Trial Outcomes & Findings for Infigratinib for the Treatment of Advanced or Metastatic Solid Tumors in Patients With FGFR Gene Mutations (NCT NCT04233567)
NCT ID: NCT04233567
Last Updated: 2025-06-10
Results Overview
Assessed by investigator as per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1. The estimated ORR will be presented along with the corresponding 90% confidence interval for each cohort, based on a binomial distribution. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disappearance of all non-nodal target lesions; Partial Response (PR), at least a 30% decrease in the sum of diameter of all target lesions; Overall Response (OR) = CR + PR
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
17 participants
Primary outcome timeframe
6 cycles of treatment (each cycle is 28 days) or upon treatment discontinuation
Results posted on
2025-06-10
Participant Flow
Participant milestones
| Measure |
Treatment (Infigratinib)
Patients receive infigratinib PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Infigratinib: Given PO
|
|---|---|
|
Overall Study
STARTED
|
17
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Infigratinib for the Treatment of Advanced or Metastatic Solid Tumors in Patients With FGFR Gene Mutations
Baseline characteristics by cohort
| Measure |
Treatment (Infigratinib)
n=17 Participants
Patients receive infigratinib PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Infigratinib: Given PO
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 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
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 cycles of treatment (each cycle is 28 days) or upon treatment discontinuationPopulation: Only 15 patients were evaluable for this outcome measure
Assessed by investigator as per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1. The estimated ORR will be presented along with the corresponding 90% confidence interval for each cohort, based on a binomial distribution. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disappearance of all non-nodal target lesions; Partial Response (PR), at least a 30% decrease in the sum of diameter of all target lesions; Overall Response (OR) = CR + PR
Outcome measures
| Measure |
Treatment (Infigratinib)
n=15 Participants
Patients receive infigratinib PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Infigratinib: Given PO
|
|---|---|
|
Overall Response Rate (ORR)
|
13.3 percentage of participants
Interval 3.6 to 36.1
|
SECONDARY outcome
Timeframe: From start of treatment to the date of the event defined as the first documented progression or death due to any cause, assessed up to 1 year post-treatment, up to 5 yearsPopulation: Only 15 patients were evaluable for this outcome measure
Assessed by investigator as per RECIST v1.1. Kaplan-Meier analysis of PFS will be conducted for each cohort.
Outcome measures
| Measure |
Treatment (Infigratinib)
n=15 Participants
Patients receive infigratinib PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Infigratinib: Given PO
|
|---|---|
|
Progression Free Survival (PFS)
|
3.73 months
Interval 1.87 to 7.1
|
SECONDARY outcome
Timeframe: Up to 1 year post-treatment, up to 5 yearsPopulation: Only 15 patients were evaluable for this outcome measure
Assessed by investigator as per RECIST v1.1.
Outcome measures
| Measure |
Treatment (Infigratinib)
n=15 Participants
Patients receive infigratinib PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Infigratinib: Given PO
|
|---|---|
|
Disease Control Rate
|
73.3 percentage of participants
Interval 50.0 to 87.8
|
SECONDARY outcome
Timeframe: From the date of start of treatment to the date of death due to any cause, will be assessed at 4, 6, 8,12 and 24 monthsPopulation: Only 15 patients were evaluable for this outcome measure
Assessed by investigator as per RECIST v1.1. Will be analyzed using the Kaplan Meier method. Survival rate at 4, 6, 8, 12, 18 and 24 months and median OS will be estimated along with 95% confidence intervals from the Kaplan Meier distribution.
Outcome measures
| Measure |
Treatment (Infigratinib)
n=15 Participants
Patients receive infigratinib PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Infigratinib: Given PO
|
|---|---|
|
Overall Survival (OS)
|
9.37 months
Interval 3.97 to 12.5
|
SECONDARY outcome
Timeframe: Up to 30 days post-treatment, up to 5 yearsWill be tabulated and presented. All AEs occurring during the study will be included in by-patient data listings and tabulated by organ class and preferred term. Adverse events will be summarized overall, by relationship and by severity. Events leading to death, serious (S)AE, and events resulting in treatment discontinuation will be tabulated. Individual patient laboratory parameter values and summary statistics over time will be prepared using descriptive statistics. Severity of select clinical laboratory measures will be determined using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5 criteria .
Outcome measures
| Measure |
Treatment (Infigratinib)
n=17 Participants
Patients receive infigratinib PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Infigratinib: Given PO
|
|---|---|
|
Frequency of Adverse Events (AEs)
Arthralgia
|
12 events
|
|
Frequency of Adverse Events (AEs)
Callus Tenderness
|
1 events
|
|
Frequency of Adverse Events (AEs)
Cataract
|
6 events
|
|
Frequency of Adverse Events (AEs)
Cheilitis
|
1 events
|
|
Frequency of Adverse Events (AEs)
Cholesterol High
|
1 events
|
|
Frequency of Adverse Events (AEs)
Presbyopia
|
1 events
|
|
Frequency of Adverse Events (AEs)
Pseudophakia
|
2 events
|
|
Frequency of Adverse Events (AEs)
Punctate Keratopathy
|
1 events
|
|
Frequency of Adverse Events (AEs)
Rectovaginal Fistula
|
1 events
|
|
Frequency of Adverse Events (AEs)
Rhinitis Sicca
|
1 events
|
|
Frequency of Adverse Events (AEs)
Thromboembolic Event
|
1 events
|
|
Frequency of Adverse Events (AEs)
Toe Intermittent Drainage
|
1 events
|
|
Frequency of Adverse Events (AEs)
Anal Hemorrhage
|
1 events
|
|
Frequency of Adverse Events (AEs)
Anemia
|
6 events
|
|
Frequency of Adverse Events (AEs)
Crawling Sensation on Skin
|
1 events
|
|
Frequency of Adverse Events (AEs)
Arthritis
|
2 events
|
|
Frequency of Adverse Events (AEs)
Back Pain
|
9 events
|
|
Frequency of Adverse Events (AEs)
Bacteremia
|
1 events
|
|
Frequency of Adverse Events (AEs)
Belching
|
1 events
|
|
Frequency of Adverse Events (AEs)
Blepharitis
|
1 events
|
|
Frequency of Adverse Events (AEs)
Bloating
|
3 events
|
|
Frequency of Adverse Events (AEs)
Blurred Vision
|
14 events
|
|
Frequency of Adverse Events (AEs)
Body Aches
|
1 events
|
|
Frequency of Adverse Events (AEs)
Bone Pain
|
2 events
|
|
Frequency of Adverse Events (AEs)
Burning Eyes
|
1 events
|
|
Frequency of Adverse Events (AEs)
Choroid Mild Tortuosity
|
1 events
|
|
Frequency of Adverse Events (AEs)
Chronic Kidney Disease
|
4 events
|
|
Frequency of Adverse Events (AEs)
Constant Eye Pressure
|
1 events
|
|
Frequency of Adverse Events (AEs)
Constipation
|
21 events
|
|
Frequency of Adverse Events (AEs)
Corneal Abrasion
|
4 events
|
|
Frequency of Adverse Events (AEs)
Corneal Ulcer
|
1 events
|
|
Frequency of Adverse Events (AEs)
Creatinine Increased
|
2 events
|
|
Frequency of Adverse Events (AEs)
Corners of Mouth Cracking Open
|
1 events
|
|
Frequency of Adverse Events (AEs)
Cotton Wool Spot
|
1 events
|
|
Frequency of Adverse Events (AEs)
Cough
|
3 events
|
|
Frequency of Adverse Events (AEs)
Covid-19
|
2 events
|
|
Frequency of Adverse Events (AEs)
Dehydration
|
5 events
|
|
Frequency of Adverse Events (AEs)
Depression
|
10 events
|
|
Frequency of Adverse Events (AEs)
Dermatochalasis
|
1 events
|
|
Frequency of Adverse Events (AEs)
Diarrhea
|
14 events
|
|
Frequency of Adverse Events (AEs)
Diplopia
|
1 events
|
|
Frequency of Adverse Events (AEs)
Dizziness
|
2 events
|
|
Frequency of Adverse Events (AEs)
Dry Eye
|
12 events
|
|
Frequency of Adverse Events (AEs)
Dry Mouth
|
11 events
|
|
Frequency of Adverse Events (AEs)
Dry Nose
|
1 events
|
|
Frequency of Adverse Events (AEs)
Dry Skin
|
6 events
|
|
Frequency of Adverse Events (AEs)
Dry Throat
|
1 events
|
|
Frequency of Adverse Events (AEs)
Ear Pain
|
1 events
|
|
Frequency of Adverse Events (AEs)
Edema Face
|
2 events
|
|
Frequency of Adverse Events (AEs)
Edema Limbs
|
9 events
|
|
Frequency of Adverse Events (AEs)
Edema Trunk
|
2 events
|
|
Frequency of Adverse Events (AEs)
Dysgeusia
|
16 events
|
|
Frequency of Adverse Events (AEs)
Epigastric Discomfort
|
1 events
|
|
Frequency of Adverse Events (AEs)
Epistaxis
|
5 events
|
|
Frequency of Adverse Events (AEs)
Eye Infection
|
1 events
|
|
Frequency of Adverse Events (AEs)
Eye Redness
|
2 events
|
|
Frequency of Adverse Events (AEs)
Eyelash Epilation
|
1 events
|
|
Frequency of Adverse Events (AEs)
Fall
|
10 events
|
|
Frequency of Adverse Events (AEs)
Dyspnea
|
16 events
|
|
Frequency of Adverse Events (AEs)
Dysuria
|
1 events
|
|
Frequency of Adverse Events (AEs)
Fatigue
|
56 events
|
|
Frequency of Adverse Events (AEs)
Melena
|
2 events
|
|
Frequency of Adverse Events (AEs)
Fever
|
3 events
|
|
Frequency of Adverse Events (AEs)
Flank Pain
|
5 events
|
|
Frequency of Adverse Events (AEs)
Flatulence
|
1 events
|
|
Frequency of Adverse Events (AEs)
Floaters
|
3 events
|
|
Frequency of Adverse Events (AEs)
Flu Like Symptoms
|
1 events
|
|
Frequency of Adverse Events (AEs)
Fracture
|
1 events
|
|
Frequency of Adverse Events (AEs)
Gait Disturbance
|
3 events
|
|
Frequency of Adverse Events (AEs)
Gastroenteritis
|
1 events
|
|
Frequency of Adverse Events (AEs)
Gastritis
|
1 events
|
|
Frequency of Adverse Events (AEs)
Gastroesophageal Reflux Disease
|
7 events
|
|
Frequency of Adverse Events (AEs)
Gastrointestinal Pain
|
1 events
|
|
Frequency of Adverse Events (AEs)
Gastrointestinal Reflux Disease
|
1 events
|
|
Frequency of Adverse Events (AEs)
Generalized Weakness
|
1 events
|
|
Frequency of Adverse Events (AEs)
Hematuria
|
1 events
|
|
Frequency of Adverse Events (AEs)
Memory Impairment
|
1 events
|
|
Frequency of Adverse Events (AEs)
Metavirus
|
1 events
|
|
Frequency of Adverse Events (AEs)
Hemorrhoidal Hemorrhage
|
2 events
|
|
Frequency of Adverse Events (AEs)
Mucositis oral
|
26 events
|
|
Frequency of Adverse Events (AEs)
Muscle Aches
|
1 events
|
|
Frequency of Adverse Events (AEs)
Muscle Cramp
|
13 events
|
|
Frequency of Adverse Events (AEs)
Myalgia
|
2 events
|
|
Frequency of Adverse Events (AEs)
Nail Changes
|
11 events
|
|
Frequency of Adverse Events (AEs)
Nail Discoloration
|
5 events
|
|
Frequency of Adverse Events (AEs)
Nail Lifting
|
9 events
|
|
Frequency of Adverse Events (AEs)
Hoarseness
|
1 events
|
|
Frequency of Adverse Events (AEs)
Hypercalcemia
|
4 events
|
|
Frequency of Adverse Events (AEs)
Hyperglycemia
|
5 events
|
|
Frequency of Adverse Events (AEs)
Hyperphosphatemia
|
8 events
|
|
Frequency of Adverse Events (AEs)
Hypertension
|
2 events
|
|
Frequency of Adverse Events (AEs)
Hypertrichosis
|
1 events
|
|
Frequency of Adverse Events (AEs)
Hypertriglyceridemia
|
8 events
|
|
Frequency of Adverse Events (AEs)
Hypoalbuminemia
|
5 events
|
|
Frequency of Adverse Events (AEs)
Hypocalcemia
|
1 events
|
|
Frequency of Adverse Events (AEs)
Hyponatremia
|
7 events
|
|
Frequency of Adverse Events (AEs)
Hypophosphatemia
|
5 events
|
|
Frequency of Adverse Events (AEs)
Hypotension
|
4 events
|
|
Frequency of Adverse Events (AEs)
Hypothyroidism
|
1 events
|
|
Frequency of Adverse Events (AEs)
Hypoxemia Post Monoclonal Antibody Infusion
|
1 events
|
|
Frequency of Adverse Events (AEs)
Insomnia
|
6 events
|
|
Frequency of Adverse Events (AEs)
Intermittent Phlegm
|
1 events
|
|
Frequency of Adverse Events (AEs)
Keratitis
|
6 events
|
|
Frequency of Adverse Events (AEs)
Keratopathy
|
1 events
|
|
Frequency of Adverse Events (AEs)
Lip Blister
|
1 events
|
|
Frequency of Adverse Events (AEs)
Glaucoma
|
1 events
|
|
Frequency of Adverse Events (AEs)
Gritty Eyes
|
1 events
|
|
Frequency of Adverse Events (AEs)
Headache
|
6 events
|
|
Frequency of Adverse Events (AEs)
Paronychia
|
9 events
|
|
Frequency of Adverse Events (AEs)
Pelvic pain
|
1 events
|
|
Frequency of Adverse Events (AEs)
Periorbital Edema
|
1 events
|
|
Frequency of Adverse Events (AEs)
Peripheral Motor Neuropathy
|
2 events
|
|
Frequency of Adverse Events (AEs)
Peripheral Sensory Neuropathy
|
21 events
|
|
Frequency of Adverse Events (AEs)
Platelet Count Decreased
|
2 events
|
|
Frequency of Adverse Events (AEs)
Pleural effusion
|
3 events
|
|
Frequency of Adverse Events (AEs)
Pneumonia
|
1 events
|
|
Frequency of Adverse Events (AEs)
Port Site Redness
|
1 events
|
|
Frequency of Adverse Events (AEs)
Nail Loss
|
10 events
|
|
Frequency of Adverse Events (AEs)
Nail Ridges
|
4 events
|
|
Frequency of Adverse Events (AEs)
Nasal Congestion
|
3 events
|
|
Frequency of Adverse Events (AEs)
Nasal Mucosa Irritation
|
1 events
|
|
Frequency of Adverse Events (AEs)
Nasal Sores
|
1 events
|
|
Frequency of Adverse Events (AEs)
Nausea
|
19 events
|
|
Frequency of Adverse Events (AEs)
Neck Pain
|
2 events
|
|
Frequency of Adverse Events (AEs)
Non-cardiac Chest Pain
|
2 events
|
|
Frequency of Adverse Events (AEs)
Non-neurovascular Age Related Macular Degeneration
|
1 events
|
|
Frequency of Adverse Events (AEs)
Onychauxis
|
1 events
|
|
Frequency of Adverse Events (AEs)
Oral Dysesthesia
|
1 events
|
|
Frequency of Adverse Events (AEs)
Oral Pain
|
2 events
|
|
Frequency of Adverse Events (AEs)
Otitis Externa
|
1 events
|
|
Frequency of Adverse Events (AEs)
Overactive Bladder
|
1 events
|
|
Frequency of Adverse Events (AEs)
Pain in Extremity
|
19 events
|
|
Frequency of Adverse Events (AEs)
Pain of Skin
|
3 events
|
|
Frequency of Adverse Events (AEs)
Pain
|
28 events
|
|
Frequency of Adverse Events (AEs)
Posterior Vitreous Detachment Posterior Vitreous Detachment
|
1 events
|
|
Frequency of Adverse Events (AEs)
Palmar-plantar Erythrodysesthesia Syndrome
|
6 events
|
|
Frequency of Adverse Events (AEs)
Paresthesia
|
1 events
|
|
Frequency of Adverse Events (AEs)
Productive Cough
|
5 events
|
|
Frequency of Adverse Events (AEs)
Pruritus
|
1 events
|
|
Frequency of Adverse Events (AEs)
Rash Maculo-papular
|
6 events
|
|
Frequency of Adverse Events (AEs)
Rash
|
2 events
|
|
Frequency of Adverse Events (AEs)
Retinal Hemorrhage
|
1 events
|
|
Frequency of Adverse Events (AEs)
Retinal Vascular Disorder
|
1 events
|
|
Frequency of Adverse Events (AEs)
Retinopathy
|
2 events
|
|
Frequency of Adverse Events (AEs)
Shingles
|
1 events
|
|
Frequency of Adverse Events (AEs)
Sinus Tachycardia
|
2 events
|
|
Frequency of Adverse Events (AEs)
Small Intestinal Obstruction
|
2 events
|
|
Frequency of Adverse Events (AEs)
Sore Throat
|
6 events
|
|
Frequency of Adverse Events (AEs)
Syncope
|
1 events
|
|
Frequency of Adverse Events (AEs)
Teeth Extraction
|
1 events
|
|
Frequency of Adverse Events (AEs)
Thrush
|
2 events
|
|
Frequency of Adverse Events (AEs)
Vaginal Pain
|
2 events
|
|
Frequency of Adverse Events (AEs)
Vomiting
|
12 events
|
|
Frequency of Adverse Events (AEs)
Watering Eyes
|
8 events
|
|
Frequency of Adverse Events (AEs)
Weight Gain
|
4 events
|
|
Frequency of Adverse Events (AEs)
Lipase Increased
|
2 events
|
|
Frequency of Adverse Events (AEs)
Localized Edema
|
3 events
|
|
Frequency of Adverse Events (AEs)
Lymphocyte Count Decreased
|
1 events
|
|
Frequency of Adverse Events (AEs)
Tooth Infection
|
1 events
|
|
Frequency of Adverse Events (AEs)
Tremor
|
1 events
|
|
Frequency of Adverse Events (AEs)
Trichiasis
|
2 events
|
|
Frequency of Adverse Events (AEs)
Trichomegaly
|
1 events
|
|
Frequency of Adverse Events (AEs)
Trochanteric Bursitis
|
1 events
|
|
Frequency of Adverse Events (AEs)
Vaginal Discharge
|
1 events
|
|
Frequency of Adverse Events (AEs)
Weight Loss
|
23 events
|
|
Frequency of Adverse Events (AEs)
Wheezing
|
1 events
|
|
Frequency of Adverse Events (AEs)
Abdominal Cramping
|
1 events
|
|
Frequency of Adverse Events (AEs)
Abdominal Pain
|
18 events
|
|
Frequency of Adverse Events (AEs)
Alanine Aminotransferase Increased
|
1 events
|
|
Frequency of Adverse Events (AEs)
Alkaline Phosphatase Increased
|
3 events
|
|
Frequency of Adverse Events (AEs)
Allergic Reaction
|
1 events
|
|
Frequency of Adverse Events (AEs)
Allergic Rhinitis
|
2 events
|
|
Frequency of Adverse Events (AEs)
Alopecia
|
4 events
|
|
Frequency of Adverse Events (AEs)
Anorexia
|
20 events
|
|
Frequency of Adverse Events (AEs)
Anxiety
|
2 events
|
Adverse Events
Treatment (Infigratinib)
Serious events: 4 serious events
Other events: 17 other events
Deaths: 13 deaths
Serious adverse events
| Measure |
Treatment (Infigratinib)
n=17 participants at risk
Patients receive infigratinib PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Infigratinib: Given PO
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Immune system disorders
Covid-19
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Gasteroenteritis
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Infections and infestations
Metavirus
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
5.9%
1/17 • Number of events 2 • Up to 5 years
|
Other adverse events
| Measure |
Treatment (Infigratinib)
n=17 participants at risk
Patients receive infigratinib PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Infigratinib: Given PO
|
|---|---|
|
Gastrointestinal disorders
Teeth Extraction
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Abdominal Cramping
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Abdominal Pain
|
52.9%
9/17 • Number of events 18 • Up to 5 years
|
|
Investigations
Alanine Aminotransferase Increased
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Investigations
Alkaline Phosphatase Increased
|
11.8%
2/17 • Number of events 3 • Up to 5 years
|
|
Immune system disorders
Allergic Reaction
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
11.8%
2/17 • Number of events 2 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
23.5%
4/17 • Number of events 4 • Up to 5 years
|
|
Blood and lymphatic system disorders
Anemia
|
29.4%
5/17 • Number of events 6 • Up to 5 years
|
|
Metabolism and nutrition disorders
Anorexia
|
64.7%
11/17 • Number of events 20 • Up to 5 years
|
|
Psychiatric disorders
Anxiety
|
11.8%
2/17 • Number of events 2 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
29.4%
5/17 • Number of events 12 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
11.8%
2/17 • Number of events 2 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
35.3%
6/17 • Number of events 9 • Up to 5 years
|
|
Infections and infestations
Bacteremia
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Belching
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Bloating
|
17.6%
3/17 • Number of events 3 • Up to 5 years
|
|
Blood and lymphatic system disorders
Hypoxemia Post Monoclonal Antibody Infusion
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Eye disorders
Blurred Vision
|
47.1%
8/17 • Number of events 14 • Up to 5 years
|
|
General disorders
Body Aches
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Eye disorders
Cataract
|
23.5%
4/17 • Number of events 6 • Up to 5 years
|
|
Gastrointestinal disorders
Cheilitis
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Investigations
Cholesterol High
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Renal and urinary disorders
Chronic Kidney Disease
|
11.8%
2/17 • Number of events 4 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
17.6%
3/17 • Number of events 3 • Up to 5 years
|
|
Gastrointestinal disorders
Constipation
|
76.5%
13/17 • Number of events 21 • Up to 5 years
|
|
Eye disorders
Corneal Ulcer
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
17.6%
3/17 • Number of events 3 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
17.6%
3/17 • Number of events 5 • Up to 5 years
|
|
Investigations
Creatinine Increased
|
11.8%
2/17 • Number of events 2 • Up to 5 years
|
|
Investigations
Platelet Count Decreased
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Metabolism and nutrition disorders
Dehydration
|
29.4%
5/17 • Number of events 5 • Up to 5 years
|
|
Psychiatric disorders
Depression
|
47.1%
8/17 • Number of events 10 • Up to 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
52.9%
9/17 • Number of events 14 • Up to 5 years
|
|
Nervous system disorders
Dizziness
|
11.8%
2/17 • Number of events 2 • Up to 5 years
|
|
Eye disorders
Dry Eye
|
47.1%
8/17 • Number of events 12 • Up to 5 years
|
|
Gastrointestinal disorders
Dry Mouth
|
58.8%
10/17 • Number of events 11 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
29.4%
5/17 • Number of events 6 • Up to 5 years
|
|
Nervous system disorders
Dysgeusia
|
52.9%
9/17 • Number of events 16 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
47.1%
8/17 • Number of events 16 • Up to 5 years
|
|
Renal and urinary disorders
Dysuria
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Ear and labyrinth disorders
Ear Pain
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
General disorders
Edema Limbs
|
29.4%
5/17 • Number of events 9 • Up to 5 years
|
|
General disorders
Edema Trunk
|
11.8%
2/17 • Number of events 2 • Up to 5 years
|
|
General disorders
Edema Face
|
11.8%
2/17 • Number of events 2 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
29.4%
5/17 • Number of events 5 • Up to 5 years
|
|
Eye disorders
Eye Redness
|
11.8%
2/17 • Number of events 2 • Up to 5 years
|
|
Eye disorders
Burning Eyes
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Eye disorders
Choroid Mild Tortuosity
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Eye disorders
Trichiasis
|
11.8%
2/17 • Number of events 2 • Up to 5 years
|
|
Eye disorders
Corneal Abrasion
|
5.9%
1/17 • Number of events 4 • Up to 5 years
|
|
Eye disorders
Cotton Wool Spot
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Eye disorders
Diplopia
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Eye disorders
Punctate Keratopathy
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Eye disorders
Gritty Eyes
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Eye disorders
Posterior Vitreous Detachment
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Eye disorders
Retinal Hemorrhage
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Eye disorders
Trichomegaly
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Eye disorders
Blepharitis
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Eye disorders
Constant Eye Pressure
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Eye disorders
Pseudophakia
|
5.9%
1/17 • Number of events 2 • Up to 5 years
|
|
Eye disorders
Presbyopia
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Eye disorders
Dermatochalasis
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Eye disorders
Keratopathy
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Eye disorders
Eye Infection
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Eye disorders
Eyelash Epilation
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Injury, poisoning and procedural complications
Fall
|
23.5%
4/17 • Number of events 10 • Up to 5 years
|
|
General disorders
Fatigue
|
100.0%
17/17 • Number of events 56 • Up to 5 years
|
|
General disorders
Fever
|
11.8%
2/17 • Number of events 3 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
11.8%
2/17 • Number of events 5 • Up to 5 years
|
|
Gastrointestinal disorders
Flatulence
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Eye disorders
Floaters
|
17.6%
3/17 • Number of events 3 • Up to 5 years
|
|
General disorders
Flu Like Symptoms
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Injury, poisoning and procedural complications
Fracture
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
General disorders
Gait Distrubance
|
5.9%
1/17 • Number of events 3 • Up to 5 years
|
|
Gastrointestinal disorders
Gastritis
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
35.3%
6/17 • Number of events 7 • Up to 5 years
|
|
Gastrointestinal disorders
Dry Nose
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Rectovaginal Fistula
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Dry Throat
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Epigastric Discomfort
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Gastrointestinal Pain
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Gastrointestinal Reflux Disease
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
General disorders
Generalized Weakness
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Eye disorders
Glaucoma
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Nervous system disorders
Headache
|
23.5%
4/17 • Number of events 6 • Up to 5 years
|
|
Renal and urinary disorders
Hematuria
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Hemorrhoidal Hemorrhage
|
11.8%
2/17 • Number of events 2 • Up to 5 years
|
|
Gastrointestinal disorders
Anal Hemorrhage
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
17.6%
3/17 • Number of events 4 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
17.6%
3/17 • Number of events 5 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
41.2%
7/17 • Number of events 8 • Up to 5 years
|
|
Vascular disorders
Hypertension
|
11.8%
2/17 • Number of events 2 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Hypertrichosis
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
17.6%
3/17 • Number of events 8 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
17.6%
3/17 • Number of events 5 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
17.6%
3/17 • Number of events 7 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
11.8%
2/17 • Number of events 5 • Up to 5 years
|
|
Vascular disorders
Hypotension
|
17.6%
3/17 • Number of events 4 • Up to 5 years
|
|
Endocrine disorders
Hypothyroidism
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Infections and infestations
Covid-19
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Psychiatric disorders
Insomnia
|
35.3%
6/17 • Number of events 6 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Intermittent Phlegm
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Eye disorders
Keratitis
|
11.8%
2/17 • Number of events 6 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
11.8%
2/17 • Number of events 3 • Up to 5 years
|
|
Investigations
Lipase Increased
|
11.8%
2/17 • Number of events 2 • Up to 5 years
|
|
General disorders
Localized Edema
|
17.6%
3/17 • Number of events 3 • Up to 5 years
|
|
Infections and infestations
Pneumonia
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Investigations
Lymphocyte Count Decreased
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Melena
|
11.8%
2/17 • Number of events 2 • Up to 5 years
|
|
Nervous system disorders
Memory Impairment
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Mucositis oral
|
76.5%
13/17 • Number of events 26 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Muscle Cramp
|
29.4%
5/17 • Number of events 13 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Muscle Aches
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Trochanteric Bursitis
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.8%
2/17 • Number of events 2 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Nail Changes
|
52.9%
9/17 • Number of events 11 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Nail Discoloration
|
29.4%
5/17 • Number of events 5 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Nail Lifting
|
29.4%
5/17 • Number of events 9 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Nail Loss
|
17.6%
3/17 • Number of events 10 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Nail Ridges
|
23.5%
4/17 • Number of events 4 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Sores
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Nausea
|
64.7%
11/17 • Number of events 19 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
5.9%
1/17 • Number of events 2 • Up to 5 years
|
|
General disorders
Non-cardiac Chest Pain
|
11.8%
2/17 • Number of events 2 • Up to 5 years
|
|
Eye disorders
Non-neurovascular Age Related Macular Degeneration
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Onychauxis
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Oral Dysesthesia
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Oral Pain
|
11.8%
2/17 • Number of events 2 • Up to 5 years
|
|
Infections and infestations
Otitis Externa
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Renal and urinary disorders
Overactive Bladder
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Pain of Skin
|
17.6%
3/17 • Number of events 3 • Up to 5 years
|
|
General disorders
Pain
|
47.1%
8/17 • Number of events 28 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
41.2%
7/17 • Number of events 19 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar Erythrodysesthesia Syndrome
|
17.6%
3/17 • Number of events 6 • Up to 5 years
|
|
Nervous system disorders
Paresthesia
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Infections and infestations
Paronychia
|
29.4%
5/17 • Number of events 9 • Up to 5 years
|
|
Reproductive system and breast disorders
Pelvic pain
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Eye disorders
Periorbital Edema
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Nervous system disorders
Peripheral Motor Neuropathy
|
5.9%
1/17 • Number of events 2 • Up to 5 years
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
82.4%
14/17 • Number of events 21 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-papular
|
23.5%
4/17 • Number of events 6 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.8%
2/17 • Number of events 2 • Up to 5 years
|
|
General disorders
Port Site Redness
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Sicca
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Eye disorders
Retinal Vascular Disorder
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Eye disorders
Retinopathy
|
11.8%
2/17 • Number of events 2 • Up to 5 years
|
|
Infections and infestations
Shingles
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Cardiac disorders
Sinus Tachycardia
|
11.8%
2/17 • Number of events 2 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Lip Blister
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Crawling Sensation on Skin
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Callus Tenderness
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Corners of Mouth Cracking Open
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Nasal Mucosa Irritation
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Toe Intermittent Drainage
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
23.5%
4/17 • Number of events 6 • Up to 5 years
|
|
Nervous system disorders
Syncope
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Vascular disorders
Thromboembolic Event
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Infections and infestations
Thrush
|
11.8%
2/17 • Number of events 2 • Up to 5 years
|
|
Infections and infestations
Tooth Infection
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Nervous system disorders
Tremor
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Reproductive system and breast disorders
Vaginal Discharge
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
|
Reproductive system and breast disorders
Vaginal Pain
|
11.8%
2/17 • Number of events 2 • Up to 5 years
|
|
Gastrointestinal disorders
Vomiting
|
41.2%
7/17 • Number of events 12 • Up to 5 years
|
|
Eye disorders
Watering Eyes
|
47.1%
8/17 • Number of events 8 • Up to 5 years
|
|
Investigations
Weight Gain
|
5.9%
1/17 • Number of events 4 • Up to 5 years
|
|
Investigations
Weight Loss
|
64.7%
11/17 • Number of events 23 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
Additional Information
Dr. Sameek Roychowdhury
The Ohio State University Comprehensive Cancer Center
Phone: 614-685-5842
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place