Trial Outcomes & Findings for A Pilot Study of Autologous T-Cell Transplantation With Vaccine Driven Expansion of Anti-Tumor Effectors After Cytoreductive Therapy in Metastatic Pediatric Sarcomas (NCT NCT00001566)
NCT ID: NCT00001566
Last Updated: 2012-06-15
Results Overview
Immune response was defined as a percent specific lysis of \>10% following challenge with peptide pulsed targets, or interferon gamma production following challenge with peptide pulsed targets \>2-fold that found with no-peptide controls or a proliferation index \>3.0. Tumor specific peptides: Ewings sarcoma Type 1: EF-1 (EWS/FLI-1)\*SSSYGQQN/PSYDSVRRGA,Ewing's Sarcoma Type 2: EF-2 (EWS/FLI-2)\* SSSYGQ/QSSLLAYNT, Alveolar rhabdomyosarcoma: PXFK (PAX3/FKHR)† TIGNGLSPQ/NSIRHNLSL. Non-tumor specific peptide:HPV16E7 MLDLQPETT-MET-9-THR. See protocol link module for additional information re: peptides.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
42 participants
Primary outcome timeframe
20 weeks post vaccination
Results posted on
2012-06-15
Participant Flow
42 patients were enrolled in this study.
Participant milestones
| Measure |
Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy
Patients receive oral indinavir sulfate 350 mg/m\^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10\^6 injection; harvested autologous T cells (minimum dose 1 x 10\^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.
|
|---|---|
|
Overall Study
STARTED
|
42
|
|
Overall Study
Completed Immunotherapy
|
23
|
|
Overall Study
COMPLETED
|
23
|
|
Overall Study
NOT COMPLETED
|
19
|
Reasons for withdrawal
| Measure |
Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy
Patients receive oral indinavir sulfate 350 mg/m\^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10\^6 injection; harvested autologous T cells (minimum dose 1 x 10\^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.
|
|---|---|
|
Overall Study
patients' choice to discontinue protocol
|
3
|
|
Overall Study
stopped after C3 due to symptomatic PD
|
1
|
|
Overall Study
Death
|
13
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
unable to complete initial apheresis
|
1
|
Baseline Characteristics
A Pilot Study of Autologous T-Cell Transplantation With Vaccine Driven Expansion of Anti-Tumor Effectors After Cytoreductive Therapy in Metastatic Pediatric Sarcomas
Baseline characteristics by cohort
| Measure |
Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy
n=42 Participants
Patients receive oral indinavir sulfate 350 mg/m\^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10\^6 injection; harvested autologous T cells (minimum dose 1 x 10\^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.
|
|---|---|
|
Age, Categorical
<=18 years
|
26 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
18.67 years
STANDARD_DEVIATION 8.59 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
40 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
42 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 20 weeks post vaccinationImmune response was defined as a percent specific lysis of \>10% following challenge with peptide pulsed targets, or interferon gamma production following challenge with peptide pulsed targets \>2-fold that found with no-peptide controls or a proliferation index \>3.0. Tumor specific peptides: Ewings sarcoma Type 1: EF-1 (EWS/FLI-1)\*SSSYGQQN/PSYDSVRRGA,Ewing's Sarcoma Type 2: EF-2 (EWS/FLI-2)\* SSSYGQ/QSSLLAYNT, Alveolar rhabdomyosarcoma: PXFK (PAX3/FKHR)† TIGNGLSPQ/NSIRHNLSL. Non-tumor specific peptide:HPV16E7 MLDLQPETT-MET-9-THR. See protocol link module for additional information re: peptides.
Outcome measures
| Measure |
Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy
n=23 Participants
Patients receive oral indinavir sulfate 350 mg/m\^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10\^6 injection; harvested autologous T cells (minimum dose 1 x 10\^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.
|
|---|---|
|
Number of Participants With an Immune Response to Tumor-specific and Non-tumor Specific Peptides During a Period of Immune Reconstitution
Immune response to tumor specific peptides
|
9 Participants
|
|
Number of Participants With an Immune Response to Tumor-specific and Non-tumor Specific Peptides During a Period of Immune Reconstitution
Immune response to non-tumor specific peptides
|
23 Participants
|
PRIMARY outcome
Timeframe: 2 to 6 monthsCD4 counts were measured from peripheral blood using standard flow cytometric techniques at the following timepoints: 2 months post-chemotherapy, 4 months post-chemotherapy and 6 months post-chemotherapy. To be eligible for evaluation for this endpoint, patient much have been \<10 years of age and sustained a CD4 count of \<300 cells/mcl upon completion of standard therapy. Recovery was defined as a CD4 count \> 500 cells/mcl at any timepoint within 6 months of completing chemotherapy.
Outcome measures
| Measure |
Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy
n=16 Participants
Patients receive oral indinavir sulfate 350 mg/m\^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10\^6 injection; harvested autologous T cells (minimum dose 1 x 10\^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.
|
|---|---|
|
The Percent of Patients Who Recover CD4 Counts Within 6 Months of Completion of Chemotherapy
|
12.5 Percentage of participants
|
PRIMARY outcome
Timeframe: 5 yearsImmune responses were measured following 3 sequential influenza vaccines during the same period as the peptide-pulsed dendritic cell vaccines.
Outcome measures
| Measure |
Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy
n=23 Participants
Patients receive oral indinavir sulfate 350 mg/m\^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10\^6 injection; harvested autologous T cells (minimum dose 1 x 10\^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.
|
|---|---|
|
Number of Participants With an Immune Response to the Translocation Breakpoint Peptide
|
9 Participants
|
PRIMARY outcome
Timeframe: 5 yearsPopulation: 12 patients were human leukocyte antigen serotype within HLA-A A serotype group (HLA-A2+) and therefore evaluable for response to E7 peptides.
Immune response was defined as a percent specific lysis of \>10% following challenge with peptide pulsed targets, or interferon gamma production following challenge with peptide pulsed targets \>2-fold that found with no-peptide controls or a proliferation index \>3.0.
Outcome measures
| Measure |
Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy
n=12 Participants
Patients receive oral indinavir sulfate 350 mg/m\^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10\^6 injection; harvested autologous T cells (minimum dose 1 x 10\^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.
|
|---|---|
|
Number of Participants With an Immune Response to Non-Tumor-specific Peptide E7
|
3 Participants
|
PRIMARY outcome
Timeframe: Once per enrollmentImmune response was defined as a percent specific lysis of \>10% following challenge with tumor peptide pulsed targets, or interferon gamma production following challenge with tumor peptide pulsed targets \>2-fold that found with no-peptide controls or a proliferation index \>3.0 to tumor peptide targets.Tumor specific peptides: Ewings sarcoma Type 1: EF-1 (EWS/FLI-1)\*SSSYGQQN/PSYDSVRRGA,Ewing's Sarcoma Type 2: EF-2 (EWS/FLI-2)\* SSSYGQ/QSSLLAYNT, Alveolar rhabdomyosarcoma: PXFK (PAX3/FKHR)† TIGNGLSPQ/NSIRHNLSL. See protocol link module for additional information re: peptides.
Outcome measures
| Measure |
Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy
n=23 Participants
Patients receive oral indinavir sulfate 350 mg/m\^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10\^6 injection; harvested autologous T cells (minimum dose 1 x 10\^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.
|
|---|---|
|
Number of Participants With an Immune Response to Tumor-Specific Peptides at the Time of Presentation
|
5 Participants
|
SECONDARY outcome
Timeframe: 5 yearsOverall survival is defined as the time between the first day of treatment to the day of death.
Outcome measures
| Measure |
Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy
n=42 Participants
Patients receive oral indinavir sulfate 350 mg/m\^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10\^6 injection; harvested autologous T cells (minimum dose 1 x 10\^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.
|
|---|---|
|
Percentage of Participants Overall Survival
|
43 Percentage of participants
|
SECONDARY outcome
Timeframe: 5 yearsEvent free survival is calculated from the date of diagnosis for patients enrolled with newly diagnosed metastatic disease and from the date of the last recurrence detection before enrollment on this study for patients with recurrent disease.
Outcome measures
| Measure |
Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy
n=42 Participants
Patients receive oral indinavir sulfate 350 mg/m\^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10\^6 injection; harvested autologous T cells (minimum dose 1 x 10\^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.
|
|---|---|
|
Percent of Participants: Event Free Survival
|
31 Percentage of participants
|
SECONDARY outcome
Timeframe: 5 yearsHere are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.
Outcome measures
| Measure |
Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy
n=42 Participants
Patients receive oral indinavir sulfate 350 mg/m\^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10\^6 injection; harvested autologous T cells (minimum dose 1 x 10\^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.
|
|---|---|
|
Number of Participants With Adverse Events
|
27 Participants
|
SECONDARY outcome
Timeframe: 5.4 yearsOverall survival is defined as the time between the first day of treatment to the day of death.
Outcome measures
| Measure |
Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy
n=42 Participants
Patients receive oral indinavir sulfate 350 mg/m\^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10\^6 injection; harvested autologous T cells (minimum dose 1 x 10\^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.
|
|---|---|
|
Median Overall Survival
|
4.1 Years
Interval 3.4 to 5.4
|
Adverse Events
Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy
Serious events: 15 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy
n=42 participants at risk
Patients receive oral indinavir sulfate 350 mg/m\^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10\^6 injection; harvested autologous T cells (minimum dose 1 x 10\^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain or cramping
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Anorexia
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Investigations
CPK (Creatine phosphokinase)
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
4.8%
2/42 • Number of events 2 • 5 years
|
|
Vascular disorders
DVT (deep vein thrombosis)
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Investigations
Elevated total bilirubin
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Nervous system disorders
Headache
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Blood and lymphatic system disorders
Hemorrhage
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Investigations
Leukocytes
|
2.4%
1/42 • Number of events 2 • 5 years
|
|
Investigations
Neutropenia
|
7.1%
3/42 • Number of events 4 • 5 years
|
|
Investigations
Neutrophils
|
2.4%
1/42 • Number of events 2 • 5 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.4%
1/42 • Number of events 2 • 5 years
|
|
Skin and subcutaneous tissue disorders
Rash with macules/papules
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Skin and subcutaneous tissue disorders
Skin rash
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
4.8%
2/42 • Number of events 2 • 5 years
|
Other adverse events
| Measure |
Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy
n=42 participants at risk
Patients receive oral indinavir sulfate 350 mg/m\^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10\^6 injection; harvested autologous T cells (minimum dose 1 x 10\^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.
|
|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Abdominal pain
|
4.8%
2/42 • Number of events 5 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Achiness
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
General disorders
Achy
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Acid reflux
|
2.4%
1/42 • Number of events 6 • 5 years
|
|
Skin and subcutaneous tissue disorders
Acne (rash) on chest
|
2.4%
1/42 • Number of events 4 • 5 years
|
|
Metabolism and nutrition disorders
Alkaline phosphate elevated
|
16.7%
7/42 • Number of events 10 • 5 years
|
|
Metabolism and nutrition disorders
ALT (SGPT)
|
2.4%
1/42 • Number of events 5 • 5 years
|
|
Blood and lymphatic system disorders
Anemia
|
14.3%
6/42 • Number of events 9 • 5 years
|
|
Psychiatric disorders
Anxiety
|
4.8%
2/42 • Number of events 2 • 5 years
|
|
Psychiatric disorders
Anxiety symptoms
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Metabolism and nutrition disorders
AST (SGOT)
|
4.8%
2/42 • Number of events 3 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.1%
3/42 • Number of events 7 • 5 years
|
|
Gastrointestinal disorders
Bad taste in mouth
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Bilateral flank pain
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Bitter taste in mouth
|
2.4%
1/42 • Number of events 4 • 5 years
|
|
Injury, poisoning and procedural complications
Bruise
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Chelitis
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
General disorders
Chest tightness
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
General disorders
Chills
|
16.7%
7/42 • Number of events 14 • 5 years
|
|
General disorders
Cold
|
4.8%
2/42 • Number of events 2 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Congestion
|
7.1%
3/42 • Number of events 4 • 5 years
|
|
Gastrointestinal disorders
Constipation
|
4.8%
2/42 • Number of events 3 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.9%
5/42 • Number of events 9 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough (dry)
|
2.4%
1/42 • Number of events 2 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough (mild, intermittent)
|
2.4%
1/42 • Number of events 3 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough nonproductive
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
General disorders
Cranky
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Decreased appetite
|
7.1%
3/42 • Number of events 4 • 5 years
|
|
General disorders
Decreased flexibility swelling left leg
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Metabolism and nutrition disorders
Decreased uric acid
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
Decreased urine output (o/p)
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
19.0%
8/42 • Number of events 10 • 5 years
|
|
Skin and subcutaneous tissue disorders
Discoloration skin (L) hand
|
4.8%
2/42 • Number of events 2 • 5 years
|
|
Nervous system disorders
Dizziness
|
4.8%
2/42 • Number of events 2 • 5 years
|
|
Nervous system disorders
Dizzy
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Eye disorders
Double vision
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Drainage on foot
|
2.4%
1/42 • Number of events 2 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dry cough
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Dry heaves
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Dry lips
|
4.8%
2/42 • Number of events 2 • 5 years
|
|
Skin and subcutaneous tissue disorders
Dry scaly peeling skin
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Skin and subcutaneous tissue disorders
Dry scaly skin
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
9.5%
4/42 • Number of events 5 • 5 years
|
|
Ear and labyrinth disorders
Ear pain/infection
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Ear and labyrinth disorders
Ears ringing
|
2.4%
1/42 • Number of events 4 • 5 years
|
|
Ear and labyrinth disorders
Ears ringing and clogged
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
General disorders
Edema
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
General disorders
Edema media R mid-thigh
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
General disorders
Edema on foot
|
2.4%
1/42 • Number of events 2 • 5 years
|
|
General disorders
Edema, facial
|
4.8%
2/42 • Number of events 2 • 5 years
|
|
Investigations
Elevated creat
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Investigations
Elevated creatin
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Hepatobiliary disorders
Elevated D bili
|
9.5%
4/42 • Number of events 4 • 5 years
|
|
Metabolism and nutrition disorders
Elevated glucose
|
4.8%
2/42 • Number of events 2 • 5 years
|
|
Hepatobiliary disorders
Elevated LFT's (liver function tests)
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Metabolism and nutrition disorders
Elevated magnesium
|
4.8%
2/42 • Number of events 3 • 5 years
|
|
Investigations
Elevated SGOT(serum glutamic oxaloacetic transaminase)
|
19.0%
8/42 • Number of events 8 • 5 years
|
|
Investigations
Elevated SGPT (serum glutamic pyruvic transaminase)
|
23.8%
10/42 • Number of events 14 • 5 years
|
|
Investigations
Elevated BUN
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Investigations
Elevated creatinine
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Emesis
|
4.8%
2/42 • Number of events 7 • 5 years
|
|
Investigations
Eosinophilia
|
31.0%
13/42 • Number of events 33 • 5 years
|
|
Skin and subcutaneous tissue disorders
Erythema
|
4.8%
2/42 • Number of events 3 • 5 years
|
|
Eye disorders
Eye pain
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Eye disorders
Eye swollen
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Eye disorders
Eyes watery
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
General disorders
Fatigue
|
38.1%
16/42 • Number of events 24 • 5 years
|
|
General disorders
Fever
|
28.6%
12/42 • Number of events 25 • 5 years
|
|
General disorders
Fever (by touch)
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
General disorders
Fever (by touch-low grade)
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
General disorders
Fever blister
|
2.4%
1/42 • Number of events 3 • 5 years
|
|
General disorders
Fever-low grade (by touch)
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Flatulence
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
General disorders
flu symptoms
|
7.1%
3/42 • Number of events 8 • 5 years
|
|
General disorders
Flu-like symptoms
|
9.5%
4/42 • Number of events 4 • 5 years
|
|
General disorders
Flush cheeks
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
General disorders
Flush, facial
|
4.8%
2/42 • Number of events 2 • 5 years
|
|
General disorders
Flushed
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
General disorders
Flushed skin
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
General disorders
Flushing
|
4.8%
2/42 • Number of events 3 • 5 years
|
|
General disorders
Foot drop
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Gas build-up
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Gas pains
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
General disorders
Generalized pain
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
General disorders
Glands swoll
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Metabolism and nutrition disorders
Glucosuria
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Gum line bump (L. upper)
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Nervous system disorders
Headache
|
26.2%
11/42 • Number of events 14 • 5 years
|
|
Gastrointestinal disorders
Heartburn
|
4.8%
2/42 • Number of events 7 • 5 years
|
|
Renal and urinary disorders
Hematuria
|
16.7%
7/42 • Number of events 10 • 5 years
|
|
Blood and lymphatic system disorders
Hemoglobin
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Eye disorders
Hemorrhage sclera
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Skin and subcutaneous tissue disorders
Hives
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Vascular disorders
Hot feeling
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Hepatobiliary disorders
Hyperbilirubin
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
7.1%
3/42 • Number of events 3 • 5 years
|
|
Vascular disorders
Hypertension
|
2.4%
1/42 • Number of events 2 • 5 years
|
|
Endocrine disorders
Hyperthyroid
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.4%
1/42 • Number of events 2 • 5 years
|
|
Vascular disorders
Hypotension
|
9.5%
4/42 • Number of events 4 • 5 years
|
|
Endocrine disorders
Hypothyroid
|
4.8%
2/42 • Number of events 2 • 5 years
|
|
Skin and subcutaneous tissue disorders
Impetigo
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Investigations
INC SGOT (serum glutamic oxaloacetic transaminase)
|
2.4%
1/42 • Number of events 2 • 5 years
|
|
Investigations
INC SGPT (serum glutamic pyruvic transaminase)
|
2.4%
1/42 • Number of events 5 • 5 years
|
|
General disorders
Increase fatigue
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Indigestion
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Skin and subcutaneous tissue disorders
Induration
|
2.4%
1/42 • Number of events 2 • 5 years
|
|
Skin and subcutaneous tissue disorders
Induration injection site
|
2.4%
1/42 • Number of events 5 • 5 years
|
|
Infections and infestations
Inf IV site
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Eye disorders
Injection sclera
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
General disorders
Injection reaction
|
16.7%
7/42 • Number of events 38 • 5 years
|
|
Psychiatric disorders
Insomnia
|
7.1%
3/42 • Number of events 4 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Intermittent pain in shaft of R tibia
|
7.1%
3/42 • Number of events 3 • 5 years
|
|
Nervous system disorders
Intermittent H/A (headache)
|
7.1%
3/42 • Number of events 6 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Intermittent cramping legs
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
General disorders
Intermittent fatigue
|
2.4%
1/42 • Number of events 4 • 5 years
|
|
Psychiatric disorders
Intermittent insomnia
|
2.4%
1/42 • Number of events 3 • 5 years
|
|
General disorders
Irritable
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Skin and subcutaneous tissue disorders
Itching
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Skin and subcutaneous tissue disorders
Itching (chest)
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Skin and subcutaneous tissue disorders
Itching/injection site
|
2.4%
1/42 • Number of events 3 • 5 years
|
|
Skin and subcutaneous tissue disorders
Itchy L. leg
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Skin and subcutaneous tissue disorders
Itchy scratch under left eye
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
General disorders
Jaw pain
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
4.8%
2/42 • Number of events 2 • 5 years
|
|
Renal and urinary disorders
Kidney stone
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
General disorders
L anterior chest pain
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
General disorders
Left chest pressure
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Ear and labyrinth disorders
Left ear ringing
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Leg pain
|
4.8%
2/42 • Number of events 2 • 5 years
|
|
Nervous system disorders
Lethargic
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Investigations
Leukocytes
|
2.4%
1/42 • Number of events 7 • 5 years
|
|
Nervous system disorders
Lips numb
|
4.8%
2/42 • Number of events 2 • 5 years
|
|
Gastrointestinal disorders
Loose stool
|
4.8%
2/42 • Number of events 8 • 5 years
|
|
Gastrointestinal disorders
Loose stools
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Ear and labyrinth disorders
Loss of balance
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Metabolism and nutrition disorders
Low albumin
|
7.1%
3/42 • Number of events 3 • 5 years
|
|
Investigations
Low CO2
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Metabolism and nutrition disorders
Low potassium
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Lower back soreness
|
4.8%
2/42 • Number of events 3 • 5 years
|
|
General disorders
Malaise
|
11.9%
5/42 • Number of events 6 • 5 years
|
|
General disorders
Malleolus (pain)
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Minor sore throat
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Muscle aches
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Muscle atrophy
|
2.4%
1/42 • Number of events 3 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.1%
3/42 • Number of events 3 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia-bilateral thighs
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
26.2%
11/42 • Number of events 18 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal drainage
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Nausea
|
28.6%
12/42 • Number of events 24 • 5 years
|
|
Gastrointestinal disorders
Nausea/vomiting
|
4.8%
2/42 • Number of events 2 • 5 years
|
|
Investigations
Neutropenia
|
11.9%
5/42 • Number of events 6 • 5 years
|
|
Investigations
Neutrophils
|
2.4%
1/42 • Number of events 5 • 5 years
|
|
Skin and subcutaneous tissue disorders
Night sweat
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Nose bleed
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Nose congestion
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Nervous system disorders
Numbness in feet and hands
|
4.8%
2/42 • Number of events 3 • 5 years
|
|
Nervous system disorders
Occipital (mild pain)
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Ear and labyrinth disorders
Otitis media
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
General disorders
Pain
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
General disorders
Pain injection site
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
General disorders
Pain R foot
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
General disorders
Pain R hip
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
General disorders
Pain tailbone
|
2.4%
1/42 • Number of events 2 • 5 years
|
|
Skin and subcutaneous tissue disorders
Patchy dry skin/itch trunk
|
2.4%
1/42 • Number of events 2 • 5 years
|
|
General disorders
Perior edema
|
2.4%
1/42 • Number of events 2 • 5 years
|
|
Blood and lymphatic system disorders
Petechiae
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Investigations
Platelets
|
2.4%
1/42 • Number of events 2 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pressure in chest with inhalation
|
2.4%
1/42 • Number of events 3 • 5 years
|
|
General disorders
Pretib edema
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Nervous system disorders
Prickling sensation
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
Proteinuria
|
19.0%
8/42 • Number of events 17 • 5 years
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
7.1%
3/42 • Number of events 3 • 5 years
|
|
Eye disorders
Ptosis
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
General disorders
Puffy face
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Quad muscle soreness
|
2.4%
1/42 • Number of events 4 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Quad/muscle pain
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.5%
4/42 • Number of events 5 • 5 years
|
|
Skin and subcutaneous tissue disorders
Rash, chest
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Skin and subcutaneous tissue disorders
Rash, arm/chs
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Skin and subcutaneous tissue disorders
Rash/redness (top of arm)
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Psychiatric disorders
Restlessness
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
2.4%
1/42 • Number of events 2 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Runny nose
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Scrape on face
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Scratch under left eye
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
General disorders
Shoulder pain
|
2.4%
1/42 • Number of events 2 • 5 years
|
|
Skin and subcutaneous tissue disorders
Skin peeling
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Skin and subcutaneous tissue disorders
Skin sensation
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Sore mouth
|
2.4%
1/42 • Number of events 2 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
7.1%
3/42 • Number of events 4 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Soreness under ribs
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Soreness/achiness
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Stiff neck
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Stomach ache
|
7.1%
3/42 • Number of events 4 • 5 years
|
|
Gastrointestinal disorders
Stomach burning
|
2.4%
1/42 • Number of events 3 • 5 years
|
|
Gastrointestinal disorders
Stomach pain
|
7.1%
3/42 • Number of events 3 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Stuffy nose
|
4.8%
2/42 • Number of events 2 • 5 years
|
|
Eye disorders
Stye (L) lower corner eye
|
4.8%
2/42 • Number of events 2 • 5 years
|
|
Skin and subcutaneous tissue disorders
Sweating
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
General disorders
Swell ankle
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
General disorders
Swell tongue
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
General disorders
Swelling lip
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
General disorders
Swelling-lower extremity
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Cardiac disorders
Tachycardia
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Throat pain
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
16.7%
7/42 • Number of events 9 • 5 years
|
|
General disorders
Tiredness
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Skin and subcutaneous tissue disorders
Ulceration (R) heel
|
2.4%
1/42 • Number of events 4 • 5 years
|
|
Skin and subcutaneous tissue disorders
Ulceration L heel
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Upset stomach
|
7.1%
3/42 • Number of events 3 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
URI (upper respiratory infection)
|
7.1%
3/42 • Number of events 4 • 5 years
|
|
Vascular disorders
Vascular
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Vomiting
|
23.8%
10/42 • Number of events 15 • 5 years
|
|
General disorders
Weakness
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Weakness (L. leg)
|
2.4%
1/42 • Number of events 2 • 5 years
|
|
Investigations
Weight gain
|
14.3%
6/42 • Number of events 6 • 5 years
|
|
Investigations
Weight loss
|
7.1%
3/42 • Number of events 3 • 5 years
|
|
General disorders
Decreased L leg flexibility
|
4.8%
2/42 • Number of events 2 • 5 years
|
|
Metabolism and nutrition disorders
Elevated uric acid
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Metabolism and nutrition disorders
Elev phos
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Skin and subcutaneous tissue disorders
Itchy legs
|
2.4%
1/42 • Number of events 4 • 5 years
|
|
General disorders
Pain, legs
|
2.4%
1/42 • Number of events 1 • 5 years
|
|
Investigations
Elevated total bilirubin
|
7.1%
3/42 • Number of events 3 • 5 years
|
Additional Information
Crystal Mackall, M.D.
National Cancer Institute (NCI), National Institutes of Health (NIH)
Phone: 301-402-5940
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place