Trial Outcomes & Findings for Genetically Modified Therapeutic Autologous Lymphocytes Followed by Aldesleukin in Treating Patients With Stage III or Metastatic Melanoma (NCT NCT01740557)
NCT ID: NCT01740557
Last Updated: 2024-10-08
Results Overview
Response will be defined as a 50% or greater decrease in the tumor's linear dimension post treatment, compared to baseline. Response will be evaluated by positron emission tomography or computed tomography imaging.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
10 participants
Primary outcome timeframe
Up to 1 year
Results posted on
2024-10-08
Participant Flow
Participant milestones
| Measure |
Treatment (Genetically Modified T-cells, High-dose Aldesleukin
Participants receive cyclophosphamide IV over 2 hours on days -7 and -6, fludarabine phosphate IV daily over 15-30 minutes on days -5 to -1, and CXCR2-transduced autologous TIL and NGFR-transduced autologous TIL IV over up to 4 hours on day 0. Participants then receive high-dose aldesleukin IV over 15 minutes every 8-16 hours on days 1-5 (up to 15 doses) and 22-26 (up to 15 doses).
Aldesleukin: Given IV
CXCR2-transduced Autologous Tumor Infiltrating Lymphocytes: Given IV
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
NGFR-transduced Autologous T Lymphocytes: Given IV
Quality-of-Life Assessment: Ancillary studies
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Treatment (Genetically Modified T-cells, High-dose Aldesleukin
Participants receive cyclophosphamide IV over 2 hours on days -7 and -6, fludarabine phosphate IV daily over 15-30 minutes on days -5 to -1, and CXCR2-transduced autologous TIL and NGFR-transduced autologous TIL IV over up to 4 hours on day 0. Participants then receive high-dose aldesleukin IV over 15 minutes every 8-16 hours on days 1-5 (up to 15 doses) and 22-26 (up to 15 doses).
Aldesleukin: Given IV
CXCR2-transduced Autologous Tumor Infiltrating Lymphocytes: Given IV
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
NGFR-transduced Autologous T Lymphocytes: Given IV
Quality-of-Life Assessment: Ancillary studies
|
|---|---|
|
Overall Study
Ineligible
|
1
|
|
Overall Study
Screen failure
|
1
|
Baseline Characteristics
Genetically Modified Therapeutic Autologous Lymphocytes Followed by Aldesleukin in Treating Patients With Stage III or Metastatic Melanoma
Baseline characteristics by cohort
| Measure |
Treatment (Genetically Modified T-cells, High-dose Aldesleukin
n=8 Participants
Participants receive cyclophosphamide IV over 2 hours on days -7 and -6, fludarabine phosphate IV daily over 15-30 minutes on days -5 to -1, and CXCR2-transduced autologous TIL and NGFR-transduced autologous TIL IV over up to 4 hours on day 0. Participants then receive high-dose aldesleukin IV over 15 minutes every 8-16 hours on days 1-5 (up to 15 doses) and 22-26 (up to 15 doses).
Aldesleukin: Given IV
CXCR2-transduced Autologous Tumor Infiltrating Lymphocytes: Given IV
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
NGFR-transduced Autologous T Lymphocytes: Given IV
Quality-of-Life Assessment: Ancillary studies
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 1 yearResponse will be defined as a 50% or greater decrease in the tumor's linear dimension post treatment, compared to baseline. Response will be evaluated by positron emission tomography or computed tomography imaging.
Outcome measures
| Measure |
Treatment (Genetically Modified T-cells, High-dose Aldesleukin
n=8 Participants
Participants receive cyclophosphamide IV over 2 hours on days -7 and -6, fludarabine phosphate IV daily over 15-30 minutes on days -5 to -1, and CXCR2-transduced autologous TIL and NGFR-transduced autologous TIL IV over up to 4 hours on day 0. Participants then receive high-dose aldesleukin IV over 15 minutes every 8-16 hours on days 1-5 (up to 15 doses) and 22-26 (up to 15 doses).
Aldesleukin: Given IV
CXCR2-transduced Autologous Tumor Infiltrating Lymphocytes: Given IV
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
NGFR-transduced Autologous T Lymphocytes: Given IV
Quality-of-Life Assessment: Ancillary studies
|
|---|---|
|
Number of Participants With Immune-Related Response
|
8 Participants
|
PRIMARY outcome
Timeframe: Up to 8 weeksPossible grade 3 or worse toxicities not normally associated with lymphodepletion and high dose IL-2 will be reported.
Outcome measures
| Measure |
Treatment (Genetically Modified T-cells, High-dose Aldesleukin
n=8 Participants
Participants receive cyclophosphamide IV over 2 hours on days -7 and -6, fludarabine phosphate IV daily over 15-30 minutes on days -5 to -1, and CXCR2-transduced autologous TIL and NGFR-transduced autologous TIL IV over up to 4 hours on day 0. Participants then receive high-dose aldesleukin IV over 15 minutes every 8-16 hours on days 1-5 (up to 15 doses) and 22-26 (up to 15 doses).
Aldesleukin: Given IV
CXCR2-transduced Autologous Tumor Infiltrating Lymphocytes: Given IV
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
NGFR-transduced Autologous T Lymphocytes: Given IV
Quality-of-Life Assessment: Ancillary studies
|
|---|---|
|
Number of Participants With Adverse Events Defined as Possible Grade 3 or Worse Toxicities
|
8 Participants
|
SECONDARY outcome
Timeframe: At infusionPopulation: Data were not collected
Determine whether CXCR2 transduction enhances the ability of TIL to migrate to melanoma tumors. his is a statistical version of the intuitive idea that, if the TIL methodology works as designed and the genetically transduced T-cells differentially recognize the cancer cell cytokines, then the ratio of post- and pre-treatment ratios RR = RY/RX should be larger than 1.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At infusionPopulation: Data were not collected
Determine the levels of CXCL1 and CXCL8 chemokines produced by melanoma tumors and assess whether this correlates with the tumor localization of CXCR2 transduced TIL
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At infusionPopulation: Data were not collected
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Genetically Modified T-cells, High-dose Aldesleukin
Serious events: 8 serious events
Other events: 8 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Treatment (Genetically Modified T-cells, High-dose Aldesleukin
n=8 participants at risk
Participants receive cyclophosphamide IV over 2 hours on days -7 and -6, fludarabine phosphate IV daily over 15-30 minutes on days -5 to -1, and CXCR2-transduced autologous TIL and NGFR-transduced autologous TIL IV over up to 4 hours on day 0. Participants then receive high-dose aldesleukin IV over 15 minutes every 8-16 hours on days 1-5 (up to 15 doses) and 22-26 (up to 15 doses).
Aldesleukin: Given IV
CXCR2-transduced Autologous Tumor Infiltrating Lymphocytes: Given IV
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
NGFR-transduced Autologous T Lymphocytes: Given IV
Quality-of-Life Assessment: Ancillary studies
|
|---|---|
|
General disorders
Death
|
12.5%
1/8 • Number of events 1 • From Baseline to 1 year follow-up
|
|
Nervous system disorders
Seizure
|
12.5%
1/8 • Number of events 2 • From Baseline to 1 year follow-up
|
|
General disorders
Fever
|
50.0%
4/8 • Number of events 6 • From Baseline to 1 year follow-up
|
|
Infections and infestations
Lung Infection
|
25.0%
2/8 • Number of events 3 • From Baseline to 1 year follow-up
|
Other adverse events
| Measure |
Treatment (Genetically Modified T-cells, High-dose Aldesleukin
n=8 participants at risk
Participants receive cyclophosphamide IV over 2 hours on days -7 and -6, fludarabine phosphate IV daily over 15-30 minutes on days -5 to -1, and CXCR2-transduced autologous TIL and NGFR-transduced autologous TIL IV over up to 4 hours on day 0. Participants then receive high-dose aldesleukin IV over 15 minutes every 8-16 hours on days 1-5 (up to 15 doses) and 22-26 (up to 15 doses).
Aldesleukin: Given IV
CXCR2-transduced Autologous Tumor Infiltrating Lymphocytes: Given IV
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
NGFR-transduced Autologous T Lymphocytes: Given IV
Quality-of-Life Assessment: Ancillary studies
|
|---|---|
|
Gastrointestinal disorders
Abdominal Distension
|
12.5%
1/8 • Number of events 2 • From Baseline to 1 year follow-up
|
|
Investigations
Activated partial thromboplastin time prolonged
|
87.5%
7/8 • Number of events 21 • From Baseline to 1 year follow-up
|
|
Investigations
Alanine aminotransferase increased
|
25.0%
2/8 • Number of events 12 • From Baseline to 1 year follow-up
|
|
Investigations
Alkaline phosphatase increased
|
62.5%
5/8 • Number of events 7 • From Baseline to 1 year follow-up
|
|
Immune system disorders
Allergic Reaction
|
12.5%
1/8 • Number of events 1 • From Baseline to 1 year follow-up
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
100.0%
8/8 • Number of events 9 • From Baseline to 1 year follow-up
|
|
Blood and lymphatic system disorders
Anemia
|
87.5%
7/8 • Number of events 67 • From Baseline to 1 year follow-up
|
|
Metabolism and nutrition disorders
Anorexia
|
87.5%
7/8 • Number of events 16 • From Baseline to 1 year follow-up
|
|
Psychiatric disorders
Anxiety
|
50.0%
4/8 • Number of events 5 • From Baseline to 1 year follow-up
|
|
Investigations
Aspartate aminotransferase increased
|
75.0%
6/8 • Number of events 12 • From Baseline to 1 year follow-up
|
|
Blood and lymphatic system disorders
Absolute monocyte count decreased
|
12.5%
1/8 • Number of events 1 • From Baseline to 1 year follow-up
|
|
Blood and lymphatic system disorders
Absolute basophil cound decreased
|
12.5%
1/8 • Number of events 1 • From Baseline to 1 year follow-up
|
|
Musculoskeletal and connective tissue disorders
Back Pain (right side lower back)
|
12.5%
1/8 • Number of events 2 • From Baseline to 1 year follow-up
|
|
Gastrointestinal disorders
Bloating
|
12.5%
1/8 • Number of events 1 • From Baseline to 1 year follow-up
|
|
Investigations
Bibasilar
|
12.5%
1/8 • Number of events 1 • From Baseline to 1 year follow-up
|
|
Blood and lymphatic system disorders
Blood bilirubin increased
|
100.0%
8/8 • Number of events 10 • From Baseline to 1 year follow-up
|
|
General disorders
Chills
|
100.0%
8/8 • Number of events 20 • From Baseline to 1 year follow-up
|
|
Gastrointestinal disorders
Constipation
|
62.5%
5/8 • Number of events 9 • From Baseline to 1 year follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
4/8 • Number of events 5 • From Baseline to 1 year follow-up
|
|
Investigations
Creatinine increased
|
62.5%
5/8 • Number of events 18 • From Baseline to 1 year follow-up
|
|
Gastrointestinal disorders
Diarrhea
|
62.5%
5/8 • Number of events 9 • From Baseline to 1 year follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Diminished lung sounds- right
|
12.5%
1/8 • Number of events 2 • From Baseline to 1 year follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Diminished lung sounds- left
|
25.0%
2/8 • Number of events 4 • From Baseline to 1 year follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Diminished lung sound bilateral
|
12.5%
1/8 • Number of events 1 • From Baseline to 1 year follow-up
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
50.0%
4/8 • Number of events 6 • From Baseline to 1 year follow-up
|
|
Skin and subcutaneous tissue disorders
Dermititis
|
25.0%
2/8 • Number of events 2 • From Baseline to 1 year follow-up
|
|
Skin and subcutaneous tissue disorders
Dark discoloration
|
12.5%
1/8 • Number of events 1 • From Baseline to 1 year follow-up
|
|
Nervous system disorders
Dizziness
|
37.5%
3/8 • Number of events 3 • From Baseline to 1 year follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
62.5%
5/8 • Number of events 8 • From Baseline to 1 year follow-up
|
|
Renal and urinary disorders
Dysuria
|
12.5%
1/8 • Number of events 1 • From Baseline to 1 year follow-up
|
|
General disorders
Edema Limbs
|
50.0%
4/8 • Number of events 10 • From Baseline to 1 year follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
12.5%
1/8 • Number of events 1 • From Baseline to 1 year follow-up
|
|
Investigations
CK increased
|
12.5%
1/8 • Number of events 1 • From Baseline to 1 year follow-up
|
|
Investigations
Decreased protein
|
12.5%
1/8 • Number of events 1 • From Baseline to 1 year follow-up
|
|
Eye disorders
Dry eye
|
12.5%
1/8 • Number of events 1 • From Baseline to 1 year follow-up
|
|
Nervous system disorders
Dysgeusia
|
12.5%
1/8 • Number of events 1 • From Baseline to 1 year follow-up
|
|
General disorders
Edema (face)
|
12.5%
1/8 • Number of events 2 • From Baseline to 1 year follow-up
|
|
General disorders
Edema (trunk)
|
12.5%
1/8 • Number of events 1 • From Baseline to 1 year follow-up
|
|
Cardiac disorders
ECG QT
|
12.5%
1/8 • Number of events 1 • From Baseline to 1 year follow-up
|
|
Investigations
Elevated LDH
|
12.5%
1/8 • Number of events 1 • From Baseline to 1 year follow-up
|
|
Gastrointestinal disorders
Esophagitis
|
12.5%
1/8 • Number of events 1 • From Baseline to 1 year follow-up
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
12.5%
1/8 • Number of events 1 • From Baseline to 1 year follow-up
|
|
Gastrointestinal disorders
Gastitis
|
12.5%
1/8 • Number of events 1 • From Baseline to 1 year follow-up
|
|
Infections and infestations
Tinea Cruris (fungal goin infection)
|
12.5%
1/8 • Number of events 1 • From Baseline to 1 year follow-up
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
25.0%
2/8 • Number of events 2 • From Baseline to 1 year follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Lung cracles- right
|
12.5%
1/8 • Number of events 1 • From Baseline to 1 year follow-up
|
|
Skin and subcutaneous tissue disorders
Erythema
|
25.0%
2/8 • Number of events 2 • From Baseline to 1 year follow-up
|
|
Skin and subcutaneous tissue disorders
Erythematous Rash
|
12.5%
1/8 • Number of events 1 • From Baseline to 1 year follow-up
|
|
Blood and lymphatic system disorders
Fatigue
|
87.5%
7/8 • Number of events 14 • From Baseline to 1 year follow-up
|
|
General disorders
Fever
|
50.0%
4/8 • Number of events 6 • From Baseline to 1 year follow-up
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
50.0%
4/8 • Number of events 7 • From Baseline to 1 year follow-up
|
|
Gastrointestinal disorders
Floaters
|
12.5%
1/8 • Number of events 1 • From Baseline to 1 year follow-up
|
|
Gastrointestinal disorders
Generalised edema
|
12.5%
1/8 • Number of events 1 • From Baseline to 1 year follow-up
|
|
General disorders
Generalized erythema
|
12.5%
1/8 • Number of events 1 • From Baseline to 1 year follow-up
|
|
General disorders
Generalized muscle weakness
|
50.0%
4/8 • Number of events 6 • From Baseline to 1 year follow-up
|
|
Nervous system disorders
Headache
|
37.5%
3/8 • Number of events 4 • From Baseline to 1 year follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
12.5%
1/8 • Number of events 1 • From Baseline to 1 year follow-up
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
62.5%
5/8 • Number of events 16 • From Baseline to 1 year follow-up
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
50.0%
4/8 • Number of events 9 • From Baseline to 1 year follow-up
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
25.0%
2/8 • Number of events 2 • From Baseline to 1 year follow-up
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
12.5%
1/8 • Number of events 2 • From Baseline to 1 year follow-up
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
75.0%
6/8 • Number of events 26 • From Baseline to 1 year follow-up
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
62.5%
5/8 • Number of events 16 • From Baseline to 1 year follow-up
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
12.5%
1/8 • Number of events 1 • From Baseline to 1 year follow-up
|
|
Metabolism and nutrition disorders
Hypokalemia
|
25.0%
2/8 • Number of events 2 • From Baseline to 1 year follow-up
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
62.5%
5/8 • Number of events 11 • From Baseline to 1 year follow-up
|
|
Metabolism and nutrition disorders
Hyponatremia
|
50.0%
4/8 • Number of events 12 • From Baseline to 1 year follow-up
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
12.5%
1/8 • Number of events 1 • From Baseline to 1 year follow-up
|
|
Vascular disorders
Hypotension
|
50.0%
4/8 • Number of events 6 • From Baseline to 1 year follow-up
|
|
Endocrine disorders
Hypothyrodism
|
12.5%
1/8 • Number of events 1 • From Baseline to 1 year follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
12.5%
1/8 • Number of events 1 • From Baseline to 1 year follow-up
|
|
Investigations
INR Increased
|
75.0%
6/8 • Number of events 11 • From Baseline to 1 year follow-up
|
|
Psychiatric disorders
Insomnia
|
37.5%
3/8 • Number of events 3 • From Baseline to 1 year follow-up
|
|
General disorders
LDH Increased
|
12.5%
1/8 • Number of events 4 • From Baseline to 1 year follow-up
|
|
Vascular disorders
Lymphedema
|
25.0%
2/8 • Number of events 2 • From Baseline to 1 year follow-up
|
|
Investigations
Localized edema
|
12.5%
1/8 • Number of events 1 • From Baseline to 1 year follow-up
|
|
Investigations
Ionized Calcium
|
12.5%
1/8 • Number of events 1 • From Baseline to 1 year follow-up
|
|
Investigations
Lymphocyte count decreased
|
62.5%
5/8 • Number of events 17 • From Baseline to 1 year follow-up
|
|
Blood and lymphatic system disorders
Ionized Calcium
|
12.5%
1/8 • Number of events 1 • From Baseline to 1 year follow-up
|
|
Reproductive system and breast disorders
Menorrhagia
|
12.5%
1/8 • Number of events 1 • From Baseline to 1 year follow-up
|
|
Gastrointestinal disorders
Mucosal Infection
|
12.5%
1/8 • Number of events 1 • From Baseline to 1 year follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
12.5%
1/8 • Number of events 1 • From Baseline to 1 year follow-up
|
|
Gastrointestinal disorders
Nausea
|
75.0%
6/8 • Number of events 9 • From Baseline to 1 year follow-up
|
|
Blood and lymphatic system disorders
Alkaline phosphate decreased
|
12.5%
1/8 • Number of events 7 • From Baseline to 1 year follow-up
|
|
Investigations
Oliguria
|
12.5%
1/8 • Number of events 1 • From Baseline to 1 year follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Lung Infection (pneumonia)
|
25.0%
2/8 • Number of events 3 • From Baseline to 1 year follow-up
|
|
Investigations
Neutrophil count decreased
|
100.0%
8/8 • Number of events 25 • From Baseline to 1 year follow-up
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
12.5%
1/8 • Number of events 1 • From Baseline to 1 year follow-up
|
|
General disorders
Pain
|
50.0%
4/8 • Number of events 5 • From Baseline to 1 year follow-up
|
|
Cardiac disorders
Palpitations
|
12.5%
1/8 • Number of events 1 • From Baseline to 1 year follow-up
|
|
Investigations
Phosphorus increased
|
25.0%
2/8 • Number of events 2 • From Baseline to 1 year follow-up
|
|
Investigations
Platelet count decreased
|
100.0%
8/8 • Number of events 54 • From Baseline to 1 year follow-up
|
|
Investigations
Platelet count increased
|
12.5%
1/8 • Number of events 1 • From Baseline to 1 year follow-up
|
|
Investigations
Protein decreased
|
12.5%
1/8 • Number of events 1 • From Baseline to 1 year follow-up
|
|
Skin and subcutaneous tissue disorders
Petechia
|
25.0%
2/8 • Number of events 4 • From Baseline to 1 year follow-up
|
|
Cardiac disorders
Palpations
|
12.5%
1/8 • Number of events 1 • From Baseline to 1 year follow-up
|
|
Nervous system disorders
Paresthesia (left shoulder)
|
12.5%
1/8 • Number of events 1 • From Baseline to 1 year follow-up
|
|
Nervous system disorders
Peripheral sensory neuropathy (bilateral hands/feet)
|
25.0%
2/8 • Number of events 2 • From Baseline to 1 year follow-up
|
|
Skin and subcutaneous tissue disorders
Purpura
|
12.5%
1/8 • Number of events 2 • From Baseline to 1 year follow-up
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
12.5%
1/8 • Number of events 1 • From Baseline to 1 year follow-up
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
75.0%
6/8 • Number of events 6 • From Baseline to 1 year follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
12.5%
1/8 • Number of events 1 • From Baseline to 1 year follow-up
|
|
Skin and subcutaneous tissue disorders
Rash masculo-papular
|
37.5%
3/8 • Number of events 9 • From Baseline to 1 year follow-up
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
12.5%
1/8 • Number of events 1 • From Baseline to 1 year follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory acidosis
|
12.5%
1/8 • Number of events 3 • From Baseline to 1 year follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
12.5%
1/8 • Number of events 1 • From Baseline to 1 year follow-up
|
|
Cardiac disorders
Sinus tachycardia
|
62.5%
5/8 • Number of events 9 • From Baseline to 1 year follow-up
|
|
Nervous system disorders
Seizure
|
12.5%
1/8 • Number of events 2 • From Baseline to 1 year follow-up
|
|
Skin and subcutaneous tissue disorders
Seborrheic keratosis
|
12.5%
1/8 • Number of events 1 • From Baseline to 1 year follow-up
|
|
Skin and subcutaneous tissue disorders
Skin Hyperpigmentation
|
12.5%
1/8 • Number of events 1 • From Baseline to 1 year follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Sleep Apnea
|
12.5%
1/8 • Number of events 1 • From Baseline to 1 year follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
25.0%
2/8 • Number of events 3 • From Baseline to 1 year follow-up
|
|
Cardiac disorders
Superventricular tachycardis
|
12.5%
1/8 • Number of events 1 • From Baseline to 1 year follow-up
|
|
Cardiac disorders
Tachycardia
|
12.5%
1/8 • Number of events 1 • From Baseline to 1 year follow-up
|
|
Psychiatric disorders
Sommolence
|
12.5%
1/8 • Number of events 1 • From Baseline to 1 year follow-up
|
|
Gastrointestinal disorders
Thrush
|
12.5%
1/8 • Number of events 1 • From Baseline to 1 year follow-up
|
|
Metabolism and nutrition disorders
Total protein decreased
|
25.0%
2/8 • Number of events 3 • From Baseline to 1 year follow-up
|
|
Investigations
TSH increased
|
25.0%
2/8 • Number of events 3 • From Baseline to 1 year follow-up
|
|
Blood and lymphatic system disorders
Uric acid decreased
|
12.5%
1/8 • Number of events 2 • From Baseline to 1 year follow-up
|
|
Renal and urinary disorders
Urinary frequency
|
25.0%
2/8 • Number of events 2 • From Baseline to 1 year follow-up
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
12.5%
1/8 • Number of events 1 • From Baseline to 1 year follow-up
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
4/8 • Number of events 4 • From Baseline to 1 year follow-up
|
|
Investigations
Weight gain
|
50.0%
4/8 • Number of events 13 • From Baseline to 1 year follow-up
|
|
Investigations
Weight loss
|
50.0%
4/8 • Number of events 4 • From Baseline to 1 year follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
12.5%
1/8 • Number of events 2 • From Baseline to 1 year follow-up
|
|
Investigations
White blood cell decreased
|
50.0%
4/8 • Number of events 11 • From Baseline to 1 year follow-up
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place