissue disorders
Muscucoskeletal stiffness
|
1.8%
1/57
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
1.8%
1/57
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.8%
1/57
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.8%
5/57
|
|
Infections and infestations
Mycobacterium avium complex infection
|
1.8%
1/57
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.8%
1/57
|
|
Infections and infestations
Nasopharyngitis
|
8.8%
5/57
|
|
Gastrointestinal disorders
Nausea
|
56.1%
32/57
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.8%
1/57
|
|
Nervous system disorders
Neuropathy peripheral
|
1.8%
1/57
|
|
Blood and lymphatic system disorders
Neutropenia
|
59.6%
34/57
|
|
Investigations
Neutrophil count decreased
|
10.5%
6/57
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
10.5%
6/57
|
|
General disorders
Non-cardiac chest pain
|
1.8%
1/57
|
|
Gastrointestinal disorders
Odynophagia
|
1.8%
1/57
|
|
General disorders
Oedema
|
3.5%
2/57
|
|
General disorders
Oedema peripheral
|
12.3%
7/57
|
|
Gastrointestinal disorders
Oesophagitis
|
1.8%
1/57
|
|
Vascular disorders
Orthostatic hypotension
|
1.8%
1/57
|
|
General disorders
Pain
|
8.8%
5/57
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.3%
3/57
|
|
Vascular disorders
Pallor
|
1.8%
1/57
|
|
Cardiac disorders
Palpitations
|
1.8%
1/57
|
|
Blood and lymphatic system disorders
Pancytopenia
|
3.5%
2/57
|
|
Nervous system disorders
Paraesthesia
|
1.8%
1/57
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
1.8%
1/57
|
|
Nervous system disorders
Peroneal nerve palsy
|
1.8%
1/57
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
5.3%
3/57
|
|
Infections and infestations
Pharyngitis
|
1.8%
1/57
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
14.0%
8/57
|
|
Investigations
Platelet count decreased
|
7.0%
4/57
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.5%
2/57
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
1.8%
1/57
|
|
Infections and infestations
Pneumonia
|
7.0%
4/57
|
|
Infections and infestations
Pneumonia cytomegaloviral
|
1.8%
1/57
|
|
Renal and urinary disorders
Pollakiuria
|
1.8%
1/57
|
|
Nervous system disorders
Post herpetic neuralgia
|
1.8%
1/57
|
|
Injury, poisoning and procedural complications
Procedural pain
|
3.5%
2/57
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
3.5%
2/57
|
|
Renal and urinary disorders
Proteinuria
|
1.8%
1/57
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.5%
6/57
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
3.5%
2/57
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
1.8%
1/57
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
1.8%
1/57
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
1.8%
1/57
|
|
General disorders
Pyrexia
|
47.4%
27/57
|
|
Skin and subcutaneous tissue disorders
Rash
|
19.3%
11/57
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
1.8%
1/57
|
|
Skin and subcutaneous tissue disorders
Rash generalized
|
1.8%
1/57
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
1.8%
1/57
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
1.8%
1/57
|
|
Investigations
Red blood cell count decreased
|
1.8%
1/57
|
|
Renal and urinary disorders
Renal failure
|
1.8%
1/57
|
|
Renal and urinary disorders
Renal failure acute
|
3.5%
2/57
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
1.8%
1/57
|
|
Infections and infestations
Respiratory tract infection
|
1.8%
1/57
|
|
Infections and infestations
Rhinitis
|
14.0%
8/57
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
1.8%
1/57
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
1.8%
1/57
|
|
Immune system disorders
Seasonal allergy
|
1.8%
1/57
|
|
Infections and infestations
Sepsis
|
3.5%
2/57
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
3.5%
2/57
|
|
Cardiac disorders
Sinus Tachycardia
|
1.8%
1/57
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
1.8%
1/57
|
|
Nervous system disorders
Sinus headache
|
1.8%
1/57
|
|
Infections and infestations
Sinusitis
|
7.0%
4/57
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
1.8%
1/57
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
1.8%
1/57
|
|
Nervous system disorders
Somnolence
|
1.8%
1/57
|
|
Infections and infestations
Staphylococcal infection
|
1.8%
1/57
|
|
Injury, poisoning and procedural complications
Sunburn
|
1.8%
1/57
|
|
General disorders
Suprapubic pain
|
1.8%
1/57
|
|
Nervous system disorders
Syncope
|
1.8%
1/57
|
|
Cardiac disorders
Tachycardia
|
10.5%
6/57
|
|
Reproductive system and breast disorders
Testicular pain
|
1.8%
1/57
|
|
Respiratory, thoracic and mediastinal disorders
Throat lesion
|
1.8%
1/57
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
45.6%
26/57
|
|
Ear and labyrinth disorders
Tinnitus
|
1.8%
1/57
|
|
Gastrointestinal disorders
Toothache
|
1.8%
1/57
|
|
Investigations
Transaminases increased
|
3.5%
2/57
|
|
Nervous system disorders
Tremor
|
3.5%
2/57
|
|
Investigations
Troponin increased
|
1.8%
1/57
|
|
Infections and infestations
Upper respiratory tract infection
|
3.5%
2/57
|
|
Renal and urinary disorders
Urinary incontinence
|
1.8%
1/57
|
|
Renal and urinary disorders
Urinary retention
|
3.5%
2/57
|
|
Infections and infestations
Urinary tract infection
|
1.8%
1/57
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
5.3%
3/57
|
|
Ear and labyrinth disorders
Vertigo
|
1.8%
1/57
|
|
Investigations
Viral DNA test positive
|
1.8%
1/57
|
|
Eye disorders
Vision blurred
|
3.5%
2/57
|
|
Gastrointestinal disorders
Vomiting
|
31.6%
18/57
|
|
Investigations
Weight decreased
|
8.8%
5/57
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
7.0%
4/57
|
|
Investigations
White blood cell count decreased
|
12.3%
7/57
|
|
Blood and lymphatic system disorders
White blood cell disorder
|
5.3%
3/57
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place