Trial Outcomes & Findings for Low-Dose Melphalan and Dexamethasone Compared With High-Dose Melphalan Followed By Autologous Stem Cell Transplant in Treating Patients With Primary Systemic Amyloidosis (NCT NCT00477971)
NCT ID: NCT00477971
Last Updated: 2016-05-17
Results Overview
Response that was confirmed on 2 consecutive evaluations during treatment. A hematologic response consisted of a Complete response, Very Good Partial Response or Partial Response. * Complete Response (CR): Complete disappearance of M-protein from serum and urine on immunofixation, normalization of Free Light Chain (FLC) ratio and \<5% plasma cells in bone marrow. * Very Good Partial Response (VGPR): \>=90% reduction in serum M-component; Urine M-Component \<=100 mg per 24 hours. * Partial Response (PR): \>=50% reduction in serum M-component and/or Urine M-Component \>=90% reduction or \<200 mg per 24 hours; or \>=50% decrease in difference between involved and uninvolved FLC levels.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
89 participants
Primary outcome timeframe
10 years
Results posted on
2016-05-17
Participant Flow
From October 2005 to August 2012, 89 participants were recruited.
This study was originally designed as a randomized Phase III clinical trial; however the unwillingness of participants to be randomized to treatment led to changes. The protocol was amended to allow participants to choose between the two regimens.
Participant milestones
| Measure |
Low-Dose Melphalan
Patients receive low-dose melphalan 20 mg/m\^2 IV over 15-30 minutes on day 1 or 0.12 mg/kg tablet orally once daily on days 1-7 and dexamethasone 40 mg orally on days 1-4 and 22-25. Treatment repeats every 6 weeks for 10 courses. (Study treatment beyond one year is not allowed.)
|
High-Dose Melphalan + Autologous HSC
Patients receive filgrastim (G-CSF) 10 mg/kg/day on days -7 to -3 and undergo autologous hematopoietic stem cell (HSC) collection. Patients receive high-dose melphalan 140 mg/m\^2 IV for low risk or 200 mg/m\^2 IV for high risk patients over 1 hour on days -2 and -1 and undergo autologous HSC transplantation on day 0.
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
55
|
|
Overall Study
COMPLETED
|
17
|
49
|
|
Overall Study
NOT COMPLETED
|
17
|
6
|
Reasons for withdrawal
| Measure |
Low-Dose Melphalan
Patients receive low-dose melphalan 20 mg/m\^2 IV over 15-30 minutes on day 1 or 0.12 mg/kg tablet orally once daily on days 1-7 and dexamethasone 40 mg orally on days 1-4 and 22-25. Treatment repeats every 6 weeks for 10 courses. (Study treatment beyond one year is not allowed.)
|
High-Dose Melphalan + Autologous HSC
Patients receive filgrastim (G-CSF) 10 mg/kg/day on days -7 to -3 and undergo autologous hematopoietic stem cell (HSC) collection. Patients receive high-dose melphalan 140 mg/m\^2 IV for low risk or 200 mg/m\^2 IV for high risk patients over 1 hour on days -2 and -1 and undergo autologous HSC transplantation on day 0.
|
|---|---|---|
|
Overall Study
Disease progression
|
6
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
|
Overall Study
Adverse Event
|
3
|
0
|
|
Overall Study
Death
|
2
|
4
|
|
Overall Study
Alternative treatment
|
3
|
1
|
Baseline Characteristics
Low-Dose Melphalan and Dexamethasone Compared With High-Dose Melphalan Followed By Autologous Stem Cell Transplant in Treating Patients With Primary Systemic Amyloidosis
Baseline characteristics by cohort
| Measure |
Low-Dose Melphalan
n=34 Participants
Patients receive low-dose melphalan 20 mg/m\^2 IV over 15-30 minutes on day 1 or 0.12 mg/kg tablet orally once daily on days 1-7 and dexamethasone 40 mg orally on days 1-4 and 22-25. Treatment repeats every 6 weeks for 10 courses. (Study treatment beyond one year is not allowed.)
|
High-Dose Melphalan + Autologous HSC
n=55 Participants
Patients receive filgrastim (G-CSF) 10 mg/kg/day on days -7 to -3 and undergo autologous hematopoietic stem cell (HSC) collection. Patients receive high-dose melphalan 140 mg/m\^2 IV for low risk or 200 mg/m\^2 IV for high risk patients over 1 hour on days -2 and -1 and undergo autologous HSC transplantation on day 0.
|
Total
n=89 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62 years
n=5 Participants
|
57 years
n=7 Participants
|
59 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
34 participants
n=5 Participants
|
55 participants
n=7 Participants
|
89 participants
n=5 Participants
|
|
ECOG Performance Score
0-1
|
25 participants
n=5 Participants
|
50 participants
n=7 Participants
|
75 participants
n=5 Participants
|
|
ECOG Performance Score
2
|
9 participants
n=5 Participants
|
5 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Risk Group
Low
|
20 participants
n=5 Participants
|
38 participants
n=7 Participants
|
58 participants
n=5 Participants
|
|
Risk Group
High
|
14 participants
n=5 Participants
|
17 participants
n=7 Participants
|
31 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 10 yearsResponse that was confirmed on 2 consecutive evaluations during treatment. A hematologic response consisted of a Complete response, Very Good Partial Response or Partial Response. * Complete Response (CR): Complete disappearance of M-protein from serum and urine on immunofixation, normalization of Free Light Chain (FLC) ratio and \<5% plasma cells in bone marrow. * Very Good Partial Response (VGPR): \>=90% reduction in serum M-component; Urine M-Component \<=100 mg per 24 hours. * Partial Response (PR): \>=50% reduction in serum M-component and/or Urine M-Component \>=90% reduction or \<200 mg per 24 hours; or \>=50% decrease in difference between involved and uninvolved FLC levels.
Outcome measures
| Measure |
Low-Dose Melphalan
n=34 Participants
Patients receive low-dose melphalan 20 mg/m\^2 IV over 15-30 minutes on day 1 or 0.12 mg/kg tablet orally once daily on days 1-7 and dexamethasone 40 mg orally on days 1-4 and 22-25. Treatment repeats every 6 weeks for 10 courses. (Study treatment beyond one year is not allowed.)
|
High-Dose Melphalan + Autologous HSC
n=55 Participants
Patients receive filgrastim (G-CSF) 10 mg/kg/day on days -7 to -3 and undergo autologous hematopoietic stem cell (HSC) collection. Patients receive high-dose melphalan 140 mg/m\^2 IV for low risk or 200 mg/m\^2 IV for high risk patients over 1 hour on days -2 and -1 and undergo autologous HSC transplantation on day 0.
|
|---|---|---|
|
Hematologic Response Rate
|
55.9 percentage of participants
Interval 37.9 to 72.8
|
69.1 percentage of participants
Interval 55.2 to 80.9
|
SECONDARY outcome
Timeframe: 3 yearsPercentage of patients who were alive at 3 years. The 3-year survival rate was estimated using the Kaplan Meier method.
Outcome measures
| Measure |
Low-Dose Melphalan
n=34 Participants
Patients receive low-dose melphalan 20 mg/m\^2 IV over 15-30 minutes on day 1 or 0.12 mg/kg tablet orally once daily on days 1-7 and dexamethasone 40 mg orally on days 1-4 and 22-25. Treatment repeats every 6 weeks for 10 courses. (Study treatment beyond one year is not allowed.)
|
High-Dose Melphalan + Autologous HSC
n=55 Participants
Patients receive filgrastim (G-CSF) 10 mg/kg/day on days -7 to -3 and undergo autologous hematopoietic stem cell (HSC) collection. Patients receive high-dose melphalan 140 mg/m\^2 IV for low risk or 200 mg/m\^2 IV for high risk patients over 1 hour on days -2 and -1 and undergo autologous HSC transplantation on day 0.
|
|---|---|---|
|
3 Year Overall Survival
|
58.8 percentage of participants
Interval 44.4 to 77.9
|
83.6 percentage of participants
Interval 74.7 to 94.0
|
SECONDARY outcome
Timeframe: 10 yearsOrgan response was evaluated on the basis of improvement of one or more affected organ; only one parameter was required to satisfy the criteria. Response needed to be maintained for a minimum of 3 months to be considered valid. Renal response required a 50% reduction in 24-hour urine protein excretion (at least 0.5 g/d) with stable creatinine. Cardiac response required one of \>= 2-mm reduction in the interventricular septal (IVS) thickness by echocardiogram, or improvement of ejection fraction by \>= 20%, or improvement by 2 NYHA classes without an increase in diuretic use. Hepatic response required either \>= 50% decrease in (or normalization of) an initially elevated alkaline phosphatase level or reduction in the size of the liver by at least 2 cm by radiographic determination. Gastrointestinal tract improvement was defined as normalization of a low serum carotene level, or reduction of diarrhea to \< 50% of previous movements/day, or decrease in fecal fat excretion by 50%.
Outcome measures
| Measure |
Low-Dose Melphalan
n=34 Participants
Patients receive low-dose melphalan 20 mg/m\^2 IV over 15-30 minutes on day 1 or 0.12 mg/kg tablet orally once daily on days 1-7 and dexamethasone 40 mg orally on days 1-4 and 22-25. Treatment repeats every 6 weeks for 10 courses. (Study treatment beyond one year is not allowed.)
|
High-Dose Melphalan + Autologous HSC
n=55 Participants
Patients receive filgrastim (G-CSF) 10 mg/kg/day on days -7 to -3 and undergo autologous hematopoietic stem cell (HSC) collection. Patients receive high-dose melphalan 140 mg/m\^2 IV for low risk or 200 mg/m\^2 IV for high risk patients over 1 hour on days -2 and -1 and undergo autologous HSC transplantation on day 0.
|
|---|---|---|
|
Organ Response to Treatment
|
26.5 percentage of participants
Interval 12.8 to 44.4
|
29.1 percentage of participants
Interval 17.6 to 42.9
|
POST_HOC outcome
Timeframe: 3 yearsPercentage of patients who were progression free at 3 years. The 3-year progression free rate was estimated using the Kaplan Meier method. Progression is assessed when one of the following occur: * reappearance of monoclonal protein by immunofixation, * Increase in serum monoclonal paraprotein to \>25% above the lowest response level, * Increase in urine M-protein to \> 25% above the lowest remission value for 24-hour excretion.
Outcome measures
| Measure |
Low-Dose Melphalan
n=34 Participants
Patients receive low-dose melphalan 20 mg/m\^2 IV over 15-30 minutes on day 1 or 0.12 mg/kg tablet orally once daily on days 1-7 and dexamethasone 40 mg orally on days 1-4 and 22-25. Treatment repeats every 6 weeks for 10 courses. (Study treatment beyond one year is not allowed.)
|
High-Dose Melphalan + Autologous HSC
n=55 Participants
Patients receive filgrastim (G-CSF) 10 mg/kg/day on days -7 to -3 and undergo autologous hematopoietic stem cell (HSC) collection. Patients receive high-dose melphalan 140 mg/m\^2 IV for low risk or 200 mg/m\^2 IV for high risk patients over 1 hour on days -2 and -1 and undergo autologous HSC transplantation on day 0.
|
|---|---|---|
|
3-Year Progression Free Survival
|
29.1 percentage of participants
Interval 17.2 to 49.4
|
51.7 percentage of participants
Interval 39.8 to 67.0
|
Adverse Events
Low-Dose Melphalan
Serious events: 6 serious events
Other events: 34 other events
Deaths: 0 deaths
High-Dose Melphalan + Autologous HSC
Serious events: 3 serious events
Other events: 55 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Low-Dose Melphalan
n=34 participants at risk
Patients receive low-dose melphalan 20 mg/m\^2 IV over 15-30 minutes on day 1 or 0.12 mg/kg tablet orally once daily on days 1-7 and dexamethasone 40 mg orally on days 1-4 and 22-25. Treatment repeats every 6 weeks for 10 courses. (Study treatment beyond one year is not allowed.)
|
High-Dose Melphalan + Autologous HSC
n=55 participants at risk
Patients receive filgrastim (G-CSF) 10 mg/kg/day on days -7 to -3 and undergo autologous hematopoietic stem cell (HSC) collection. Patients receive high-dose melphalan 140 mg/m\^2 IV for low risk or 200 mg/m\^2 IV for high risk patients over 1 hour on days -2 and -1 and undergo autologous HSC transplantation on day 0.
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
2.9%
1/34 • Number of events 1
|
0.00%
0/55
|
|
Cardiac disorders
Cardiac disorder
|
0.00%
0/34
|
1.8%
1/55 • Number of events 1
|
|
Cardiac disorders
Myocardial ischemia
|
2.9%
1/34 • Number of events 1
|
0.00%
0/55
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/34
|
1.8%
1/55 • Number of events 1
|
|
Cardiac disorders
Ventricular fibrillation
|
2.9%
1/34 • Number of events 1
|
0.00%
0/55
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/34
|
1.8%
1/55 • Number of events 1
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.00%
0/34
|
1.8%
1/55 • Number of events 1
|
|
General disorders
Disease progression
|
0.00%
0/34
|
1.8%
1/55 • Number of events 1
|
|
General disorders
Sudden death
|
2.9%
1/34 • Number of events 1
|
0.00%
0/55
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/34
|
1.8%
1/55 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
2.9%
1/34 • Number of events 1
|
1.8%
1/55 • Number of events 1
|
|
Infections and infestations
Sepsis
|
2.9%
1/34 • Number of events 1
|
1.8%
1/55 • Number of events 1
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/34
|
1.8%
1/55 • Number of events 1
|
|
Investigations
Creatinine increased
|
0.00%
0/34
|
1.8%
1/55 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/34
|
1.8%
1/55 • Number of events 1
|
|
Nervous system disorders
Ischemia cerebrovascular
|
2.9%
1/34 • Number of events 1
|
0.00%
0/55
|
|
Nervous system disorders
Syncope
|
2.9%
1/34 • Number of events 1
|
0.00%
0/55
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/34
|
1.8%
1/55 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.9%
1/34 • Number of events 1
|
0.00%
0/55
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/34
|
1.8%
1/55 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/34
|
3.6%
2/55 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
0.00%
0/34
|
1.8%
1/55 • Number of events 1
|
|
Vascular disorders
Hypotension
|
0.00%
0/34
|
3.6%
2/55 • Number of events 2
|
|
Vascular disorders
Thrombosis
|
5.9%
2/34 • Number of events 2
|
1.8%
1/55 • Number of events 1
|
Other adverse events
| Measure |
Low-Dose Melphalan
n=34 participants at risk
Patients receive low-dose melphalan 20 mg/m\^2 IV over 15-30 minutes on day 1 or 0.12 mg/kg tablet orally once daily on days 1-7 and dexamethasone 40 mg orally on days 1-4 and 22-25. Treatment repeats every 6 weeks for 10 courses. (Study treatment beyond one year is not allowed.)
|
High-Dose Melphalan + Autologous HSC
n=55 participants at risk
Patients receive filgrastim (G-CSF) 10 mg/kg/day on days -7 to -3 and undergo autologous hematopoietic stem cell (HSC) collection. Patients receive high-dose melphalan 140 mg/m\^2 IV for low risk or 200 mg/m\^2 IV for high risk patients over 1 hour on days -2 and -1 and undergo autologous HSC transplantation on day 0.
|
|---|---|---|
|
Blood and lymphatic system disorders
Blood disorder
|
0.00%
0/34
|
1.8%
1/55 • Number of events 1
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/34
|
58.2%
32/55 • Number of events 33
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
50.0%
17/34 • Number of events 41
|
89.1%
49/55 • Number of events 63
|
|
Blood and lymphatic system disorders
Hemolysis
|
0.00%
0/34
|
1.8%
1/55 • Number of events 1
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/34
|
3.6%
2/55 • Number of events 2
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.00%
0/34
|
1.8%
1/55 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/34
|
9.1%
5/55 • Number of events 7
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/34
|
1.8%
1/55 • Number of events 1
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/34
|
1.8%
1/55 • Number of events 1
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/34
|
1.8%
1/55 • Number of events 1
|
|
Cardiac disorders
Restrictive cardiomyopathy
|
2.9%
1/34 • Number of events 1
|
3.6%
2/55 • Number of events 3
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/34
|
3.6%
2/55 • Number of events 2
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/34
|
1.8%
1/55 • Number of events 2
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/34
|
5.5%
3/55 • Number of events 3
|
|
Eye disorders
Cataract
|
2.9%
1/34 • Number of events 2
|
0.00%
0/55
|
|
Eye disorders
Dry eye syndrome
|
0.00%
0/34
|
1.8%
1/55 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/34
|
1.8%
1/55 • Number of events 1
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/34
|
1.8%
1/55 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/34
|
3.6%
2/55 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhea
|
17.6%
6/34 • Number of events 6
|
45.5%
25/55 • Number of events 27
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/34
|
21.8%
12/55 • Number of events 12
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/34
|
1.8%
1/55 • Number of events 1
|
|
Gastrointestinal disorders
Esophageal pain
|
2.9%
1/34 • Number of events 1
|
0.00%
0/55
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/34
|
1.8%
1/55 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/34
|
3.6%
2/55 • Number of events 2
|
|
Gastrointestinal disorders
Hemorrhoids
|
2.9%
1/34 • Number of events 1
|
0.00%
0/55
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/34
|
7.3%
4/55 • Number of events 4
|
|
Gastrointestinal disorders
Nausea
|
8.8%
3/34 • Number of events 3
|
58.2%
32/55 • Number of events 35
|
|
Gastrointestinal disorders
Oesophagoscopy abnormal
|
0.00%
0/34
|
5.5%
3/55 • Number of events 3
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/34
|
1.8%
1/55 • Number of events 1
|
|
Gastrointestinal disorders
Rectal pain
|
0.00%
0/34
|
1.8%
1/55 • Number of events 1
|
|
Gastrointestinal disorders
Stomach pain
|
2.9%
1/34 • Number of events 1
|
0.00%
0/55
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
2.9%
1/34 • Number of events 1
|
0.00%
0/55
|
|
Gastrointestinal disorders
Vomiting
|
5.9%
2/34 • Number of events 2
|
30.9%
17/55 • Number of events 19
|
|
General disorders
Chest pain
|
2.9%
1/34 • Number of events 1
|
0.00%
0/55
|
|
General disorders
Disease progression
|
2.9%
1/34 • Number of events 1
|
0.00%
0/55
|
|
General disorders
Edema limbs
|
94.1%
32/34 • Number of events 140
|
87.3%
48/55 • Number of events 140
|
|
General disorders
Fatigue
|
97.1%
33/34 • Number of events 178
|
100.0%
55/55 • Number of events 197
|
|
General disorders
Fever
|
2.9%
1/34 • Number of events 1
|
14.5%
8/55 • Number of events 8
|
|
General disorders
General symptom
|
0.00%
0/34
|
1.8%
1/55 • Number of events 1
|
|
General disorders
Ill-defined disorder
|
0.00%
0/34
|
1.8%
1/55 • Number of events 1
|
|
General disorders
Localized edema
|
0.00%
0/34
|
1.8%
1/55 • Number of events 1
|
|
General disorders
Pain
|
0.00%
0/34
|
1.8%
1/55 • Number of events 1
|
|
Infections and infestations
Abdominal infection
|
2.9%
1/34 • Number of events 1
|
0.00%
0/55
|
|
Infections and infestations
Anorectal infection
|
0.00%
0/34
|
1.8%
1/55 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
5.9%
2/34 • Number of events 4
|
0.00%
0/55
|
|
Infections and infestations
Esophageal infection
|
2.9%
1/34 • Number of events 1
|
0.00%
0/55
|
|
Infections and infestations
Gingival infection
|
2.9%
1/34 • Number of events 2
|
0.00%
0/55
|
|
Infections and infestations
Infection
|
8.8%
3/34 • Number of events 5
|
1.8%
1/55 • Number of events 1
|
|
Infections and infestations
Infectious colitis
|
0.00%
0/34
|
1.8%
1/55 • Number of events 1
|
|
Infections and infestations
Infectious meningitis
|
0.00%
0/34
|
1.8%
1/55 • Number of events 1
|
|
Infections and infestations
Joint infection
|
2.9%
1/34 • Number of events 1
|
0.00%
0/55
|
|
Infections and infestations
Lip infection
|
0.00%
0/34
|
1.8%
1/55 • Number of events 1
|
|
Infections and infestations
Lymph gland infection
|
0.00%
0/34
|
1.8%
1/55 • Number of events 1
|
|
Infections and infestations
Nail infection
|
2.9%
1/34 • Number of events 1
|
0.00%
0/55
|
|
Infections and infestations
Pneumonia
|
14.7%
5/34 • Number of events 7
|
7.3%
4/55 • Number of events 5
|
|
Infections and infestations
Sepsis
|
5.9%
2/34 • Number of events 2
|
18.2%
10/55 • Number of events 12
|
|
Infections and infestations
Sinusitis
|
2.9%
1/34 • Number of events 1
|
1.8%
1/55 • Number of events 1
|
|
Infections and infestations
Skin infection
|
11.8%
4/34 • Number of events 4
|
1.8%
1/55 • Number of events 1
|
|
Infections and infestations
Upper aerodigestive tract infection
|
0.00%
0/34
|
1.8%
1/55 • Number of events 1
|
|
Infections and infestations
Upper respiratory infection
|
14.7%
5/34 • Number of events 6
|
3.6%
2/55 • Number of events 2
|
|
Infections and infestations
Urinary tract infection
|
2.9%
1/34 • Number of events 1
|
0.00%
0/55
|
|
Infections and infestations
Vaginal infection
|
2.9%
1/34 • Number of events 2
|
1.8%
1/55 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/34
|
1.8%
1/55 • Number of events 1
|
|
Injury, poisoning and procedural complications
Intraoperative gastrointestinal injury - Appendix
|
2.9%
1/34 • Number of events 1
|
0.00%
0/55
|
|
Injury, poisoning and procedural complications
Intraoperative hepatobiliary injury - Gallbladder
|
0.00%
0/34
|
1.8%
1/55 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
2.9%
1/34 • Number of events 1
|
9.1%
5/55 • Number of events 5
|
|
Investigations
Alkaline phosphatase increased
|
5.9%
2/34 • Number of events 2
|
18.2%
10/55 • Number of events 11
|
|
Investigations
Aspartate aminotransferase increased
|
2.9%
1/34 • Number of events 1
|
9.1%
5/55 • Number of events 5
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/34
|
16.4%
9/55 • Number of events 10
|
|
Investigations
Creatine phosphokinase increased
|
0.00%
0/34
|
1.8%
1/55 • Number of events 2
|
|
Investigations
Creatinine increased
|
17.6%
6/34 • Number of events 15
|
38.2%
21/55 • Number of events 33
|
|
Investigations
INR increased
|
0.00%
0/34
|
1.8%
1/55 • Number of events 1
|
|
Investigations
Leukocyte count decreased
|
26.5%
9/34 • Number of events 20
|
92.7%
51/55 • Number of events 56
|
|
Investigations
Lymphocyte count decreased
|
5.9%
2/34 • Number of events 4
|
5.5%
3/55 • Number of events 5
|
|
Investigations
Neutrophil count decreased
|
23.5%
8/34 • Number of events 18
|
94.5%
52/55 • Number of events 60
|
|
Investigations
Platelet count decreased
|
29.4%
10/34 • Number of events 27
|
94.5%
52/55 • Number of events 65
|
|
Investigations
Weight loss
|
38.2%
13/34 • Number of events 24
|
38.2%
21/55 • Number of events 26
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/34
|
9.1%
5/55 • Number of events 5
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
8.8%
3/34 • Number of events 3
|
5.5%
3/55 • Number of events 4
|
|
Metabolism and nutrition disorders
Blood uric acid increased
|
2.9%
1/34 • Number of events 2
|
1.8%
1/55 • Number of events 2
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/34
|
56.4%
31/55 • Number of events 34
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
0.00%
0/34
|
3.6%
2/55 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
0.00%
0/34
|
9.1%
5/55 • Number of events 5
|
|
Metabolism and nutrition disorders
Serum magnesium decreased
|
0.00%
0/34
|
1.8%
1/55 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
0.00%
0/34
|
1.8%
1/55 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
2.9%
1/34 • Number of events 1
|
16.4%
9/55 • Number of events 12
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
0.00%
0/34
|
1.8%
1/55 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
0.00%
0/34
|
20.0%
11/55 • Number of events 11
|
|
Metabolism and nutrition disorders
Serum sodium increased
|
0.00%
0/34
|
1.8%
1/55 • Number of events 1
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
0.00%
0/34
|
1.8%
1/55 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.9%
1/34 • Number of events 1
|
0.00%
0/55
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.9%
2/34 • Number of events 3
|
1.8%
1/55 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.9%
1/34 • Number of events 2
|
3.6%
2/55 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
2.9%
1/34 • Number of events 1
|
0.00%
0/55
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.9%
1/34 • Number of events 2
|
1.8%
1/55 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.9%
1/34 • Number of events 1
|
0.00%
0/55
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Treatment related secondary malignancy
|
2.9%
1/34 • Number of events 1
|
1.8%
1/55 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
2.9%
1/34 • Number of events 1
|
1.8%
1/55 • Number of events 1
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/34
|
1.8%
1/55 • Number of events 1
|
|
Nervous system disorders
Headache
|
0.00%
0/34
|
1.8%
1/55 • Number of events 1
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
55.9%
19/34 • Number of events 72
|
38.2%
21/55 • Number of events 60
|
|
Nervous system disorders
Syncope
|
8.8%
3/34 • Number of events 6
|
7.3%
4/55 • Number of events 6
|
|
Nervous system disorders
Syncope vasovagal
|
2.9%
1/34 • Number of events 1
|
1.8%
1/55 • Number of events 1
|
|
Psychiatric disorders
Confusion
|
0.00%
0/34
|
1.8%
1/55 • Number of events 1
|
|
Psychiatric disorders
Depression
|
5.9%
2/34 • Number of events 3
|
0.00%
0/55
|
|
Psychiatric disorders
Insomnia
|
5.9%
2/34 • Number of events 3
|
7.3%
4/55 • Number of events 4
|
|
Psychiatric disorders
Psychosis
|
0.00%
0/34
|
1.8%
1/55 • Number of events 1
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/34
|
1.8%
1/55 • Number of events 2
|
|
Renal and urinary disorders
Renal failure
|
11.8%
4/34 • Number of events 5
|
7.3%
4/55 • Number of events 5
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/34
|
1.8%
1/55 • Number of events 1
|
|
Renal and urinary disorders
Urogenital disorder
|
0.00%
0/34
|
1.8%
1/55 • Number of events 1
|
|
Reproductive system and breast disorders
Vaginal inflammation
|
2.9%
1/34 • Number of events 1
|
0.00%
0/55
|
|
Respiratory, thoracic and mediastinal disorders
Apnea
|
0.00%
0/34
|
1.8%
1/55 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.9%
2/34 • Number of events 2
|
0.00%
0/55
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
17.6%
6/34 • Number of events 7
|
20.0%
11/55 • Number of events 14
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/34
|
1.8%
1/55 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/34
|
3.6%
2/55 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/34
|
14.5%
8/55 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
2.9%
1/34 • Number of events 1
|
0.00%
0/55
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.9%
1/34 • Number of events 1
|
12.7%
7/55 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.9%
1/34 • Number of events 1
|
10.9%
6/55 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hemorrhage
|
0.00%
0/34
|
1.8%
1/55 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/34
|
1.8%
1/55 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
2.9%
1/34 • Number of events 1
|
3.6%
2/55 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
2.9%
1/34 • Number of events 1
|
9.1%
5/55 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/34
|
1.8%
1/55 • Number of events 1
|
|
Vascular disorders
Hematoma
|
0.00%
0/34
|
1.8%
1/55 • Number of events 1
|
|
Vascular disorders
Hemorrhage
|
2.9%
1/34 • Number of events 1
|
1.8%
1/55 • Number of events 1
|
|
Vascular disorders
Hypotension
|
11.8%
4/34 • Number of events 4
|
60.0%
33/55 • Number of events 34
|
|
Vascular disorders
Thrombosis
|
2.9%
1/34 • Number of events 1
|
7.3%
4/55 • Number of events 4
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place