Trial Outcomes & Findings for Capecitabine and Lapatinib Ditosylate With or Without Cixutumumab in Treating Patients With Previously Treated HER2-Positive Stage IIIB-IV Breast Cancer (NCT NCT00684983)
NCT ID: NCT00684983
Last Updated: 2020-03-24
Results Overview
Analysis of the primary endpoint, PFS, will be performed using Cox regression with treatment group as a single covariate.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
64 participants
Primary outcome timeframe
From randomization to the earliest date of documentation of disease progression, up to 5 years
Results posted on
2020-03-24
Participant Flow
Total of 68 (Arm A:20, B: 48) patients were accrued, 8 safety cohort patients from arm B are not eligible for primary end point analysis. There were 3 cancels (Arm B), 1 ineligible (arm A) and 1 major violation (Arm B, this patient is included in the primary analysis per protocol). Total of 64 patients started and completed the treatment.
Participant milestones
| Measure |
Arm A
Patients receive oral capecitabine twice daily on days 1-14 and oral lapatinib ditosylate once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. lapatinib ditosylate: Given PO and capecitabine: Given PO
|
Arm B
Patients receive capecitabine and lapatinib ditosylate as in arm I. Patients also receive cixutumumab IV over 1-1½ hours on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV, lapatinib ditosylate: Given PO and capecitabine: Given PO
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
45
|
|
Overall Study
COMPLETED
|
19
|
45
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Capecitabine and Lapatinib Ditosylate With or Without Cixutumumab in Treating Patients With Previously Treated HER2-Positive Stage IIIB-IV Breast Cancer
Baseline characteristics by cohort
| Measure |
Arm A
n=19 Participants
Patients receive oral capecitabine twice daily on days 1-14 and oral lapatinib ditosylate once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. lapatinib ditosylate: Given PO and capecitabine: Given PO
|
Arm B
n=45 Participants
Patients receive capecitabine and lapatinib ditosylate as in arm I. Patients also receive cixutumumab IV over 1-1½ hours on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV, lapatinib ditosylate: Given PO and capecitabine: Given PO
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57 years
n=5 Participants
|
53 years
n=7 Participants
|
53.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=5 Participants
|
45 participants
n=7 Participants
|
64 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From randomization to the earliest date of documentation of disease progression, up to 5 yearsPopulation: First 8 patients in Arm B are from safety cohort, they are not eligible for primary end point
Analysis of the primary endpoint, PFS, will be performed using Cox regression with treatment group as a single covariate.
Outcome measures
| Measure |
Arm A
n=19 Participants
Patients receive oral capecitabine twice daily on days 1-14 and oral lapatinib ditosylate once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. lapatinib ditosylate: Given PO and capecitabine: Given PO
|
Arm B
n=37 Participants
Patients receive capecitabine and lapatinib ditosylate as in arm I. Patients also receive cixutumumab IV over 1-1½ hours on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV, lapatinib ditosylate: Given PO and capecitabine: Given PO
|
|---|---|---|
|
Progression-free Survival (PFS)
|
6.0 Median survival and CI in months
Interval 4.3 to 8.6
|
4.9 Median survival and CI in months
Interval 2.9 to 8.5
|
SECONDARY outcome
Timeframe: From randomization to death due to any cause, up to 5 yearsPopulation: All evaluable patients
Median Survival time (months)
Outcome measures
| Measure |
Arm A
n=19 Participants
Patients receive oral capecitabine twice daily on days 1-14 and oral lapatinib ditosylate once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. lapatinib ditosylate: Given PO and capecitabine: Given PO
|
Arm B
n=37 Participants
Patients receive capecitabine and lapatinib ditosylate as in arm I. Patients also receive cixutumumab IV over 1-1½ hours on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV, lapatinib ditosylate: Given PO and capecitabine: Given PO
|
|---|---|---|
|
Overall Survival
|
16.8 Months
Interval 1.7 to 37.9
|
14.7 Months
Interval 3.1 to 47.7
|
SECONDARY outcome
Timeframe: From the date of randomization to the date at which the patient is removed from treatment due to progression, adverse events, or refusal, up to 5 yearsDistribution estimated by the Kaplan-Meier (1958) method for each treatment arm.
Outcome measures
| Measure |
Arm A
n=19 Participants
Patients receive oral capecitabine twice daily on days 1-14 and oral lapatinib ditosylate once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. lapatinib ditosylate: Given PO and capecitabine: Given PO
|
Arm B
n=37 Participants
Patients receive capecitabine and lapatinib ditosylate as in arm I. Patients also receive cixutumumab IV over 1-1½ hours on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV, lapatinib ditosylate: Given PO and capecitabine: Given PO
|
|---|---|---|
|
Time to Treatment Failure
|
4.6 Months
Interval 0.4 to 12.0
|
4.4 Months
Interval 0.8 to 24.0
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Includes patients with at least one disease assessment at least 6 weeks after registration.
Outcome measures
| Measure |
Arm A
n=16 Participants
Patients receive oral capecitabine twice daily on days 1-14 and oral lapatinib ditosylate once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. lapatinib ditosylate: Given PO and capecitabine: Given PO
|
Arm B
n=31 Participants
Patients receive capecitabine and lapatinib ditosylate as in arm I. Patients also receive cixutumumab IV over 1-1½ hours on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV, lapatinib ditosylate: Given PO and capecitabine: Given PO
|
|---|---|---|
|
Confirmed Tumor Response, Defined as Either a Complete Response (CR) or Partial Response (PR) Noted as the Objective Status on 2 Consecutive Evaluations at Least 6 Weeks Apart, Assessed by Response Evaluation Criteria for Solid Tumors (RECIST)
|
43.8 % of evaluable participants
Interval 19.8 to 70.1
|
29 % of evaluable participants
Interval 14.2 to 48.0
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Evaluable patients that had a response to treatment drug
Distribution estimated by the Kaplan-Meier (1958) method for each treatment arm.
Outcome measures
| Measure |
Arm A
n=7 Participants
Patients receive oral capecitabine twice daily on days 1-14 and oral lapatinib ditosylate once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. lapatinib ditosylate: Given PO and capecitabine: Given PO
|
Arm B
n=9 Participants
Patients receive capecitabine and lapatinib ditosylate as in arm I. Patients also receive cixutumumab IV over 1-1½ hours on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV, lapatinib ditosylate: Given PO and capecitabine: Given PO
|
|---|---|---|
|
Duration of Response
|
4.8 Months
Interval 3.2 to 8.6
|
6.9 Months
Interval 3.0 to 21.8
|
SECONDARY outcome
Timeframe: Baseline to 30 days past end of treatmentAll eligible patients that have initiated treatment will be considered evaluable for assessing adverse event rate(s) according to CTCAE v3.0 within each treatment arm. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. 4/19 (21.05%) 14/45 (31.11%)
Outcome measures
| Measure |
Arm A
n=19 Participants
Patients receive oral capecitabine twice daily on days 1-14 and oral lapatinib ditosylate once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. lapatinib ditosylate: Given PO and capecitabine: Given PO
|
Arm B
n=45 Participants
Patients receive capecitabine and lapatinib ditosylate as in arm I. Patients also receive cixutumumab IV over 1-1½ hours on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV, lapatinib ditosylate: Given PO and capecitabine: Given PO
|
|---|---|---|
|
Adverse Event Profile of Capecitabine and Lapatinib With and Without IMC-A12 (Using NCI CTCAE v3.0)
|
21 percentage of patients with AEs
|
31 percentage of patients with AEs
|
Adverse Events
Arm A
Serious events: 4 serious events
Other events: 19 other events
Deaths: 0 deaths
Arm B
Serious events: 14 serious events
Other events: 43 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A
n=19 participants at risk
Patients receive oral capecitabine twice daily on days 1-14 and oral lapatinib ditosylate once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. lapatinib ditosylate: Given PO and capecitabine: Given PO
|
Arm B
n=45 participants at risk
Patients receive capecitabine and lapatinib ditosylate as in arm I. Patients also receive cixutumumab IV over 1-1½ hours on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV, lapatinib ditosylate: Given PO and capecitabine: Given PO
|
|---|---|---|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
0.00%
0/19
|
2.2%
1/45 • Number of events 1
|
|
Blood and lymphatic system disorders
Hemolysis
|
0.00%
0/19
|
2.2%
1/45 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
10.5%
2/19 • Number of events 2
|
2.2%
1/45 • Number of events 2
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
0.00%
0/19
|
2.2%
1/45 • Number of events 1
|
|
Gastrointestinal disorders
Esophageal ulcer
|
0.00%
0/19
|
2.2%
1/45 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis
|
5.3%
1/19 • Number of events 1
|
2.2%
1/45 • Number of events 1
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/19
|
2.2%
1/45 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
5.3%
1/19 • Number of events 1
|
2.2%
1/45 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
5.3%
1/19 • Number of events 1
|
2.2%
1/45 • Number of events 1
|
|
General disorders
Chest pain
|
0.00%
0/19
|
2.2%
1/45 • Number of events 1
|
|
General disorders
Chills
|
0.00%
0/19
|
2.2%
1/45 • Number of events 1
|
|
General disorders
Disease progression
|
5.3%
1/19 • Number of events 1
|
0.00%
0/45
|
|
General disorders
Fatigue
|
0.00%
0/19
|
2.2%
1/45 • Number of events 1
|
|
General disorders
Fever
|
0.00%
0/19
|
2.2%
1/45 • Number of events 1
|
|
General disorders
Pain
|
0.00%
0/19
|
2.2%
1/45 • Number of events 1
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/19
|
2.2%
1/45 • Number of events 1
|
|
Infections and infestations
Lip infection
|
0.00%
0/19
|
2.2%
1/45 • Number of events 1
|
|
Infections and infestations
Nail infection
|
0.00%
0/19
|
2.2%
1/45 • Number of events 1
|
|
Infections and infestations
Skin infection
|
5.3%
1/19 • Number of events 1
|
0.00%
0/45
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/19
|
2.2%
1/45 • Number of events 1
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/19
|
2.2%
1/45 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
5.3%
1/19 • Number of events 1
|
0.00%
0/45
|
|
Investigations
Alanine aminotransferase increased
|
5.3%
1/19 • Number of events 1
|
0.00%
0/45
|
|
Investigations
Aspartate aminotransferase increased
|
5.3%
1/19 • Number of events 1
|
0.00%
0/45
|
|
Investigations
Creatinine increased
|
0.00%
0/19
|
4.4%
2/45 • Number of events 2
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/19
|
2.2%
1/45 • Number of events 1
|
|
Investigations
Platelet count decreased
|
0.00%
0/19
|
2.2%
1/45 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
5.3%
1/19 • Number of events 1
|
2.2%
1/45 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
0.00%
0/19
|
2.2%
1/45 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
0.00%
0/19
|
4.4%
2/45 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
0.00%
0/19
|
2.2%
1/45 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/19
|
2.2%
1/45 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/19
|
2.2%
1/45 • Number of events 1
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.00%
0/19
|
2.2%
1/45 • Number of events 1
|
|
Nervous system disorders
Headache
|
0.00%
0/19
|
2.2%
1/45 • Number of events 1
|
|
Nervous system disorders
Seizure
|
5.3%
1/19 • Number of events 1
|
0.00%
0/45
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/19
|
2.2%
1/45 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/19
|
2.2%
1/45 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/19
|
2.2%
1/45 • Number of events 1
|
|
Vascular disorders
Hypotension
|
0.00%
0/19
|
2.2%
1/45 • Number of events 1
|
|
Vascular disorders
Thrombosis
|
0.00%
0/19
|
2.2%
1/45 • Number of events 1
|
Other adverse events
| Measure |
Arm A
n=19 participants at risk
Patients receive oral capecitabine twice daily on days 1-14 and oral lapatinib ditosylate once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. lapatinib ditosylate: Given PO and capecitabine: Given PO
|
Arm B
n=45 participants at risk
Patients receive capecitabine and lapatinib ditosylate as in arm I. Patients also receive cixutumumab IV over 1-1½ hours on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV, lapatinib ditosylate: Given PO and capecitabine: Given PO
|
|---|---|---|
|
General disorders
Chills
|
5.3%
1/19 • Number of events 2
|
2.2%
1/45 • Number of events 1
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
57.9%
11/19 • Number of events 57
|
57.8%
26/45 • Number of events 137
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/19
|
2.2%
1/45 • Number of events 1
|
|
Cardiac disorders
Left ventricular failure
|
5.3%
1/19 • Number of events 1
|
2.2%
1/45 • Number of events 3
|
|
Cardiac disorders
Palpitations
|
0.00%
0/19
|
2.2%
1/45 • Number of events 1
|
|
Cardiac disorders
Ventricular bigeminy
|
0.00%
0/19
|
2.2%
1/45 • Number of events 1
|
|
Eye disorders
Dry eye syndrome
|
0.00%
0/19
|
4.4%
2/45 • Number of events 2
|
|
Eye disorders
Flashing vision
|
0.00%
0/19
|
8.9%
4/45 • Number of events 12
|
|
Eye disorders
Vision blurred
|
5.3%
1/19 • Number of events 2
|
11.1%
5/45 • Number of events 6
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/19
|
6.7%
3/45 • Number of events 3
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/19
|
2.2%
1/45 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
10.5%
2/19 • Number of events 2
|
17.8%
8/45 • Number of events 26
|
|
Gastrointestinal disorders
Diarrhea
|
84.2%
16/19 • Number of events 46
|
77.8%
35/45 • Number of events 133
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/19
|
6.7%
3/45 • Number of events 17
|
|
Gastrointestinal disorders
Dyspepsia
|
5.3%
1/19 • Number of events 1
|
8.9%
4/45 • Number of events 8
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/19
|
4.4%
2/45 • Number of events 2
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
52.6%
10/19 • Number of events 20
|
46.7%
21/45 • Number of events 49
|
|
Gastrointestinal disorders
Esophageal pain
|
0.00%
0/19
|
2.2%
1/45 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/19
|
2.2%
1/45 • Number of events 1
|
|
Gastrointestinal disorders
Mucositis oral
|
52.6%
10/19 • Number of events 14
|
48.9%
22/45 • Number of events 35
|
|
Gastrointestinal disorders
Nausea
|
47.4%
9/19 • Number of events 11
|
48.9%
22/45 • Number of events 63
|
|
Gastrointestinal disorders
Proctoscopy abnormal
|
0.00%
0/19
|
2.2%
1/45 • Number of events 1
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/19
|
2.2%
1/45 • Number of events 1
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/19
|
2.2%
1/45 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
15.8%
3/19 • Number of events 4
|
20.0%
9/45 • Number of events 16
|
|
General disorders
Chest pain
|
5.3%
1/19 • Number of events 1
|
0.00%
0/45
|
|
General disorders
Fatigue
|
89.5%
17/19 • Number of events 83
|
82.2%
37/45 • Number of events 175
|
|
General disorders
Fever
|
0.00%
0/19
|
2.2%
1/45 • Number of events 1
|
|
General disorders
Localized edema
|
0.00%
0/19
|
2.2%
1/45 • Number of events 1
|
|
General disorders
Pain
|
5.3%
1/19 • Number of events 1
|
6.7%
3/45 • Number of events 5
|
|
General disorders
Pericardial pain
|
0.00%
0/19
|
2.2%
1/45 • Number of events 1
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/19
|
2.2%
1/45 • Number of events 1
|
|
Immune system disorders
Hypersensitivity
|
10.5%
2/19 • Number of events 2
|
2.2%
1/45 • Number of events 3
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/19
|
2.2%
1/45 • Number of events 2
|
|
Infections and infestations
Infection
|
0.00%
0/19
|
2.2%
1/45 • Number of events 15
|
|
Infections and infestations
Nail infection
|
0.00%
0/19
|
6.7%
3/45 • Number of events 12
|
|
Infections and infestations
Skin infection
|
0.00%
0/19
|
4.4%
2/45 • Number of events 2
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/19
|
2.2%
1/45 • Number of events 1
|
|
Infections and infestations
Wound infection
|
5.3%
1/19 • Number of events 1
|
0.00%
0/45
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/19
|
2.2%
1/45 • Number of events 1
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/19
|
2.2%
1/45 • Number of events 1
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/19
|
2.2%
1/45 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
21.1%
4/19 • Number of events 8
|
22.2%
10/45 • Number of events 26
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/19
|
11.1%
5/45 • Number of events 7
|
|
Investigations
Amylase increased
|
10.5%
2/19 • Number of events 3
|
6.7%
3/45 • Number of events 3
|
|
Investigations
Aspartate aminotransferase increased
|
47.4%
9/19 • Number of events 22
|
24.4%
11/45 • Number of events 21
|
|
Investigations
Bilirubin increased
|
26.3%
5/19 • Number of events 12
|
13.3%
6/45 • Number of events 20
|
|
Investigations
Coagulopathy
|
0.00%
0/19
|
2.2%
1/45 • Number of events 1
|
|
Investigations
Creatinine increased
|
5.3%
1/19 • Number of events 1
|
11.1%
5/45 • Number of events 19
|
|
Investigations
INR increased
|
0.00%
0/19
|
2.2%
1/45 • Number of events 1
|
|
Investigations
Laboratory test abnormal
|
0.00%
0/19
|
2.2%
1/45 • Number of events 6
|
|
Investigations
Leukocyte count decreased
|
15.8%
3/19 • Number of events 3
|
13.3%
6/45 • Number of events 12
|
|
Investigations
Lipase increased
|
10.5%
2/19 • Number of events 2
|
8.9%
4/45 • Number of events 4
|
|
Investigations
Lymphocyte count decreased
|
5.3%
1/19 • Number of events 1
|
6.7%
3/45 • Number of events 7
|
|
Investigations
Neutrophil count decreased
|
31.6%
6/19 • Number of events 19
|
20.0%
9/45 • Number of events 29
|
|
Investigations
Platelet count decreased
|
10.5%
2/19 • Number of events 2
|
22.2%
10/45 • Number of events 31
|
|
Investigations
Serum cholesterol increased
|
5.3%
1/19 • Number of events 1
|
6.7%
3/45 • Number of events 8
|
|
Investigations
Weight loss
|
5.3%
1/19 • Number of events 1
|
24.4%
11/45 • Number of events 45
|
|
Metabolism and nutrition disorders
Anorexia
|
10.5%
2/19 • Number of events 4
|
33.3%
15/45 • Number of events 46
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
47.4%
9/19 • Number of events 18
|
64.4%
29/45 • Number of events 131
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/19
|
6.7%
3/45 • Number of events 4
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
10.5%
2/19 • Number of events 3
|
8.9%
4/45 • Number of events 21
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.00%
0/19
|
2.2%
1/45 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/19
|
2.2%
1/45 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
10.5%
2/19 • Number of events 2
|
2.2%
1/45 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
0.00%
0/19
|
8.9%
4/45 • Number of events 7
|
|
Metabolism and nutrition disorders
Serum calcium increased
|
0.00%
0/19
|
2.2%
1/45 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum magnesium decreased
|
0.00%
0/19
|
15.6%
7/45 • Number of events 10
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
0.00%
0/19
|
2.2%
1/45 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
5.3%
1/19 • Number of events 2
|
11.1%
5/45 • Number of events 13
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
0.00%
0/19
|
2.2%
1/45 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
0.00%
0/19
|
4.4%
2/45 • Number of events 8
|
|
Metabolism and nutrition disorders
Serum triglycerides increased
|
0.00%
0/19
|
8.9%
4/45 • Number of events 14
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/19
|
4.4%
2/45 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.3%
1/19 • Number of events 1
|
0.00%
0/45
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/19
|
4.4%
2/45 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
0.00%
0/19
|
2.2%
1/45 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/19
|
8.9%
4/45 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/19
|
2.2%
1/45 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/19
|
6.7%
3/45 • Number of events 6
|
|
Nervous system disorders
Ataxia
|
0.00%
0/19
|
2.2%
1/45 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
10.5%
2/19 • Number of events 2
|
4.4%
2/45 • Number of events 3
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.00%
0/19
|
2.2%
1/45 • Number of events 1
|
|
Nervous system disorders
Headache
|
0.00%
0/19
|
6.7%
3/45 • Number of events 10
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/19
|
2.2%
1/45 • Number of events 1
|
|
Nervous system disorders
Peripheral motor neuropathy
|
10.5%
2/19 • Number of events 6
|
0.00%
0/45
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
21.1%
4/19 • Number of events 14
|
15.6%
7/45 • Number of events 13
|
|
Nervous system disorders
Seizure
|
0.00%
0/19
|
2.2%
1/45 • Number of events 1
|
|
Nervous system disorders
Taste alteration
|
0.00%
0/19
|
24.4%
11/45 • Number of events 27
|
|
Nervous system disorders
Tremor
|
0.00%
0/19
|
2.2%
1/45 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/19
|
2.2%
1/45 • Number of events 1
|
|
Psychiatric disorders
Confusion
|
0.00%
0/19
|
2.2%
1/45 • Number of events 1
|
|
Psychiatric disorders
Depression
|
0.00%
0/19
|
4.4%
2/45 • Number of events 3
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/19
|
11.1%
5/45 • Number of events 11
|
|
Renal and urinary disorders
Hemorrhage urinary tract
|
0.00%
0/19
|
2.2%
1/45 • Number of events 1
|
|
Renal and urinary disorders
Protein urine positive
|
0.00%
0/19
|
4.4%
2/45 • Number of events 2
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/19
|
2.2%
1/45 • Number of events 1
|
|
Reproductive system and breast disorders
Vaginal dryness
|
0.00%
0/19
|
2.2%
1/45 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/19
|
4.4%
2/45 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.3%
1/19 • Number of events 1
|
4.4%
2/45 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.3%
1/19 • Number of events 1
|
11.1%
5/45 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage nasal
|
0.00%
0/19
|
15.6%
7/45 • Number of events 14
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal examination abnormal
|
5.3%
1/19 • Number of events 1
|
11.1%
5/45 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
5.3%
1/19 • Number of events 1
|
11.1%
5/45 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/19
|
2.2%
1/45 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/19
|
2.2%
1/45 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/19
|
6.7%
3/45 • Number of events 7
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
21.1%
4/19 • Number of events 7
|
13.3%
6/45 • Number of events 11
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/19
|
2.2%
1/45 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hand-and-foot syndrome
|
73.7%
14/19 • Number of events 52
|
62.2%
28/45 • Number of events 118
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/19
|
15.6%
7/45 • Number of events 28
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
26.3%
5/19 • Number of events 7
|
20.0%
9/45 • Number of events 24
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
10.5%
2/19 • Number of events 2
|
4.4%
2/45 • Number of events 10
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
47.4%
9/19 • Number of events 20
|
46.7%
21/45 • Number of events 52
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/19
|
4.4%
2/45 • Number of events 7
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/19
|
2.2%
1/45 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
10.5%
2/19 • Number of events 2
|
2.2%
1/45 • Number of events 4
|
|
Vascular disorders
Hot flashes
|
0.00%
0/19
|
2.2%
1/45 • Number of events 1
|
|
Vascular disorders
Hypertension
|
0.00%
0/19
|
2.2%
1/45 • Number of events 1
|
|
Vascular disorders
Hypotension
|
0.00%
0/19
|
2.2%
1/45 • Number of events 1
|
|
Vascular disorders
Lymphedema
|
5.3%
1/19 • Number of events 1
|
0.00%
0/45
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60