Trial Outcomes & Findings for Tandem Auto Transplantation in Myeloma Patients With <12 Months of Prior Treatment (NCT NCT01548573)
NCT ID: NCT01548573
Last Updated: 2017-06-14
Results Overview
To determine whether, in comparison to Total Therapy II, the median Event-Free Survival (EFS) can be increased from 4.8 years to 7.2 years, which represents an increase in median EFS of approximately 50%, based on an intent-to-treat analysis.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
19 participants
Primary outcome timeframe
8 years
Results posted on
2017-06-14
Participant Flow
Participant milestones
| Measure |
Tandem Transplant in MM <12 Mos of Prior Treatment
This was a single arm study for myeloma patients with \<12 months of prior treatment to determine whether the incorporation of bortezomib into a tandem transplant regimen followed by 2 years of maintenance therapy would increase event-free survival.
|
|---|---|
|
Overall Study
STARTED
|
19
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Tandem Transplant in MM <12 Mos of Prior Treatment
This was a single arm study for myeloma patients with \<12 months of prior treatment to determine whether the incorporation of bortezomib into a tandem transplant regimen followed by 2 years of maintenance therapy would increase event-free survival.
|
|---|---|
|
Overall Study
Death
|
3
|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
Enrollment halted prematurely. Study met stopping rules. Outcomes will not be tracked and published
Baseline characteristics by cohort
| Measure |
Tandem Transplant in MM <12 Mos of Prior Treatment
n=19 Participants
This was a single arm study for myeloma patients with \<12 months of prior treatment to determine whether the incorporation of bortezomib into a tandem transplant regimen followed by 2 years of maintenance therapy would increase event-free survival.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants • Enrollment halted prematurely. Study met stopping rules. Outcomes will not be tracked and published
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants • Enrollment halted prematurely. Study met stopping rules. Outcomes will not be tracked and published
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants • Enrollment halted prematurely. Study met stopping rules. Outcomes will not be tracked and published
|
|
Age, Continuous
|
59.4 years
n=5 Participants • Enrollment halted prematurely. Study met stopping rules. Outcomes will not be tracked and published
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants • Enrollment halted prematurely. Study met stopping rules. Outcomes will not be tracked and published.
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants • Enrollment halted prematurely. Study met stopping rules. Outcomes will not be tracked and published.
|
|
Region of Enrollment
United States
|
19 participants
n=5 Participants • Enrollment halted prematurely. Study met stopping rules. Outcomes will not be tracked and published
|
PRIMARY outcome
Timeframe: 8 yearsPopulation: Enrollment halted prematurely. Study met stopping rules (3 or more of the first 20 participants died due to treatment-related toxicity). Data for outcome measure 1 were not collected.
To determine whether, in comparison to Total Therapy II, the median Event-Free Survival (EFS) can be increased from 4.8 years to 7.2 years, which represents an increase in median EFS of approximately 50%, based on an intent-to-treat analysis.
Outcome measures
| Measure |
Tandem Autologous Stem Cell Transplant
Induction and PBSC Collection:1 cycle of combination D-PACE (and peripheral blood stem cell collection. After collection, participants may receive interim dexamethasone at 20mg days 1-4 every 14 days.
Transplant 1: 6 weeks after first day of D-PACE , but can occur as early as 4 weeks and as late as 6 months. Once recovered, participants start thalidomide daily and dexamethasone x 4 days every 21 days.
Transplant 2: 8 weeks-6 months after the first transplant, participants will have second transplant. Once recovered, participants start thalidomide daily and dexamethasone x 4 days every 21 days.
Consolidation Phase (if administered): 4 weeks-4 months after second transplant, participants may receive consolidation chemotherapy.
Maintenance Phase year 1 and 2:The first year of maintenance will commence between 6 weeks-6 months after consolidation or 4 weeks-6 months after transplant if consolidation is skipped.
DP
|
|---|---|
|
Event-Free Survival (EFS)
|
0
|
PRIMARY outcome
Timeframe: 5 yearsPopulation: Enrollment halted prematurely. Study met stopping rules (3 or more of the first 20 participants died due to treatment-related toxicity). Data for outcome measure 2 were not collected.
To determine whether repeated bone marrow samples analyzed for gene expression profiling (GEP) can identify genes related to drug resistance in myeloma. The drug resistant genes or the gene products might then be targeted specifically to eradicate myeloma cells surviving tandem transplantation.
Outcome measures
| Measure |
Tandem Autologous Stem Cell Transplant
Induction and PBSC Collection:1 cycle of combination D-PACE (and peripheral blood stem cell collection. After collection, participants may receive interim dexamethasone at 20mg days 1-4 every 14 days.
Transplant 1: 6 weeks after first day of D-PACE , but can occur as early as 4 weeks and as late as 6 months. Once recovered, participants start thalidomide daily and dexamethasone x 4 days every 21 days.
Transplant 2: 8 weeks-6 months after the first transplant, participants will have second transplant. Once recovered, participants start thalidomide daily and dexamethasone x 4 days every 21 days.
Consolidation Phase (if administered): 4 weeks-4 months after second transplant, participants may receive consolidation chemotherapy.
Maintenance Phase year 1 and 2:The first year of maintenance will commence between 6 weeks-6 months after consolidation or 4 weeks-6 months after transplant if consolidation is skipped.
DP
|
|---|---|
|
Identification of Drug Resistant Genes
|
0
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Enrollment halted prematurely. Study met stopping rules (3 or more of the first 20 participants died due to treatment-related toxicity). Data for outcome measure 3 were not collected.
To determine whether bortezomib, thalidomide and dexamethasone with transplant 1 and velcade/gemcitabine with transplant 2 can be safely incorporated into well-tested pre-transplant regimens of high-dose melphalan and carmustine/melphalan in doses equivalent to the BEAM(BCNU, etoposide, arabinoside, melphalan)regimen. Treatment-related toxicities will be compared to those reported in the literature using similar intensive approaches.
Outcome measures
| Measure |
Tandem Autologous Stem Cell Transplant
Induction and PBSC Collection:1 cycle of combination D-PACE (and peripheral blood stem cell collection. After collection, participants may receive interim dexamethasone at 20mg days 1-4 every 14 days.
Transplant 1: 6 weeks after first day of D-PACE , but can occur as early as 4 weeks and as late as 6 months. Once recovered, participants start thalidomide daily and dexamethasone x 4 days every 21 days.
Transplant 2: 8 weeks-6 months after the first transplant, participants will have second transplant. Once recovered, participants start thalidomide daily and dexamethasone x 4 days every 21 days.
Consolidation Phase (if administered): 4 weeks-4 months after second transplant, participants may receive consolidation chemotherapy.
Maintenance Phase year 1 and 2:The first year of maintenance will commence between 6 weeks-6 months after consolidation or 4 weeks-6 months after transplant if consolidation is skipped.
DP
|
|---|---|
|
Number of Grade 3 Non-hematologic and Grade 4 Hematologic Serious Adverse Events Associated With the Addition of Bortezomib, Thalidomide, and Dexamethasone Into Autologous Transplant Regimens.
|
0
|
SECONDARY outcome
Timeframe: 10 yearsPopulation: Enrollment halted prematurely. Study met stopping rules (3 or more of the first 20 participants died due to treatment-related toxicity). Data for outcome measure 4 were not collected.
To determine the median overall survival based on an intent-to-treat analysis, which should exceed 10 years, based on the projected 10-year survival of Total Therapy III, keeping in mind that participants are included in this protocol with up to 12 months of prior therapy.
Outcome measures
| Measure |
Tandem Autologous Stem Cell Transplant
Induction and PBSC Collection:1 cycle of combination D-PACE (and peripheral blood stem cell collection. After collection, participants may receive interim dexamethasone at 20mg days 1-4 every 14 days.
Transplant 1: 6 weeks after first day of D-PACE , but can occur as early as 4 weeks and as late as 6 months. Once recovered, participants start thalidomide daily and dexamethasone x 4 days every 21 days.
Transplant 2: 8 weeks-6 months after the first transplant, participants will have second transplant. Once recovered, participants start thalidomide daily and dexamethasone x 4 days every 21 days.
Consolidation Phase (if administered): 4 weeks-4 months after second transplant, participants may receive consolidation chemotherapy.
Maintenance Phase year 1 and 2:The first year of maintenance will commence between 6 weeks-6 months after consolidation or 4 weeks-6 months after transplant if consolidation is skipped.
DP
|
|---|---|
|
Overall Survival
|
0
|
Adverse Events
Tandem Transplant in MM <12 Mos of Prior Treatment
Serious events: 13 serious events
Other events: 19 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Tandem Transplant in MM <12 Mos of Prior Treatment
n=19 participants at risk
This was a single arm study for myeloma patients with \<12 months of prior treatment to determine whether the incorporation of bortezomib into a tandem transplant regimen followed by 2 years of maintenance therapy would increase event-free survival.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
5.3%
1/19 • Number of events 1
|
|
Gastrointestinal disorders
Cholecystitis
|
5.3%
1/19 • Number of events 1
|
|
Nervous system disorders
Stoke secondary to cardio-embolism
|
5.3%
1/19 • Number of events 1
|
|
Infections and infestations
Sepsis
|
5.3%
1/19 • Number of events 1
|
|
General disorders
Fever
|
15.8%
3/19 • Number of events 3
|
|
Cardiac disorders
Chest pain, air embolism
|
5.3%
1/19 • Number of events 1
|
|
General disorders
Neutropenic fever
|
10.5%
2/19 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.3%
1/19 • Number of events 1
|
|
Cardiac disorders
Myocardial infarction
|
5.3%
1/19 • Number of events 1
|
|
General disorders
Malaise and abrupt chest pain
|
5.3%
1/19 • Number of events 1
|
|
General disorders
Neutropenic fever, abdominal pain, and loose stools
|
5.3%
1/19 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress, fevers, and pneumonia
|
5.3%
1/19 • Number of events 1
|
|
Gastrointestinal disorders
Nausea, and abdominal pain
|
5.3%
1/19 • Number of events 1
|
|
Blood and lymphatic system disorders
Nausea, failure-to-thrive, and line-associated deep vein thrombosis
|
5.3%
1/19 • Number of events 1
|
|
Cardiac disorders
Atrial Fibrillation with RVR
|
10.5%
2/19 • Number of events 2
|
|
General disorders
Hypoxia, fever, pulmonary infiltrates with nodules, and C Diff + diarrhea
|
5.3%
1/19 • Number of events 1
|
|
Infections and infestations
Viral pneumonia
|
5.3%
1/19 • Number of events 1
|
|
General disorders
Chills, cough, throat pain, dyspnea. Mucositis. + hMPV. Engraftment syndrome
|
5.3%
1/19 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Severe back pain
|
5.3%
1/19 • Number of events 1
|
|
Cardiac disorders
Pneumonia, Atrial fib w/ cardioversion
|
5.3%
1/19 • Number of events 1
|
|
Renal and urinary disorders
Acute kidney injury, uncontrolled hypertension, thrombotic microangiopathy
|
5.3%
1/19 • Number of events 1
|
Other adverse events
| Measure |
Tandem Transplant in MM <12 Mos of Prior Treatment
n=19 participants at risk
This was a single arm study for myeloma patients with \<12 months of prior treatment to determine whether the incorporation of bortezomib into a tandem transplant regimen followed by 2 years of maintenance therapy would increase event-free survival.
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
5.3%
1/19 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal Pain/discomfort LLQ
|
5.3%
1/19 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal Pain/discomfort RUQ
|
5.3%
1/19 • Number of events 1
|
|
Investigations
Activated PTT prolonged
|
5.3%
1/19 • Number of events 2
|
|
Renal and urinary disorders
Acute kidney injury
|
5.3%
1/19 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Adult Respiratory Distress Syndrome
|
10.5%
2/19 • Number of events 2
|
|
Nervous system disorders
Akathisia (restless feet)
|
5.3%
1/19 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
21.1%
4/19 • Number of events 4
|
|
Investigations
Allergic reaction during PBSC Collection
|
5.3%
1/19 • Number of events 1
|
|
Investigations
ALT increased
|
26.3%
5/19 • Number of events 6
|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
19/19 • Number of events 65
|
|
Blood and lymphatic system disorders
Anemia (Hemolytic)
|
5.3%
1/19 • Number of events 1
|
|
General disorders
Ankle edema
|
5.3%
1/19 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia
|
26.3%
5/19 • Number of events 8
|
|
Psychiatric disorders
Anxiety
|
5.3%
1/19 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
aspiration
|
5.3%
1/19 • Number of events 1
|
|
Investigations
AST increased
|
21.1%
4/19 • Number of events 4
|
|
Cardiac disorders
Atrial fibrillation
|
10.5%
2/19 • Number of events 3
|
|
Cardiac disorders
Atrial Fibrillation with RVR
|
5.3%
1/19 • Number of events 1
|
|
Cardiac disorders
Atrial flutter
|
5.3%
1/19 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
21.1%
4/19 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Bilateral Calf Pain at time of engraftment
|
5.3%
1/19 • Number of events 1
|
|
General disorders
Bilateral edema in limbs
|
5.3%
1/19 • Number of events 1
|
|
General disorders
Bleeding at port site
|
5.3%
1/19 • Number of events 1
|
|
Gastrointestinal disorders
Bleeding from hemorrhoids
|
5.3%
1/19 • Number of events 1
|
|
Gastrointestinal disorders
Bloating
|
15.8%
3/19 • Number of events 3
|
|
Eye disorders
Blurred vision
|
10.5%
2/19 • Number of events 2
|
|
Blood and lymphatic system disorders
Bone marrow hypocellularity
|
5.3%
1/19 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
10.5%
2/19 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Bone/joint pain
|
5.3%
1/19 • Number of events 1
|
|
Cardiac disorders
Bradycardia
|
5.3%
1/19 • Number of events 1
|
|
Injury, poisoning and procedural complications
Bruising on abdomen and arms
|
5.3%
1/19 • Number of events 1
|
|
Infections and infestations
Catheter related infection
|
5.3%
1/19 • Number of events 1
|
|
Infections and infestations
Catheter related infection: enterococcal (vanc sensitive)
|
10.5%
2/19 • Number of events 2
|
|
Infections and infestations
Catheter-related infection
|
5.3%
1/19 • Number of events 1
|
|
Infections and infestations
catheter-related infection (gram+ cocci)
|
5.3%
1/19 • Number of events 1
|
|
Infections and infestations
Catheter-related infection (VRE)
|
5.3%
1/19 • Number of events 1
|
|
Infections and infestations
Catheter-related infection: enterococcal (vanc sensitive)
|
5.3%
1/19 • Number of events 1
|
|
Gastrointestinal disorders
C-Diff colitis
|
5.3%
1/19 • Number of events 1
|
|
Cardiac disorders
chest pain-cardiac
|
5.3%
1/19 • Number of events 1
|
|
Hepatobiliary disorders
Cholecystitis (w/ gallstone present)
|
5.3%
1/19 • Number of events 1
|
|
Infections and infestations
CMV Reactivation
|
5.3%
1/19 • Number of events 1
|
|
Infections and infestations
Coag neg staph bacteremia x 3
|
5.3%
1/19 • Number of events 1
|
|
Gastrointestinal disorders
Colitis
|
5.3%
1/19 • Number of events 1
|
|
Gastrointestinal disorders
Colitis (C-Diff)
|
5.3%
1/19 • Number of events 1
|
|
Psychiatric disorders
Confusion
|
5.3%
1/19 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
36.8%
7/19 • Number of events 14
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.3%
1/19 • Number of events 1
|
|
Investigations
Creatinine increased
|
10.5%
2/19 • Number of events 4
|
|
Immune system disorders
Cytokine release syndrome
|
5.3%
1/19 • Number of events 1
|
|
Psychiatric disorders
Delirium
|
15.8%
3/19 • Number of events 3
|
|
Gastrointestinal disorders
Diarrhea
|
52.6%
10/19 • Number of events 11
|
|
Gastrointestinal disorders
Diarrhea (c diff pos)
|
15.8%
3/19 • Number of events 4
|
|
Gastrointestinal disorders
Diarrhea (C Diff Neg)
|
42.1%
8/19 • Number of events 8
|
|
Gastrointestinal disorders
Diarrhea (C Diff)
|
10.5%
2/19 • Number of events 3
|
|
Gastrointestinal disorders
Diarrhea/loose stools
|
5.3%
1/19 • Number of events 1
|
|
General disorders
Dizziness
|
42.1%
8/19 • Number of events 10
|
|
General disorders
Dizziness (orthostatic hypotension)
|
5.3%
1/19 • Number of events 1
|
|
Gastrointestinal disorders
Dry mouth
|
10.5%
2/19 • Number of events 2
|
|
Nervous system disorders
Dygeusia (abnormal taste)
|
5.3%
1/19 • Number of events 1
|
|
Nervous system disorders
Dysgeusia
|
5.3%
1/19 • Number of events 1
|
|
Nervous system disorders
Dysgeusia (altered taste)
|
5.3%
1/19 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dysnea
|
5.3%
1/19 • Number of events 1
|
|
Gastrointestinal disorders
Dysphagia
|
10.5%
2/19 • Number of events 2
|
|
Gastrointestinal disorders
Dyspnea
|
42.1%
8/19 • Number of events 12
|
|
Ear and labyrinth disorders
Ear Pain
|
5.3%
1/19 • Number of events 1
|
|
General disorders
Edema
|
5.3%
1/19 • Number of events 1
|
|
General disorders
Edema (feet)
|
5.3%
1/19 • Number of events 1
|
|
General disorders
Edema in left lower ankle
|
5.3%
1/19 • Number of events 1
|
|
General disorders
Edema Limbs
|
5.3%
1/19 • Number of events 1
|
|
General disorders
Edema limbs (bilateral)
|
5.3%
1/19 • Number of events 1
|
|
General disorders
Edema limbs (legs)
|
5.3%
1/19 • Number of events 1
|
|
General disorders
Engraftment fever
|
5.3%
1/19 • Number of events 1
|
|
Blood and lymphatic system disorders
Engraftment fevers
|
5.3%
1/19 • Number of events 1
|
|
General disorders
Engraftment fevers controlled with steroids
|
5.3%
1/19 • Number of events 1
|
|
Immune system disorders
Engraftment syndrome
|
10.5%
2/19 • Number of events 2
|
|
Gastrointestinal disorders
Enterocolitis
|
5.3%
1/19 • Number of events 1
|
|
Gastrointestinal disorders
Esophagitis
|
5.3%
1/19 • Number of events 1
|
|
Gastrointestinal disorders
Esophagitis (CMV related)
|
5.3%
1/19 • Number of events 1
|
|
General disorders
Fatigue
|
68.4%
13/19 • Number of events 26
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
52.6%
10/19 • Number of events 10
|
|
General disorders
Fever
|
5.3%
1/19 • Number of events 1
|
|
General disorders
Fever (non-neutropenic)
|
26.3%
5/19 • Number of events 6
|
|
Vascular disorders
Flushing
|
5.3%
1/19 • Number of events 1
|
|
General disorders
Gait Disturbance
|
5.3%
1/19 • Number of events 1
|
|
General disorders
Gait disturbance (d/t dizziness)
|
5.3%
1/19 • Number of events 1
|
|
Hepatobiliary disorders
Gallbladder sludge
|
5.3%
1/19 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis
|
5.3%
1/19 • Number of events 2
|
|
Gastrointestinal disorders
Gastroenteritis
|
5.3%
1/19 • Number of events 1
|
|
Gastrointestinal disorders
Gastro-esophageal reflux
|
10.5%
2/19 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
15.8%
3/19 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Generalized bone pain
|
5.3%
1/19 • Number of events 1
|
|
Gastrointestinal disorders
GERD with Barrett's esophagus
|
5.3%
1/19 • Number of events 1
|
|
Psychiatric disorders
Hallucinations (with voriconazole)
|
5.3%
1/19 • Number of events 1
|
|
Nervous system disorders
Hand tremor
|
5.3%
1/19 • Number of events 1
|
|
Nervous system disorders
Headache
|
26.3%
5/19 • Number of events 7
|
|
Nervous system disorders
Headache with dexamethasone
|
5.3%
1/19 • Number of events 1
|
|
Infections and infestations
HHV 6 viremia reactivation
|
5.3%
1/19 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Hip pain
|
5.3%
1/19 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
5.3%
1/19 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
5.3%
1/19 • Number of events 14
|
|
Metabolism and nutrition disorders
Hyperglycemia (Dex)
|
47.4%
9/19 • Number of events 15
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis (excessive perspiration)
|
5.3%
1/19 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypernatremia
|
21.1%
4/19 • Number of events 4
|
|
Vascular disorders
Hypertension
|
15.8%
3/19 • Number of events 5
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
10.5%
2/19 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
36.8%
7/19 • Number of events 9
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
94.7%
18/19 • Number of events 42
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
5.3%
1/19 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypokalemia
|
63.2%
12/19 • Number of events 22
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
5.3%
1/19 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Hyponatremia
|
31.6%
6/19 • Number of events 7
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
84.2%
16/19 • Number of events 31
|
|
Vascular disorders
Hypotension
|
26.3%
5/19 • Number of events 5
|
|
Vascular disorders
Hypotension with PBSC infusion
|
5.3%
1/19 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
26.3%
5/19 • Number of events 5
|
|
General disorders
Infusion Site Extravasation w bruising, no pain
|
5.3%
1/19 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
5.3%
1/19 • Number of events 1
|
|
Psychiatric disorders
Insomnia (Dex)
|
26.3%
5/19 • Number of events 5
|
|
Metabolism and nutrition disorders
Iron overload
|
5.3%
1/19 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Joint pain right knee
|
5.3%
1/19 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
joint pains in right hip and shoulder
|
5.3%
1/19 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
5.3%
1/19 • Number of events 1
|
|
Infections and infestations
Laryngitis
|
5.3%
1/19 • Number of events 1
|
|
Nervous system disorders
Left hemiparesis
|
5.3%
1/19 • Number of events 1
|
|
Injury, poisoning and procedural complications
Left Rib Fracture
|
5.3%
1/19 • Number of events 1
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
5.3%
1/19 • Number of events 1
|
|
Infections and infestations
Lip infection (HSV)
|
5.3%
1/19 • Number of events 1
|
|
General disorders
Localized edema (leg)
|
5.3%
1/19 • Number of events 1
|
|
General disorders
Localized edema (right leg) w/out DVT
|
5.3%
1/19 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Low back and hip pain
|
5.3%
1/19 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Lower back pain
|
10.5%
2/19 • Number of events 2
|
|
Infections and infestations
Lung infection: fungal pneumonia
|
5.3%
1/19 • Number of events 1
|
|
Infections and infestations
Lung infection: left lower lobe consolidation
|
5.3%
1/19 • Number of events 1
|
|
Infections and infestations
Lung infection: pneumonia
|
10.5%
2/19 • Number of events 2
|
|
Infections and infestations
Lung infection: pneumonia (hMPV and staph)
|
5.3%
1/19 • Number of events 1
|
|
Infections and infestations
Lung infection: Pulmonary infiltrates with nodules
|
5.3%
1/19 • Number of events 1
|
|
Infections and infestations
Lung infection: RSV Pneumonia
|
5.3%
1/19 • Number of events 1
|
|
Infections and infestations
Lung Infection: serratia marcescens
|
5.3%
1/19 • Number of events 1
|
|
Infections and infestations
Lung infection: viral pneumonia
|
5.3%
1/19 • Number of events 1
|
|
Infections and infestations
Lung infections: CMV pneumonia
|
5.3%
1/19 • Number of events 1
|
|
Investigations
Lymphocyte count decreased
|
100.0%
19/19 • Number of events 31
|
|
Infections and infestations
Lymphopenic fever
|
5.3%
1/19 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Maculopapular rash
|
5.3%
1/19 • Number of events 1
|
|
General disorders
Malaise
|
5.3%
1/19 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Minor left leg pain
|
5.3%
1/19 • Number of events 1
|
|
Gastrointestinal disorders
Mucositis
|
5.3%
1/19 • Number of events 1
|
|
Gastrointestinal disorders
Mucositis (morphine prn)
|
5.3%
1/19 • Number of events 1
|
|
Gastrointestinal disorders
Mucositis (oral)
|
5.3%
1/19 • Number of events 1
|
|
Gastrointestinal disorders
Mucositis (oral) requiring TPN
|
5.3%
1/19 • Number of events 1
|
|
Gastrointestinal disorders
Mucositis oral
|
21.1%
4/19 • Number of events 7
|
|
Gastrointestinal disorders
Mucositis oral (cvn + pca narcotics)
|
5.3%
1/19 • Number of events 1
|
|
General disorders
Multi-organ failure
|
5.3%
1/19 • Number of events 1
|
|
Cardiac disorders
myocardial infarction
|
5.3%
1/19 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.3%
1/19 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
57.9%
11/19 • Number of events 24
|
|
Gastrointestinal disorders
Nausea with dexamethasone
|
5.3%
1/19 • Number of events 1
|
|
Gastrointestinal disorders
Nausea/vomiting (from post-nasal drip)
|
5.3%
1/19 • Number of events 1
|
|
Gastrointestinal disorders
Nausea/Vomiting (TPN)
|
5.3%
1/19 • Number of events 1
|
|
General disorders
Neutropenic fever
|
5.3%
1/19 • Number of events 1
|
|
Investigations
Neutrophil count decreased
|
5.3%
1/19 • Number of events 1
|
|
General disorders
Non-cardiac chest pain
|
10.5%
2/19 • Number of events 2
|
|
General disorders
Non-cardiac pleuritic chest pain
|
5.3%
1/19 • Number of events 1
|
|
Gastrointestinal disorders
Oral pain (tongue lesion)
|
5.3%
1/19 • Number of events 1
|
|
Vascular disorders
Orthostatic Hypotension
|
5.3%
1/19 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Other, muscle spasms in lower back and neck
|
5.3%
1/19 • Number of events 1
|
|
Metabolism and nutrition disorders
Other: Chloride increased
|
5.3%
1/19 • Number of events 1
|
|
Infections and infestations
Other: CMV reactivation
|
5.3%
1/19 • Number of events 1
|
|
Metabolism and nutrition disorders
Other: CO2 decreased
|
5.3%
1/19 • Number of events 1
|
|
General disorders
Other: Failure to thrive
|
10.5%
2/19 • Number of events 2
|
|
Vascular disorders
Other: Left carotid artery stenosis
|
5.3%
1/19 • Number of events 1
|
|
Blood and lymphatic system disorders
Other: Platelet refractoriness
|
5.3%
1/19 • Number of events 1
|
|
Investigations
Other: sub-therapeutic INR
|
5.3%
1/19 • Number of events 1
|
|
Investigations
Other: Vanc sensitive Enterococcal + coag neg staph bacteremia
|
5.3%
1/19 • Number of events 1
|
|
Infections and infestations
Other: VRE + coag neg staph bacteremia (Enterococcus faecium)
|
5.3%
1/19 • Number of events 1
|
|
Infections and infestations
Otitis media
|
5.3%
1/19 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain
|
10.5%
2/19 • Number of events 2
|
|
General disorders
Pain at port and catheter site
|
5.3%
1/19 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in both elbows
|
5.3%
1/19 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity (left lower arm)
|
5.3%
1/19 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in hips and left lower leg
|
5.3%
1/19 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in lower back
|
5.3%
1/19 • Number of events 1
|
|
Cardiac disorders
Palpitations
|
5.3%
1/19 • Number of events 1
|
|
Infections and infestations
Pansinusitis
|
5.3%
1/19 • Number of events 1
|
|
Nervous system disorders
Paresthesia
|
5.3%
1/19 • Number of events 1
|
|
Nervous system disorders
Peripheral Neuropathy
|
21.1%
4/19 • Number of events 7
|
|
Nervous system disorders
Peripheral Neuropathy (feet)
|
5.3%
1/19 • Number of events 2
|
|
Nervous system disorders
Peripheral neuropathy (hands)
|
5.3%
1/19 • Number of events 1
|
|
Nervous system disorders
Peripheral Neuropathy (thal held)
|
5.3%
1/19 • Number of events 1
|
|
Nervous system disorders
Peripheral Neuropathy (thalidomide stopped)
|
5.3%
1/19 • Number of events 1
|
|
Nervous system disorders
Peripheral Neuropathy (toes)
|
5.3%
1/19 • Number of events 1
|
|
Infections and infestations
Pharyngitis
|
5.3%
1/19 • Number of events 1
|
|
Investigations
Platelet count decreased
|
100.0%
19/19 • Number of events 65
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
10.5%
2/19 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
5.3%
1/19 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis (hMPV)
|
5.3%
1/19 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Post-nasal drip
|
5.3%
1/19 • Number of events 1
|
|
Investigations
PTT prolonged
|
5.3%
1/19 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Edema
|
21.1%
4/19 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.5%
2/19 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash - face and neck
|
5.3%
1/19 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.3%
1/19 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure/ARDS
|
5.3%
1/19 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Rib pain
|
5.3%
1/19 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Rt knee joint pain w/ swelling
|
5.3%
1/19 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Scalp Pain
|
5.3%
1/19 • Number of events 1
|
|
Infections and infestations
Sepsis
|
5.3%
1/19 • Number of events 1
|
|
Infections and infestations
Sepsis (Gram Neg)
|
5.3%
1/19 • Number of events 1
|
|
Investigations
Serum amylase increased
|
5.3%
1/19 • Number of events 1
|
|
Cardiac disorders
Sinus bradycardia
|
5.3%
1/19 • Number of events 1
|
|
Nervous system disorders
Somnolence
|
15.8%
3/19 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
10.5%
2/19 • Number of events 2
|
|
Gastrointestinal disorders
Stomach pain
|
5.3%
1/19 • Number of events 1
|
|
Gastrointestinal disorders
Stomach pain (not during dex admin)
|
5.3%
1/19 • Number of events 1
|
|
Nervous system disorders
Stroke
|
5.3%
1/19 • Number of events 1
|
|
General disorders
Swelling of right hand (neg doppler)
|
5.3%
1/19 • Number of events 1
|
|
Nervous system disorders
Syncope
|
10.5%
2/19 • Number of events 2
|
|
Ear and labyrinth disorders
Tinnitus
|
5.3%
1/19 • Number of events 1
|
|
Infections and infestations
Toe infection
|
5.3%
1/19 • Number of events 1
|
|
Nervous system disorders
Tremor
|
5.3%
1/19 • Number of events 1
|
|
Nervous system disorders
Tremor in hands, R> L
|
10.5%
2/19 • Number of events 2
|
|
Renal and urinary disorders
Urinary Frequency
|
5.3%
1/19 • Number of events 1
|
|
Renal and urinary disorders
Urinary Frequency (Nocturnal)
|
5.3%
1/19 • Number of events 1
|
|
Renal and urinary disorders
Urinary Incontinence
|
5.3%
1/19 • Number of events 3
|
|
Infections and infestations
Vancomycin-Resistant Enterococcus
|
10.5%
2/19 • Number of events 2
|
|
Injury, poisoning and procedural complications
Vascular Access Complication (air embolism)
|
5.3%
1/19 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
26.3%
5/19 • Number of events 9
|
|
Investigations
WBC decreased
|
100.0%
19/19 • Number of events 56
|
|
General disorders
Weakness
|
10.5%
2/19 • Number of events 4
|
|
Investigations
Weight Loss
|
15.8%
3/19 • Number of events 4
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place