Trial Outcomes & Findings for Evaluation of Circulating T Cells and Tumor Infiltrating Lymphocytes (TILs) During / After Pre-Surgery Chemotherapy in Non-Small Cell Lung Cancer (NSCLC) (NCT NCT01820754)
NCT ID: NCT01820754
Last Updated: 2021-02-26
Results Overview
The primary objective of this trial is to determine the percentage of early stage lung cancer patients with detectable circulating T cells specific against tumor-associated antigen (TAA) after receiving platinum based neoadjuvant chemotherapy plus ipilimumab before surgery. Based on Duke intracellular cytokine staining (ICS) assessments over the past 8 years, "detectable" circulating T cells with specificity against TAA are defined as a CD8, CD4, and double positive (DP) (CD4+CD8+) lymphocyte percentage of ≥ 0.05% with each value also being at least twice that of the background unstimulated control value.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
3 months
Results posted on
2021-02-26
Participant Flow
Participant milestones
| Measure |
Ipilimumab
Neoadjuvant: Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes Adjuvant: Ipilimumab 10 mg/kg IV every 3 weeks times 2 doses beginning 4 weeks postoperative ( up to 10 weeks if needed for recovery) Maintenance: Ipilimumab 10 mg/kg/IV every 12 weeks times 2 doses
Ipilimumab: Neoadjuvant: Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes
Adjuvant (Post-Surgery): Ipilimumab 10 mg/kg IV every 3 weeks times 2 doses beginning 4 weeks postoperative ( up to 10 weeks if needed for recovery)
Maintenance: Ipilimumab 10 mg/kg/IV every 12 weeks times 2 doses
Paclitaxel, Cisplatin, Carboplatin: Neoadjuvant (Pre-Surgery) Cycle 1: Paclitaxel 175 mg/m2 IV over 3 hours , followed by Cisplatin 75 mg/m2 IV over 60 minutes or carboplatin Area Under Curve (AUC) 6 IV over 30-60 minutes on day 1(Every 21 days x 1 cycle)
Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes, Paclitaxel 175 mg/m2 IV over 3 hours , followed by Cisplatin
|
|---|---|
|
Overall Study
STARTED
|
24
|
|
Overall Study
COMPLETED
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Circulating T Cells and Tumor Infiltrating Lymphocytes (TILs) During / After Pre-Surgery Chemotherapy in Non-Small Cell Lung Cancer (NSCLC)
Baseline characteristics by cohort
| Measure |
Ipilimumab
n=24 Participants
Neoadjuvant: Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes Adjuvant: Ipilimumab 10 mg/kg IV every 3 weeks times 2 doses beginning 4 weeks postoperative ( up to 10 weeks if needed for recovery) Maintenance: Ipilimumab 10 mg/kg/IV every 12 weeks times 2 doses
Ipilimumab: Neoadjuvant: Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes
Adjuvant (Post-Surgery): Ipilimumab 10 mg/kg IV every 3 weeks times 2 doses beginning 4 weeks postoperative ( up to 10 weeks if needed for recovery)
Maintenance: Ipilimumab 10 mg/kg/IV every 12 weeks times 2 doses
Paclitaxel, Cisplatin, Carboplatin: Neoadjuvant (Pre-Surgery) Cycle 1: Paclitaxel 175 mg/m2 IV over 3 hours , followed by Cisplatin 75 mg/m2 IV over 60 minutes or carboplatin AUC 6 IV over 30-60 minutes on day 1(Every 21 days x 1 cycle)
Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes, Paclitaxel 175 mg/m2 IV over 3 hours , followed by Cisplatin
|
|---|---|
|
Age, Continuous
|
65.3 Years
STANDARD_DEVIATION 8.0 • n=99 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Intent to treat. Note that the 16.7% of patients that had detectable T-cell responses also had responses at baseline
The primary objective of this trial is to determine the percentage of early stage lung cancer patients with detectable circulating T cells specific against tumor-associated antigen (TAA) after receiving platinum based neoadjuvant chemotherapy plus ipilimumab before surgery. Based on Duke intracellular cytokine staining (ICS) assessments over the past 8 years, "detectable" circulating T cells with specificity against TAA are defined as a CD8, CD4, and double positive (DP) (CD4+CD8+) lymphocyte percentage of ≥ 0.05% with each value also being at least twice that of the background unstimulated control value.
Outcome measures
| Measure |
Ipilimumab
n=24 Participants
Neoadjuvant: Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes Adjuvant: Ipilimumab 10 mg/kg IV every 3 weeks times 2 doses beginning 4 weeks postoperative ( up to 10 weeks if needed for recovery) Maintenance: Ipilimumab 10 mg/kg/IV every 12 weeks times 2 doses
Ipilimumab: Neoadjuvant: Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes
Adjuvant (Post-Surgery): Ipilimumab 10 mg/kg IV every 3 weeks times 2 doses beginning 4 weeks postoperative ( up to 10 weeks if needed for recovery)
Maintenance: Ipilimumab 10 mg/kg/IV every 12 weeks times 2 doses
Paclitaxel, Cisplatin, Carboplatin: Neoadjuvant (Pre-Surgery) Cycle 1: Paclitaxel 175 mg/m2 IV over 3 hours , followed by Cisplatin 75 mg/m2 IV over 60 minutes or carboplatin AUC 6 IV over 30-60 minutes on day 1(Every 21 days x 1 cycle)
Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes, Paclitaxel 175 mg/m2 IV over 3 hours , followed by Cisplatin
|
|---|---|
|
Percentage of Subjects With Detectable Circulating T Cells After Treatment
|
16.7 Percentage of participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Intent to treat
Number of subjects experiencing any of the criteria listed below: * Number of subjects receiving 3 doses of preoperative therapy * Number of subjects undergoing surgical exploration within 42 days of day 1 of the last cycle of neoadjuvant chemotherapy * Number of subjects undergoing lobectomy having surgery-related mortality * Number of subjects experiencing dose-limiting toxicity (DLT) during neoadjuvant therapy. DLT will be defined as treatment-related: ≥ Grade 4 hematologic toxicity (excluding neutropenia without fever or infection) or ≥ Grade 3 non-hematologic toxicity (excluding fatigue, nausea, vomiting, peripheral neuropathy, chemotherapy infusion reaction to carboplatin or paclitaxel)
Outcome measures
| Measure |
Ipilimumab
n=24 Participants
Neoadjuvant: Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes Adjuvant: Ipilimumab 10 mg/kg IV every 3 weeks times 2 doses beginning 4 weeks postoperative ( up to 10 weeks if needed for recovery) Maintenance: Ipilimumab 10 mg/kg/IV every 12 weeks times 2 doses
Ipilimumab: Neoadjuvant: Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes
Adjuvant (Post-Surgery): Ipilimumab 10 mg/kg IV every 3 weeks times 2 doses beginning 4 weeks postoperative ( up to 10 weeks if needed for recovery)
Maintenance: Ipilimumab 10 mg/kg/IV every 12 weeks times 2 doses
Paclitaxel, Cisplatin, Carboplatin: Neoadjuvant (Pre-Surgery) Cycle 1: Paclitaxel 175 mg/m2 IV over 3 hours , followed by Cisplatin 75 mg/m2 IV over 60 minutes or carboplatin AUC 6 IV over 30-60 minutes on day 1(Every 21 days x 1 cycle)
Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes, Paclitaxel 175 mg/m2 IV over 3 hours , followed by Cisplatin
|
|---|---|
|
Feasibility and Tolerability of Neoadjuvant Chemotherapy Plus Ipilimumab and Surgery
Patients receiving 3 cycles
|
24 Participants
|
|
Feasibility and Tolerability of Neoadjuvant Chemotherapy Plus Ipilimumab and Surgery
Patients undergoing surgical exploration
|
13 Participants
|
|
Feasibility and Tolerability of Neoadjuvant Chemotherapy Plus Ipilimumab and Surgery
Patients undergoing lobectomy
|
11 Participants
|
|
Feasibility and Tolerability of Neoadjuvant Chemotherapy Plus Ipilimumab and Surgery
Patients experiencing a DLT
|
3 Participants
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: Patients were no longer followed for recurrence following surgery, so this outcome was not captured
Disease-free survival (DFS) is defined as the time from surgical resection to disease recurrence (first disease recurrence or death, whichever comes first) after surgery. Patients alive who had not recurred as of the last follow-up had DFS censored at the last follow-up date. The Kaplan-Meier estimator will be used to estimate median DFS and its 95% confidence interval.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 monthsPopulation: Intent to treat
Number of patients experiencing a metastasis between baseline and cycle 3
Outcome measures
| Measure |
Ipilimumab
n=24 Participants
Neoadjuvant: Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes Adjuvant: Ipilimumab 10 mg/kg IV every 3 weeks times 2 doses beginning 4 weeks postoperative ( up to 10 weeks if needed for recovery) Maintenance: Ipilimumab 10 mg/kg/IV every 12 weeks times 2 doses
Ipilimumab: Neoadjuvant: Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes
Adjuvant (Post-Surgery): Ipilimumab 10 mg/kg IV every 3 weeks times 2 doses beginning 4 weeks postoperative ( up to 10 weeks if needed for recovery)
Maintenance: Ipilimumab 10 mg/kg/IV every 12 weeks times 2 doses
Paclitaxel, Cisplatin, Carboplatin: Neoadjuvant (Pre-Surgery) Cycle 1: Paclitaxel 175 mg/m2 IV over 3 hours , followed by Cisplatin 75 mg/m2 IV over 60 minutes or carboplatin AUC 6 IV over 30-60 minutes on day 1(Every 21 days x 1 cycle)
Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes, Paclitaxel 175 mg/m2 IV over 3 hours , followed by Cisplatin
|
|---|---|
|
Number of Subjects Experiencing a Metastasis by Site of Metastasis
|
1 Participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Note: pathological response was not captured for study participants. Therefore, the RECIST responses for patients at neoadjuvant month 3 are reported.
Within each category of RECIST response \[partial response (PR), stable disease (SD), progressive disease (PD)\], the number of subjects experiencing a pathologic complete response, pathologic partial response, and no pathologic response. RECIST evaluation will be conducted after completion of neoadjuvant therapy. Pathologic response will be evaluated in the resected tumor as follows: * No Pathologic Response: No evidence of cell death or tumor necrosis * Pathologic Partial Response: ≥30% tumor necrosis or cell death * Pathologic Complete Response: No evidence of viable tumor in surgical specimen (includes lung tissue and dissected lymph nodes)
Outcome measures
| Measure |
Ipilimumab
n=24 Participants
Neoadjuvant: Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes Adjuvant: Ipilimumab 10 mg/kg IV every 3 weeks times 2 doses beginning 4 weeks postoperative ( up to 10 weeks if needed for recovery) Maintenance: Ipilimumab 10 mg/kg/IV every 12 weeks times 2 doses
Ipilimumab: Neoadjuvant: Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes
Adjuvant (Post-Surgery): Ipilimumab 10 mg/kg IV every 3 weeks times 2 doses beginning 4 weeks postoperative ( up to 10 weeks if needed for recovery)
Maintenance: Ipilimumab 10 mg/kg/IV every 12 weeks times 2 doses
Paclitaxel, Cisplatin, Carboplatin: Neoadjuvant (Pre-Surgery) Cycle 1: Paclitaxel 175 mg/m2 IV over 3 hours , followed by Cisplatin 75 mg/m2 IV over 60 minutes or carboplatin AUC 6 IV over 30-60 minutes on day 1(Every 21 days x 1 cycle)
Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes, Paclitaxel 175 mg/m2 IV over 3 hours , followed by Cisplatin
|
|---|---|
|
Patterns of Pathologic Response and Response Evaluation Criteria in Solid Tumor (RECIST) Response
PR
|
14 Participants
|
|
Patterns of Pathologic Response and Response Evaluation Criteria in Solid Tumor (RECIST) Response
SD
|
8 Participants
|
|
Patterns of Pathologic Response and Response Evaluation Criteria in Solid Tumor (RECIST) Response
PD
|
2 Participants
|
Adverse Events
Ipilimumab
Serious events: 6 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ipilimumab
n=24 participants at risk
Neoadjuvant: Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes Adjuvant: Ipilimumab 10 mg/kg IV every 3 weeks times 2 doses beginning 4 weeks postoperative ( up to 10 weeks if needed for recovery) Maintenance: Ipilimumab 10 mg/kg/IV every 12 weeks times 2 doses
Ipilimumab: Neoadjuvant: Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes
Adjuvant (Post-Surgery): Ipilimumab 10 mg/kg IV every 3 weeks times 2 doses beginning 4 weeks postoperative ( up to 10 weeks if needed for recovery)
Maintenance: Ipilimumab 10 mg/kg/IV every 12 weeks times 2 doses
Paclitaxel, Cisplatin, Carboplatin: Neoadjuvant (Pre-Surgery) Cycle 1: Paclitaxel 175 mg/m2 IV over 3 hours , followed by Cisplatin 75 mg/m2 IV over 60 minutes or carboplatin AUC 6 IV over 30-60 minutes on day 1(Every 21 days x 1 cycle)
Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes, Paclitaxel 175 mg/m2 IV over 3 hours , followed by Cisplatin
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
4.2%
1/24 • 6 months
|
|
Gastrointestinal disorders
Diarrhea
|
4.2%
1/24 • 6 months
|
|
Gastrointestinal disorders
Dysphagia
|
4.2%
1/24 • 6 months
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
4.2%
1/24 • 6 months
|
|
Infections and infestations
Lung infection
|
4.2%
1/24 • 6 months
|
|
Investigations
Neutrophil count decreased
|
4.2%
1/24 • 6 months
|
|
Metabolism and nutrition disorders
Dehydration
|
8.3%
2/24 • 6 months
|
|
Renal and urinary disorders
Acute kidney injury
|
4.2%
1/24 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.2%
1/24 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal hemorrhage
|
4.2%
1/24 • 6 months
|
|
Vascular disorders
Thromboembolic event
|
8.3%
2/24 • 6 months
|
Other adverse events
| Measure |
Ipilimumab
n=24 participants at risk
Neoadjuvant: Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes Adjuvant: Ipilimumab 10 mg/kg IV every 3 weeks times 2 doses beginning 4 weeks postoperative ( up to 10 weeks if needed for recovery) Maintenance: Ipilimumab 10 mg/kg/IV every 12 weeks times 2 doses
Ipilimumab: Neoadjuvant: Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes
Adjuvant (Post-Surgery): Ipilimumab 10 mg/kg IV every 3 weeks times 2 doses beginning 4 weeks postoperative ( up to 10 weeks if needed for recovery)
Maintenance: Ipilimumab 10 mg/kg/IV every 12 weeks times 2 doses
Paclitaxel, Cisplatin, Carboplatin: Neoadjuvant (Pre-Surgery) Cycle 1: Paclitaxel 175 mg/m2 IV over 3 hours , followed by Cisplatin 75 mg/m2 IV over 60 minutes or carboplatin AUC 6 IV over 30-60 minutes on day 1(Every 21 days x 1 cycle)
Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes, Paclitaxel 175 mg/m2 IV over 3 hours , followed by Cisplatin
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
87.5%
21/24 • 6 months
|
|
Cardiac disorders
Atrial fibrillation
|
8.3%
2/24 • 6 months
|
|
Cardiac disorders
Cardiac disorders - Other, specify: PACS, PATS
|
4.2%
1/24 • 6 months
|
|
Cardiac disorders
Chest pain - cardiac
|
8.3%
2/24 • 6 months
|
|
Cardiac disorders
Palpitations
|
4.2%
1/24 • 6 months
|
|
Cardiac disorders
Sinus tachycardia
|
8.3%
2/24 • 6 months
|
|
Cardiac disorders
Supraventricular tachycardia
|
4.2%
1/24 • 6 months
|
|
Ear and labyrinth disorders
Ear pain
|
4.2%
1/24 • 6 months
|
|
Endocrine disorders
Adrenal insufficiency
|
16.7%
4/24 • 6 months
|
|
Endocrine disorders
Endocrine disorders - Other, specify: NIGHT SWEATS
|
4.2%
1/24 • 6 months
|
|
Eye disorders
Eye disorders - Other, specify: AURA WHEN READING THIS MORNING
|
4.2%
1/24 • 6 months
|
|
Gastrointestinal disorders
Abdominal pain
|
12.5%
3/24 • 6 months
|
|
Gastrointestinal disorders
Cheilitis
|
4.2%
1/24 • 6 months
|
|
Gastrointestinal disorders
Colitis
|
12.5%
3/24 • 6 months
|
|
Gastrointestinal disorders
Constipation
|
33.3%
8/24 • 6 months
|
|
Gastrointestinal disorders
Diarrhea
|
37.5%
9/24 • 6 months
|
|
Gastrointestinal disorders
Dry mouth
|
4.2%
1/24 • 6 months
|
|
Gastrointestinal disorders
Dyspepsia
|
8.3%
2/24 • 6 months
|
|
Gastrointestinal disorders
Dysphagia
|
8.3%
2/24 • 6 months
|
|
Gastrointestinal disorders
Gastritis
|
12.5%
3/24 • 6 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
8.3%
2/24 • 6 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify: GAS
|
4.2%
1/24 • 6 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify: GASSY, BURPING
|
4.2%
1/24 • 6 months
|
|
Gastrointestinal disorders
Hemorrhoids
|
4.2%
1/24 • 6 months
|
|
Gastrointestinal disorders
Mucositis oral
|
20.8%
5/24 • 6 months
|
|
Gastrointestinal disorders
Nausea
|
58.3%
14/24 • 6 months
|
|
Gastrointestinal disorders
Oral pain
|
8.3%
2/24 • 6 months
|
|
Gastrointestinal disorders
Rectal pain
|
4.2%
1/24 • 6 months
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
6/24 • 6 months
|
|
General disorders
Chills
|
16.7%
4/24 • 6 months
|
|
General disorders
Edema limbs
|
12.5%
3/24 • 6 months
|
|
General disorders
Fatigue
|
83.3%
20/24 • 6 months
|
|
General disorders
Fever
|
16.7%
4/24 • 6 months
|
|
General disorders
Flu like symptoms
|
4.2%
1/24 • 6 months
|
|
General disorders
General disorders and administration site conditions - Other, specify: FAILURE TO THRIVE
|
4.2%
1/24 • 6 months
|
|
General disorders
General disorders and administration site conditions - Other, specify: SWEATS X 2 WKS
|
4.2%
1/24 • 6 months
|
|
General disorders
Infusion related reaction
|
8.3%
2/24 • 6 months
|
|
General disorders
Malaise
|
4.2%
1/24 • 6 months
|
|
General disorders
Non-cardiac chest pain
|
12.5%
3/24 • 6 months
|
|
General disorders
Pain
|
25.0%
6/24 • 6 months
|
|
Infections and infestations
Infections and infestations - Other, specify: FOLLICULITIS
|
4.2%
1/24 • 6 months
|
|
Infections and infestations
Infections and infestations - Other, specify: ORAL CANDIDIASIS
|
4.2%
1/24 • 6 months
|
|
Infections and infestations
Infections and infestations - Other, specify: PNA ON CXR
|
4.2%
1/24 • 6 months
|
|
Infections and infestations
Infections and infestations - Other, specify: URI/AUGMENTIN
|
4.2%
1/24 • 6 months
|
|
Infections and infestations
Infections and infestations - Other, specify: URI/LEVAQUIN
|
4.2%
1/24 • 6 months
|
|
Infections and infestations
Infections and infestations - Other, specify: UTI ABX X 10 D
|
4.2%
1/24 • 6 months
|
|
Infections and infestations
Lip infection
|
4.2%
1/24 • 6 months
|
|
Infections and infestations
Nail infection
|
4.2%
1/24 • 6 months
|
|
Infections and infestations
Sinusitis
|
4.2%
1/24 • 6 months
|
|
Infections and infestations
Urinary tract infection
|
8.3%
2/24 • 6 months
|
|
Injury, poisoning and procedural complications
Fall
|
8.3%
2/24 • 6 months
|
|
Injury, poisoning and procedural complications
Postoperative thoracic procedure complication
|
12.5%
3/24 • 6 months
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
4.2%
1/24 • 6 months
|
|
Investigations
Alanine aminotransferase increased
|
8.3%
2/24 • 6 months
|
|
Investigations
Alkaline phosphatase increased
|
4.2%
1/24 • 6 months
|
|
Investigations
Aspartate aminotransferase increased
|
12.5%
3/24 • 6 months
|
|
Investigations
Creatinine increased
|
12.5%
3/24 • 6 months
|
|
Investigations
INR increased
|
8.3%
2/24 • 6 months
|
|
Investigations
Neutrophil count decreased
|
20.8%
5/24 • 6 months
|
|
Investigations
Platelet count decreased
|
41.7%
10/24 • 6 months
|
|
Investigations
Weight loss
|
12.5%
3/24 • 6 months
|
|
Investigations
White blood cell decreased
|
8.3%
2/24 • 6 months
|
|
Metabolism and nutrition disorders
Anorexia
|
41.7%
10/24 • 6 months
|
|
Metabolism and nutrition disorders
Dehydration
|
25.0%
6/24 • 6 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
29.2%
7/24 • 6 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
4.2%
1/24 • 6 months
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
8.3%
2/24 • 6 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
33.3%
8/24 • 6 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
8.3%
2/24 • 6 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
33.3%
8/24 • 6 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
33.3%
8/24 • 6 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
33.3%
8/24 • 6 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
4.2%
1/24 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
58.3%
14/24 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
4.2%
1/24 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
20.8%
5/24 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
8.3%
2/24 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
4.2%
1/24 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify: LEG CRAMPS
|
4.2%
1/24 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify: WEAKNESS GENERAL
|
4.2%
1/24 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
54.2%
13/24 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.3%
2/24 • 6 months
|
|
Nervous system disorders
Akathisia
|
4.2%
1/24 • 6 months
|
|
Nervous system disorders
Dizziness
|
25.0%
6/24 • 6 months
|
|
Nervous system disorders
Dysgeusia
|
37.5%
9/24 • 6 months
|
|
Nervous system disorders
Headache
|
12.5%
3/24 • 6 months
|
|
Nervous system disorders
Paresthesia
|
12.5%
3/24 • 6 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
45.8%
11/24 • 6 months
|
|
Psychiatric disorders
Confusion
|
8.3%
2/24 • 6 months
|
|
Psychiatric disorders
Depression
|
8.3%
2/24 • 6 months
|
|
Psychiatric disorders
Hallucinations
|
4.2%
1/24 • 6 months
|
|
Psychiatric disorders
Insomnia
|
37.5%
9/24 • 6 months
|
|
Psychiatric disorders
Restlessness
|
4.2%
1/24 • 6 months
|
|
Renal and urinary disorders
Acute kidney injury
|
4.2%
1/24 • 6 months
|
|
Renal and urinary disorders
Urinary retention
|
4.2%
1/24 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
4.2%
1/24 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
8.3%
2/24 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
6/24 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
37.5%
9/24 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
8.3%
2/24 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal hemorrhage
|
4.2%
1/24 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
4.2%
1/24 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify: GURGLING IN CHEST
|
4.2%
1/24 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
8.3%
2/24 • 6 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
62.5%
15/24 • 6 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
16.7%
4/24 • 6 months
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
4.2%
1/24 • 6 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
25.0%
6/24 • 6 months
|
|
Skin and subcutaneous tissue disorders
Purpura
|
4.2%
1/24 • 6 months
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
12.5%
3/24 • 6 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
37.5%
9/24 • 6 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: DRY CRACKING FINGER NAILS
|
4.2%
1/24 • 6 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: EXCORIATED COCCYX
|
4.2%
1/24 • 6 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: FOLLICULITIS RT DEXAMETHASONE
|
4.2%
1/24 • 6 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: PEELING HANDS/ARMS/FEET/LEGS
|
4.2%
1/24 • 6 months
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
4.2%
1/24 • 6 months
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
4.2%
1/24 • 6 months
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify
|
4.2%
1/24 • 6 months
|
|
Vascular disorders
Hot flashes
|
4.2%
1/24 • 6 months
|
|
Vascular disorders
Hypotension
|
16.7%
4/24 • 6 months
|
|
Vascular disorders
Thromboembolic event
|
4.2%
1/24 • 6 months
|
|
Vascular disorders
Vascular disorders - Other, specify: DIAPHORESIS,INTERMITTENT W PAIN
|
4.2%
1/24 • 6 months
|
|
Vascular disorders
Vascular disorders - Other, specify: VASODILATORY SHOCK
|
4.2%
1/24 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place