Trial Outcomes & Findings for Sutent + Taxol for Advanced Esophageal Cancer (NCT NCT00730353)
NCT ID: NCT00730353
Last Updated: 2017-03-16
Results Overview
To determine the rate of non-progressive disease at 24 weeks from the first dose of the combination of sunitinib malate and paclitaxel in advanced esophageal carcinoma, where progression is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
28 participants
Primary outcome timeframe
24 weeks
Results posted on
2017-03-16
Participant Flow
Trial opened to accrual November 2008; opened at both community and academic performance sites.
This trial was limited to patients with advanced esophageal cancer.
Participant milestones
| Measure |
Paclitaxel and Sutinib Malate
Treatment will be administered on an outpatient basis. Chemotherapy will be administered in a 28-day treatment cycle. The 28 days of treatment with paclitaxel and sunitinib malate (plus the time required to recover if toxicity is encountered) is defined as a cycle.
* Paclitaxel 90 mg/m2 IV on days 1, 8 and 15.
* Sunitinib malate 37.5 mg orally, daily. After 4 cycles, paclitaxel will be discontinued and patients will continue on sunitinib malate until disease progression, unacceptable toxicity, or physician discretion.
|
|---|---|
|
Overall Study
STARTED
|
28
|
|
Overall Study
COMPLETED
|
28
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sutent + Taxol for Advanced Esophageal Cancer
Baseline characteristics by cohort
| Measure |
Paclitaxel and Sutinib Malate
n=28 Participants
Treatment will be administered on an outpatient basis. Chemotherapy will be administered in a 28-day treatment cycle. The 28 days of treatment with paclitaxel and sunitinib malate (plus the time required to recover if toxicity is encountered) is defined as a cycle.
* Paclitaxel 90 mg/m2 IV on days 1, 8 and 15.
* Sunitinib malate 37.5 mg orally, daily. After 4 cycles, paclitaxel will be discontinued and patients will continue on sunitinib malate until disease progression, unacceptable toxicity, or physician discretion.
|
|---|---|
|
Age, Continuous
|
59.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
ECOG PS 0
|
15 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
ECOG PS 1
|
11 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
ECOG PS 2
|
2 Participants
n=5 Participants
|
|
Tumor Site
Esophagus
|
22 participants
n=5 Participants
|
|
Tumor Site
Gastroesophageal Junction
|
6 participants
n=5 Participants
|
|
Histology
Adenocarcinoma
|
26 participants
n=5 Participants
|
|
Histology
Squamous cell carcinoma
|
2 participants
n=5 Participants
|
|
Prior Treatment
Yes
|
11 participants
n=5 Participants
|
|
Prior Treatment
No
|
17 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: Intent to treat - all enrolled participants
To determine the rate of non-progressive disease at 24 weeks from the first dose of the combination of sunitinib malate and paclitaxel in advanced esophageal carcinoma, where progression is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions
Outcome measures
| Measure |
Paclitaxel and Sutinib Malate
n=28 Participants
Treatment will be administered on an outpatient basis. Chemotherapy will be administered in a 28-day treatment cycle. The 28 days of treatment with paclitaxel and sunitinib malate (plus the time required to recover if toxicity is encountered) is defined as a cycle.
* Paclitaxel 90 mg/m2 IV on days 1, 8 and 15.
* Sunitinib malate 37.5 mg orally, daily. After 4 cycles, paclitaxel will be discontinued and patients will continue on sunitinib malate until disease progression, unacceptable toxicity, or physician discretion.
|
|---|---|
|
Progression Free Survival Rate at 24 Weeks
|
25 percentage of participants
Interval 12.0 to 42.0
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Evaluable patients, as previously defined.
To determine the response rate for the combination of sunitinib malate and paclitaxel in advanced esophageal carcinoma per RECIST criteria.
Outcome measures
| Measure |
Paclitaxel and Sutinib Malate
n=23 Participants
Treatment will be administered on an outpatient basis. Chemotherapy will be administered in a 28-day treatment cycle. The 28 days of treatment with paclitaxel and sunitinib malate (plus the time required to recover if toxicity is encountered) is defined as a cycle.
* Paclitaxel 90 mg/m2 IV on days 1, 8 and 15.
* Sunitinib malate 37.5 mg orally, daily. After 4 cycles, paclitaxel will be discontinued and patients will continue on sunitinib malate until disease progression, unacceptable toxicity, or physician discretion.
|
|---|---|
|
Response Rate
|
13 percentage of participants
Interval 3.0 to 25.0
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: All participants on an intent-to-treat basis
To determine the one year overall survival rate for the combination of sunitinib malate and paclitaxel in advanced esophageal carcinoma
Outcome measures
| Measure |
Paclitaxel and Sutinib Malate
n=28 Participants
Treatment will be administered on an outpatient basis. Chemotherapy will be administered in a 28-day treatment cycle. The 28 days of treatment with paclitaxel and sunitinib malate (plus the time required to recover if toxicity is encountered) is defined as a cycle.
* Paclitaxel 90 mg/m2 IV on days 1, 8 and 15.
* Sunitinib malate 37.5 mg orally, daily. After 4 cycles, paclitaxel will be discontinued and patients will continue on sunitinib malate until disease progression, unacceptable toxicity, or physician discretion.
|
|---|---|
|
Overall Survival
|
20 percentage of participants
Interval 9.0 to 34.0
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Intention-to-treat patients
To determine the time to progression for the combination of sunitinib malate and paclitaxel in advanced esophageal carcinoma per RECIST criteria.
Outcome measures
| Measure |
Paclitaxel and Sutinib Malate
n=28 Participants
Treatment will be administered on an outpatient basis. Chemotherapy will be administered in a 28-day treatment cycle. The 28 days of treatment with paclitaxel and sunitinib malate (plus the time required to recover if toxicity is encountered) is defined as a cycle.
* Paclitaxel 90 mg/m2 IV on days 1, 8 and 15.
* Sunitinib malate 37.5 mg orally, daily. After 4 cycles, paclitaxel will be discontinued and patients will continue on sunitinib malate until disease progression, unacceptable toxicity, or physician discretion.
|
|---|---|
|
Progression-Free Survival
|
112 Days
Interval 54.0 to 150.0
|
SECONDARY outcome
Timeframe: 16 monthsDetermine the most frequent toxicities associated with the treatment regimen, per the CTCAE version 3 (Common Toxicity Criteria for Adverse Events) criteria.
Outcome measures
| Measure |
Paclitaxel and Sutinib Malate
n=28 Participants
Treatment will be administered on an outpatient basis. Chemotherapy will be administered in a 28-day treatment cycle. The 28 days of treatment with paclitaxel and sunitinib malate (plus the time required to recover if toxicity is encountered) is defined as a cycle.
* Paclitaxel 90 mg/m2 IV on days 1, 8 and 15.
* Sunitinib malate 37.5 mg orally, daily. After 4 cycles, paclitaxel will be discontinued and patients will continue on sunitinib malate until disease progression, unacceptable toxicity, or physician discretion.
|
|---|---|
|
Toxicity Profile
Leukopenia/neutropenia: Grade 3/4
|
7 instances of adverse event
|
|
Toxicity Profile
Anemia: Grade 3/4
|
5 instances of adverse event
|
|
Toxicity Profile
Thrombocytopenia
|
1 instances of adverse event
|
|
Toxicity Profile
Febrile Neutropenia
|
1 instances of adverse event
|
Adverse Events
Paclitaxel and Sutinib Malate
Serious events: 14 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Paclitaxel and Sutinib Malate
n=28 participants at risk
Treatment will be administered on an outpatient basis. Chemotherapy will be administered in a 28-day treatment cycle. The 28 days of treatment with paclitaxel and sunitinib malate (plus the time required to recover if toxicity is encountered) is defined as a cycle.
* Paclitaxel 90 mg/m2 IV on days 1, 8 and 15.
* Sunitinib malate 37.5 mg orally, daily. After 4 cycles, paclitaxel will be discontinued and patients will continue on sunitinib malate until disease progression, unacceptable toxicity, or physician discretion.
|
|---|---|
|
Immune system disorders
ALLERGIC REACTION/HYPERSENSITIVITY (INCLUDING DRUG FEVER)
|
3.6%
1/28 • Number of events 4 • 1 year
|
|
Investigations
CALCIUM, SERUM-LOW (HYPOCALCEMIA)
|
3.6%
1/28 • Number of events 2 • 1 year
|
|
General disorders
DEATH NOT ASSOCIATED WITH CTCAE TERM / DEATH NOS
|
3.6%
1/28 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
DERMATOLOGY/SKIN - OTHER
|
3.6%
1/28 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
DYSPHAGIA (DIFFICULTY SWALLOWING)
|
3.6%
1/28 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA (SHORTNESS OF BREATH)
|
3.6%
1/28 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
FISTULA, GI / ESOPHAGUS
|
3.6%
1/28 • Number of events 1 • 1 year
|
|
Blood and lymphatic system disorders
HEMOGLOBIN
|
3.6%
1/28 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
HEMORRHAGE, GI / ESOPHAGUS
|
3.6%
1/28 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
HEMORRHAGE, GI / STOMACH
|
3.6%
1/28 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
HEMORRHAGE, GI / UPPER GI NOS
|
3.6%
1/28 • Number of events 1 • 1 year
|
|
General disorders
HEMORRHAGE/BLEEDING - OTHER
|
3.6%
1/28 • Number of events 1 • 1 year
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / BONE (OSTEOMYELITIS)
|
3.6%
1/28 • Number of events 1 • 1 year
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / SKIN (CELLULITIS)
|
3.6%
1/28 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) / WHOLE BODY/GENERALIZED
|
3.6%
1/28 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
PAIN / CHEST/THORAX NOS
|
3.6%
1/28 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION (NON-MALIGNANT)
|
3.6%
1/28 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY/UPPER RESPIRATORY - OTHER
|
7.1%
2/28 • Number of events 2 • 1 year
|
|
Cardiac disorders
SUPRAVENTRICULAR AND NODAL ARRHYTHMIA / ATRIAL FLUTTER
|
3.6%
1/28 • Number of events 1 • 1 year
|
|
Vascular disorders
THROMBOSIS/THROMBUS/EMBOLISM
|
7.1%
2/28 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
VOMITING
|
3.6%
1/28 • Number of events 1 • 1 year
|
|
General disorders
WEIGHT LOSS
|
3.6%
1/28 • Number of events 1 • 1 year
|
Other adverse events
| Measure |
Paclitaxel and Sutinib Malate
n=28 participants at risk
Treatment will be administered on an outpatient basis. Chemotherapy will be administered in a 28-day treatment cycle. The 28 days of treatment with paclitaxel and sunitinib malate (plus the time required to recover if toxicity is encountered) is defined as a cycle.
* Paclitaxel 90 mg/m2 IV on days 1, 8 and 15.
* Sunitinib malate 37.5 mg orally, daily. After 4 cycles, paclitaxel will be discontinued and patients will continue on sunitinib malate until disease progression, unacceptable toxicity, or physician discretion.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
PAIN / JOINT
|
10.7%
3/28 • Number of events 3 • 1 year
|
|
Gastrointestinal disorders
PAIN / ORAL-GUMS
|
3.6%
1/28 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
PAIN / RECTUM
|
3.6%
1/28 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
PAIN / STOMACH
|
3.6%
1/28 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
PAIN / THROAT/PHARYNX/LARYNX
|
7.1%
2/28 • Number of events 3 • 1 year
|
|
General disorders
PAIN / TUMOR PAIN
|
3.6%
1/28 • Number of events 1 • 1 year
|
|
General disorders
PAIN - OTHER
|
14.3%
4/28 • Number of events 5 • 1 year
|
|
Blood and lymphatic system disorders
PLATELETS
|
17.9%
5/28 • Number of events 11 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS/PULMONARY INFILTRATES
|
3.6%
1/28 • Number of events 1 • 1 year
|
|
Investigations
POTASSIUM, SERUM-HIGH (HYPERKALEMIA)
|
7.1%
2/28 • Number of events 4 • 1 year
|
|
Investigations
POTASSIUM, SERUM-LOW (HYPOKALEMIA)
|
3.6%
1/28 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
PRURITUS/ITCHING
|
3.6%
1/28 • Number of events 1 • 1 year
|
|
Surgical and medical procedures
PTT (PARTIAL THROMBOPLASTIN TIME)
|
3.6%
1/28 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY/UPPER RESPIRATORY - OTHER
|
3.6%
1/28 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
RASH/DESQUAMATION
|
14.3%
4/28 • Number of events 5 • 1 year
|
|
Skin and subcutaneous tissue disorders
RASH: ACNE/ACNEIFORM
|
7.1%
2/28 • Number of events 2 • 1 year
|
|
Skin and subcutaneous tissue disorders
RASH: HAND-FOOT SKIN REACTION
|
10.7%
3/28 • Number of events 4 • 1 year
|
|
General disorders
RIGORS/CHILLS
|
17.9%
5/28 • Number of events 6 • 1 year
|
|
Gastrointestinal disorders
SALIVARY GLAND CHANGES/SALIVA
|
3.6%
1/28 • Number of events 1 • 1 year
|
|
Investigations
SODIUM, SERUM-LOW (HYPONATREMIA)
|
17.9%
5/28 • Number of events 7 • 1 year
|
|
Investigations
ALBUMIN, SERUM-LOW (HYPOALBUMINEMIA)
|
10.7%
3/28 • Number of events 3 • 1 year
|
|
Investigations
ALKALINE PHOSPHATASE
|
32.1%
9/28 • Number of events 16 • 1 year
|
|
Immune system disorders
ALLERGIC REACTION/HYPERSENSITIVITY (INCLUDING DRUG FEVER)
|
7.1%
2/28 • Number of events 2 • 1 year
|
|
Investigations
ALT, SGPT (SERUM GLUTAMIC PYRUVIC TRANSAMINASE)
|
14.3%
4/28 • Number of events 6 • 1 year
|
|
Investigations
AMYLASE
|
3.6%
1/28 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
ANOREXIA
|
71.4%
20/28 • Number of events 24 • 1 year
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS (NON-SEPTIC)
|
7.1%
2/28 • Number of events 2 • 1 year
|
|
Investigations
AST, SGOT(SERUM GLUTAMIC OXALOACETIC TRANSAMINASE)
|
28.6%
8/28 • Number of events 15 • 1 year
|
|
Investigations
BILIRUBIN (HYPERBILIRUBINEMIA)
|
7.1%
2/28 • Number of events 3 • 1 year
|
|
Investigations
CALCIUM, SERUM-LOW (HYPOCALCEMIA)
|
3.6%
1/28 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
CONSTIPATION
|
42.9%
12/28 • Number of events 19 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
42.9%
12/28 • Number of events 19 • 1 year
|
|
Renal and urinary disorders
CYSTITIS
|
3.6%
1/28 • Number of events 1 • 1 year
|
|
Immune system disorders
CYTOKINE RELEASE SYNDROME/ACUTE INFUSION REACTION
|
7.1%
2/28 • Number of events 4 • 1 year
|
|
Gastrointestinal disorders
DEHYDRATION
|
10.7%
3/28 • Number of events 4 • 1 year
|
|
Gastrointestinal disorders
DIARRHEA
|
42.9%
12/28 • Number of events 27 • 1 year
|
|
Nervous system disorders
DIZZINESS
|
14.3%
4/28 • Number of events 4 • 1 year
|
|
Gastrointestinal disorders
DRY MOUTH/SALIVARY GLAND (XEROSTOMIA)
|
10.7%
3/28 • Number of events 3 • 1 year
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
7.1%
2/28 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
DYSPHAGIA (DIFFICULTY SWALLOWING)
|
46.4%
13/28 • Number of events 18 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA (SHORTNESS OF BREATH)
|
46.4%
13/28 • Number of events 18 • 1 year
|
|
Blood and lymphatic system disorders
EDEMA: LIMB
|
10.7%
3/28 • Number of events 3 • 1 year
|
|
Blood and lymphatic system disorders
EDEMA: TRUNK/GENITAL
|
3.6%
1/28 • Number of events 1 • 1 year
|
|
Endocrine disorders
ENDOCRINE - OTHER
|
3.6%
1/28 • Number of events 1 • 1 year
|
|
General disorders
FATIGUE (ASTHENIA, LETHARGY, MALAISE)
|
82.1%
23/28 • Number of events 52 • 1 year
|
|
Infections and infestations
FEBRILE NEUTROPENIA (ANC <1.0 X 10E9/L, FEVER >=38.5 DEGREES C)
|
3.6%
1/28 • Number of events 1 • 1 year
|
|
General disorders
FEVER
|
3.6%
1/28 • Number of events 1 • 1 year
|
|
General disorders
FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L)
|
10.7%
3/28 • Number of events 3 • 1 year
|
|
Gastrointestinal disorders
FISTULA, GI / ESOPHAGUS
|
7.1%
2/28 • Number of events 2 • 1 year
|
|
Skin and subcutaneous tissue disorders
FLUSHING
|
7.1%
2/28 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
GASTROINTESTINAL - OTHER
|
3.6%
1/28 • Number of events 1 • 1 year
|
|
Investigations
GLUCOSE, SERUM-HIGH (HYPERGLYCEMIA)
|
25.0%
7/28 • Number of events 12 • 1 year
|
|
Investigations
GLUCOSE, SERUM-LOW (HYPOGLYCEMIA)
|
3.6%
1/28 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
HAIR LOSS/ALOPECIA (SCALP OR BODY)
|
46.4%
13/28 • Number of events 18 • 1 year
|
|
Ear and labyrinth disorders
HEARING: PATIENTS WITHOUT BASELINE AUDIOGRAM AND NOT ENROLLED IN A MONITORING PROGRAM
|
3.6%
1/28 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
HEARTBURN/DYSPEPSIA
|
42.9%
12/28 • Number of events 18 • 1 year
|
|
Blood and lymphatic system disorders
HEMOGLOBIN
|
67.9%
19/28 • Number of events 40 • 1 year
|
|
Gastrointestinal disorders
HEMORRHAGE, GI / VARICES (RECTAL)
|
3.6%
1/28 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
HEMORRHAGE, PULMONARY/UPPER RESPIRATORY / NOSE
|
14.3%
4/28 • Number of events 5 • 1 year
|
|
General disorders
HEMORRHAGE/BLEEDING - OTHER
|
7.1%
2/28 • Number of events 3 • 1 year
|
|
Gastrointestinal disorders
HEMORRHOIDS
|
3.6%
1/28 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
HICCOUGHS (HICCUPS, SINGULTUS)
|
7.1%
2/28 • Number of events 2 • 1 year
|
|
Endocrine disorders
HOT FLASHES/FLUSHES
|
10.7%
3/28 • Number of events 4 • 1 year
|
|
Skin and subcutaneous tissue disorders
HYPERPIGMENTATION
|
3.6%
1/28 • Number of events 1 • 1 year
|
|
Cardiac disorders
HYPERTENSION
|
7.1%
2/28 • Number of events 2 • 1 year
|
|
Cardiac disorders
HYPOTENSION
|
3.6%
1/28 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
3.6%
1/28 • Number of events 1 • 1 year
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / MUCOSA
|
3.6%
1/28 • Number of events 1 • 1 year
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / PENIS
|
3.6%
1/28 • Number of events 1 • 1 year
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / SINUS
|
7.1%
2/28 • Number of events 2 • 1 year
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / SKIN (CELLULITIS)
|
3.6%
1/28 • Number of events 1 • 1 year
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / UPPER AIRWAY NOS
|
3.6%
1/28 • Number of events 1 • 1 year
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / URINARY TRACT NOS
|
7.1%
2/28 • Number of events 2 • 1 year
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / WOUND
|
3.6%
1/28 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
INJECTION SITE REACTION/EXTRAVASATION CHANGES
|
3.6%
1/28 • Number of events 1 • 1 year
|
|
Surgical and medical procedures
INR (INTERNATIONAL NORMALIZED RATIO OF PROTHROMBIN TIME)
|
3.6%
1/28 • Number of events 1 • 1 year
|
|
General disorders
INSOMNIA
|
42.9%
12/28 • Number of events 18 • 1 year
|
|
Cardiac disorders
LEFT VENTRICULAR DIASTOLIC DYSFUNCTION
|
3.6%
1/28 • Number of events 1 • 1 year
|
|
Blood and lymphatic system disorders
LEUKOCYTES (TOTAL WBC)
|
17.9%
5/28 • Number of events 21 • 1 year
|
|
Investigations
LIPASE
|
3.6%
1/28 • Number of events 1 • 1 year
|
|
Blood and lymphatic system disorders
LYMPHEDEMA-RELATED FIBROSIS
|
3.6%
1/28 • Number of events 1 • 1 year
|
|
Blood and lymphatic system disorders
LYMPHOPENIA
|
3.6%
1/28 • Number of events 2 • 1 year
|
|
Investigations
METABOLIC/LABORATORY - OTHER
|
10.7%
3/28 • Number of events 3 • 1 year
|
|
Psychiatric disorders
MOOD ALTERATION / AGITATION
|
3.6%
1/28 • Number of events 1 • 1 year
|
|
Psychiatric disorders
MOOD ALTERATION / ANXIETY
|
28.6%
8/28 • Number of events 10 • 1 year
|
|
Psychiatric disorders
MOOD ALTERATION / DEPRESSION
|
35.7%
10/28 • Number of events 12 • 1 year
|
|
Surgical and medical procedures
MUCOSITIS/STOMATITIS (CLINICAL EXAM) / ANUS
|
3.6%
1/28 • Number of events 1 • 1 year
|
|
Surgical and medical procedures
MUCOSITIS/STOMATITIS (CLINICAL EXAM) / ORAL CAVITY
|
17.9%
5/28 • Number of events 6 • 1 year
|
|
Gastrointestinal disorders
MUCOSITIS/STOMATITIS (FUNCTIONAL/SYMPTOMATIC) / ESOPHAGUS
|
7.1%
2/28 • Number of events 4 • 1 year
|
|
Gastrointestinal disorders
MUCOSITIS/STOMATITIS (FUNCTIONAL/SYMPTOMATIC) / ORAL CAVITY
|
7.1%
2/28 • Number of events 2 • 1 year
|
|
Eye disorders
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) / EXTRAOCULAR
|
7.1%
2/28 • Number of events 2 • 1 year
|
|
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) / EXTREMITY-LOWER
|
17.9%
5/28 • Number of events 6 • 1 year
|
|
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) / EXTREMITY-UPPER
|
3.6%
1/28 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) / WHOLE BODY/GENERALIZED
|
3.6%
1/28 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
NAIL CHANGES
|
3.6%
1/28 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
NAUSEA
|
57.1%
16/28 • Number of events 24 • 1 year
|
|
Nervous system disorders
NEUROLOGY - OTHER
|
7.1%
2/28 • Number of events 2 • 1 year
|
|
Nervous system disorders
NEUROPATHY: MOTOR
|
3.6%
1/28 • Number of events 1 • 1 year
|
|
Nervous system disorders
NEUROPATHY: SENSORY
|
42.9%
12/28 • Number of events 14 • 1 year
|
|
Blood and lymphatic system disorders
NEUTROPHILS/GRANULOCYTES (ANC/AGC)
|
39.3%
11/28 • Number of events 32 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
OBSTRUCTION/STENOSIS OF AIRWAY / BRONCHUS
|
3.6%
1/28 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
PAIN / ABDOMEN NOS
|
32.1%
9/28 • Number of events 15 • 1 year
|
|
Gastrointestinal disorders
PAIN / ANUS
|
3.6%
1/28 • Number of events 3 • 1 year
|
|
General disorders
PAIN / BACK
|
35.7%
10/28 • Number of events 12 • 1 year
|
|
Musculoskeletal and connective tissue disorders
PAIN / BONE
|
10.7%
3/28 • Number of events 5 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
PAIN / CHEST WALL
|
3.6%
1/28 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
PAIN / CHEST/THORAX NOS
|
17.9%
5/28 • Number of events 5 • 1 year
|
|
Gastrointestinal disorders
PAIN / DENTAL/TEETH/PERIDONTAL
|
3.6%
1/28 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
PAIN / ESOPHAGUS
|
7.1%
2/28 • Number of events 2 • 1 year
|
|
Musculoskeletal and connective tissue disorders
PAIN / EXTREMITY-LIMB
|
17.9%
5/28 • Number of events 8 • 1 year
|
|
General disorders
PAIN / HEAD/HEADACHE
|
17.9%
5/28 • Number of events 5 • 1 year
|
|
General disorders
SWEATING (DIAPHORESIS)
|
7.1%
2/28 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
TASTE ALTERATION (DYSGEUSIA)
|
17.9%
5/28 • Number of events 8 • 1 year
|
|
Endocrine disorders
THYROID FUNCTION, HIGH (HYPERTHYROIDISM, THYROTOXICOSIS)
|
3.6%
1/28 • Number of events 1 • 1 year
|
|
Eye disorders
VISION-BLURRED VISION
|
10.7%
3/28 • Number of events 3 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
VOICE CHANGES/DYSARTHRIA (E.G., HOARSENESS, LOSS OR ALTERATION IN VOICE, LARYNGITIS)
|
7.1%
2/28 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
VOMITING
|
28.6%
8/28 • Number of events 12 • 1 year
|
|
Eye disorders
WATERY EYE (EPIPHORA, TEARING)
|
7.1%
2/28 • Number of events 2 • 1 year
|
|
General disorders
WEIGHT LOSS
|
17.9%
5/28 • Number of events 5 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place