Trial Outcomes & Findings for Sorafenib Tosylate in Treating Patients With Progressive Metastatic Neuroendocrine Tumors (NCT NCT00131911)
NCT ID: NCT00131911
Last Updated: 2014-11-17
Results Overview
Confirmed response rate was defined using Response Evaluation Criteria In Solid Tumors (RECIST). A confirmed response is defined as a complete response (CR) or partial response (PR) observed on subsequent scans at least 4 weeks apart. Confirmed response rate was estimated by the number of successes divided by the total number of evaluable patients.\> \> Complete Response (CR) is defined as the disappearance of all target lesions.\> Partial Response (PR) is defined as a 30% decrease in sum of longest diameter of target lesions;\> \> We report the percentage of patients with a confirmed response and a 95% confidence interval estimated by the Duffy and Santner method.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
93 participants
Primary outcome timeframe
Duration of Treatment (Up to 2 years)
Results posted on
2014-11-17
Participant Flow
Between June 21, 2005 and September 15, 2006, a total of 93 (51 carcinoid, 42 islet cell) patients initiated treatment on this study.
One carcinoid patient canceled prior to treatment and was excluded from all analyses.
Participant milestones
| Measure |
Group A (Patients With Carcinoid Tumors)
Patients receive 400 mg oral sorafenib twice daily on days 1-28.
|
Group B (Islet Cell and Other Neuroendocrine Tumors)
Patients receive 400 mg oral sorafenib twice daily on days 1-28.
|
|---|---|---|
|
Overall Study
STARTED
|
51
|
42
|
|
Overall Study
COMPLETED
|
50
|
42
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Group A (Patients With Carcinoid Tumors)
Patients receive 400 mg oral sorafenib twice daily on days 1-28.
|
Group B (Islet Cell and Other Neuroendocrine Tumors)
Patients receive 400 mg oral sorafenib twice daily on days 1-28.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Sorafenib Tosylate in Treating Patients With Progressive Metastatic Neuroendocrine Tumors
Baseline characteristics by cohort
| Measure |
Group A (Patients With Carcinoid Tumors)
n=51 Participants
Patients receive 400 mg oral sorafenib twice daily on days 1-28.
|
Group B (Islet Cell and Other Neuroendocrine Tumors)
n=42 Participants
Patients receive 400 mg oral sorafenib twice daily on days 1-28.
|
Total
n=93 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60 years
n=5 Participants
|
56.5 years
n=7 Participants
|
59 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
51 participants
n=5 Participants
|
42 participants
n=7 Participants
|
93 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Duration of Treatment (Up to 2 years)Population: Nine of the 50 carcinoid patients and 6 of the 42 Islet cell patients did not continue treatment past cycle 1. Therefore, these patients were not evaluated on consecutive cycles and were excluded from this endpoint.
Confirmed response rate was defined using Response Evaluation Criteria In Solid Tumors (RECIST). A confirmed response is defined as a complete response (CR) or partial response (PR) observed on subsequent scans at least 4 weeks apart. Confirmed response rate was estimated by the number of successes divided by the total number of evaluable patients.\> \> Complete Response (CR) is defined as the disappearance of all target lesions.\> Partial Response (PR) is defined as a 30% decrease in sum of longest diameter of target lesions;\> \> We report the percentage of patients with a confirmed response and a 95% confidence interval estimated by the Duffy and Santner method.
Outcome measures
| Measure |
Group A (Patients With Carcinoid Tumors)
n=41 Participants
Patients receive 400 mg oral sorafenib twice daily on days 1-28.
|
Group B (Islet Cell and Other Neuroendocrine Tumors)
n=36 Participants
Patients receive 400 mg oral sorafenib twice daily on days 1-28.
|
|---|---|---|
|
Confirmed Response Rate
|
10 percentage of participants
Interval 3.0 to 24.0
|
14 percentage of participants
Interval 6.0 to 32.0
|
SECONDARY outcome
Timeframe: Up to 2 yearsFor this secondary endpoint, toxicity is defined as a grade 3 or higher adverse events that is classified as either possibly, probably, or definitely related to study treatment. The assignment of attribution to study treatment and grade (or degree of severity) of the adverse event are classified using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The number of participants reporting a grade 3 or higher toxicity are reported.
Outcome measures
| Measure |
Group A (Patients With Carcinoid Tumors)
n=50 Participants
Patients receive 400 mg oral sorafenib twice daily on days 1-28.
|
Group B (Islet Cell and Other Neuroendocrine Tumors)
n=42 Participants
Patients receive 400 mg oral sorafenib twice daily on days 1-28.
|
|---|---|---|
|
Toxicity
Grade 3 Toxicity
|
37 participants
|
25 participants
|
|
Toxicity
Grade 4 or Grade 5 Toxicity
|
5 participants
|
2 participants
|
SECONDARY outcome
Timeframe: From registration to death (up to 2 years)Overall survival (OS) was defined as the time from registration to death of any cause. Surviving patients were censored at the date of last follow-up. The median OS with 95% CI was estimated using the Kaplan Meier method.
Outcome measures
| Measure |
Group A (Patients With Carcinoid Tumors)
n=50 Participants
Patients receive 400 mg oral sorafenib twice daily on days 1-28.
|
Group B (Islet Cell and Other Neuroendocrine Tumors)
n=42 Participants
Patients receive 400 mg oral sorafenib twice daily on days 1-28.
|
|---|---|---|
|
Overall Survival
|
25.6 months
Interval 15.5 to 30.2
|
NA months
At the time of analysis, a sufficient number of events had not been recorded to estimate.
|
SECONDARY outcome
Timeframe: Time from registration to progression or death (up to 2 years)Progression was defined using Response Evaluation Criteria In Solid Tumors (RECIST) as a 20% increase in the su of longest diameter of target lesions. Progression free survival (PFS) was defined as the time from registration to progression or death of any cause. Participants who were progression free were censored at the date of their most recent disease assessment. The median PFS with 95% CI was estimated using the Kaplan Meier method.
Outcome measures
| Measure |
Group A (Patients With Carcinoid Tumors)
n=50 Participants
Patients receive 400 mg oral sorafenib twice daily on days 1-28.
|
Group B (Islet Cell and Other Neuroendocrine Tumors)
n=42 Participants
Patients receive 400 mg oral sorafenib twice daily on days 1-28.
|
|---|---|---|
|
Progression Free Survival
|
9.1 months
Interval 5.7 to 12.7
|
12.7 months
Interval 8.3 to 19.9
|
SECONDARY outcome
Timeframe: Time from response to progression (up to 2 years)Population: There were 4 confirmed responses in Group A and 5 confirmed responses in Group B used in analyzing this endpoint.
Duration of response (DOR) was defined as the time from attaining a response (PR or CR) to the date of progression. Participants without progression were censored at the date of their most recent disease assessment. The median DOR was estimated using simple summary statistics.
Outcome measures
| Measure |
Group A (Patients With Carcinoid Tumors)
n=4 Participants
Patients receive 400 mg oral sorafenib twice daily on days 1-28.
|
Group B (Islet Cell and Other Neuroendocrine Tumors)
n=5 Participants
Patients receive 400 mg oral sorafenib twice daily on days 1-28.
|
|---|---|---|
|
Duration of Response
|
6.7 months
Interval 3.7 to 9.2
|
9.2 months
Interval 3.7 to 32.0
|
Adverse Events
All Patients
Serious events: 52 serious events
Other events: 90 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
All Patients
n=93 participants at risk
Patients receive 400 mg oral sorafenib twice daily on days 1-28.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.2%
2/93 • Number of events 2
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
3.2%
3/93 • Number of events 3
|
|
Endocrine disorders
Hypothyroidism
|
1.1%
1/93 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal distension
|
1.1%
1/93 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
19.4%
18/93 • Number of events 22
|
|
Gastrointestinal disorders
Ascites
|
3.2%
3/93 • Number of events 3
|
|
Gastrointestinal disorders
Constipation
|
3.2%
3/93 • Number of events 3
|
|
Gastrointestinal disorders
Diarrhea
|
5.4%
5/93 • Number of events 5
|
|
Gastrointestinal disorders
Dry mouth
|
1.1%
1/93 • Number of events 1
|
|
Gastrointestinal disorders
Duodenal hemorrhage
|
1.1%
1/93 • Number of events 1
|
|
Gastrointestinal disorders
Duodenal perforation
|
1.1%
1/93 • Number of events 1
|
|
Gastrointestinal disorders
Duodenal ulcer
|
1.1%
1/93 • Number of events 1
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
4.3%
4/93 • Number of events 4
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
2.2%
2/93 • Number of events 2
|
|
Gastrointestinal disorders
Intra-abdominal hemorrhage
|
1.1%
1/93 • Number of events 1
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
1.1%
1/93 • Number of events 1
|
|
Gastrointestinal disorders
Mucositis oral
|
1.1%
1/93 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
14.0%
13/93 • Number of events 15
|
|
Gastrointestinal disorders
Rectal fistula
|
1.1%
1/93 • Number of events 1
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
3.2%
3/93 • Number of events 5
|
|
Gastrointestinal disorders
Small intestinal perforation
|
1.1%
1/93 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
8.6%
8/93 • Number of events 9
|
|
General disorders
Chills
|
1.1%
1/93 • Number of events 1
|
|
General disorders
Disease progression
|
1.1%
1/93 • Number of events 1
|
|
General disorders
Edema limbs
|
3.2%
3/93 • Number of events 3
|
|
General disorders
Fatigue
|
16.1%
15/93 • Number of events 15
|
|
General disorders
Fever
|
4.3%
4/93 • Number of events 4
|
|
General disorders
Localized edema
|
1.1%
1/93 • Number of events 1
|
|
Hepatobiliary disorders
Cholecystitis
|
1.1%
1/93 • Number of events 1
|
|
Hepatobiliary disorders
Gallbladder pain
|
1.1%
1/93 • Number of events 1
|
|
Hepatobiliary disorders
Hepatobiliary disease
|
1.1%
1/93 • Number of events 1
|
|
Immune system disorders
Hypersensitivity
|
1.1%
1/93 • Number of events 1
|
|
Infections and infestations
Bladder infection
|
1.1%
1/93 • Number of events 1
|
|
Infections and infestations
Pleural infection
|
1.1%
1/93 • Number of events 3
|
|
Infections and infestations
Pneumonia
|
1.1%
1/93 • Number of events 1
|
|
Infections and infestations
Sepsis
|
1.1%
1/93 • Number of events 1
|
|
Infections and infestations
Skin infection
|
1.1%
1/93 • Number of events 4
|
|
Investigations
Alanine aminotransferase increased
|
1.1%
1/93 • Number of events 1
|
|
Investigations
Alkaline phosphatase increased
|
3.2%
3/93 • Number of events 3
|
|
Investigations
Aspartate aminotransferase increased
|
4.3%
4/93 • Number of events 4
|
|
Investigations
Blood bilirubin increased
|
2.2%
2/93 • Number of events 2
|
|
Investigations
Creatinine increased
|
1.1%
1/93 • Number of events 1
|
|
Investigations
Leukocyte count decreased
|
1.1%
1/93 • Number of events 1
|
|
Investigations
Lymphocyte count decreased
|
1.1%
1/93 • Number of events 1
|
|
Investigations
Neutrophil count decreased
|
1.1%
1/93 • Number of events 1
|
|
Investigations
Weight gain
|
1.1%
1/93 • Number of events 1
|
|
Investigations
Weight loss
|
1.1%
1/93 • Number of events 1
|
|
Metabolism and nutrition disorders
Alkalosis
|
1.1%
1/93 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia
|
10.8%
10/93 • Number of events 11
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
2.2%
2/93 • Number of events 2
|
|
Metabolism and nutrition disorders
Dehydration
|
6.5%
6/93 • Number of events 7
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
3.2%
3/93 • Number of events 3
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
2.2%
2/93 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
1.1%
1/93 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
3.2%
3/93 • Number of events 3
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
3.2%
3/93 • Number of events 3
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
3.2%
3/93 • Number of events 6
|
|
Metabolism and nutrition disorders
Serum sodium increased
|
1.1%
1/93 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum triglycerides increased
|
1.1%
1/93 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.2%
3/93 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.1%
1/93 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.5%
6/93 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.1%
1/93 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.1%
1/93 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
2.2%
2/93 • Number of events 2
|
|
Nervous system disorders
Headache
|
2.2%
2/93 • Number of events 2
|
|
Psychiatric disorders
Confusion
|
1.1%
1/93 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
1.1%
1/93 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.5%
6/93 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.1%
1/93 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract hemorrhage
|
1.1%
1/93 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
2.2%
2/93 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.2%
2/93 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Hand-and-foot syndrome
|
4.3%
4/93 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
4.3%
4/93 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
2.2%
2/93 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
1.1%
1/93 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
1.1%
1/93 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Sweating
|
3.2%
3/93 • Number of events 3
|
|
Vascular disorders
Flushing
|
1.1%
1/93 • Number of events 1
|
|
Vascular disorders
Hemorrhage
|
1.1%
1/93 • Number of events 1
|
|
Vascular disorders
Hot flashes
|
1.1%
1/93 • Number of events 1
|
|
Vascular disorders
Hypotension
|
2.2%
2/93 • Number of events 2
|
|
Vascular disorders
Thrombosis
|
2.2%
2/93 • Number of events 2
|
Other adverse events
| Measure |
All Patients
n=93 participants at risk
Patients receive 400 mg oral sorafenib twice daily on days 1-28.
|
|---|---|
|
Blood and lymphatic system disorders
Blood disorder
|
2.2%
2/93 • Number of events 7
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
19.4%
18/93 • Number of events 63
|
|
Cardiac disorders
Atrial fibrillation
|
2.2%
2/93 • Number of events 2
|
|
Cardiac disorders
Atrial flutter
|
1.1%
1/93 • Number of events 1
|
|
Cardiac disorders
Cardiac disorder
|
1.1%
1/93 • Number of events 1
|
|
Cardiac disorders
Sinus bradycardia
|
1.1%
1/93 • Number of events 1
|
|
Ear and labyrinth disorders
Hearing test abnormal
|
1.1%
1/93 • Number of events 3
|
|
Endocrine disorders
Hypothyroidism
|
1.1%
1/93 • Number of events 37
|
|
Eye disorders
Diplopia
|
1.1%
1/93 • Number of events 1
|
|
Eye disorders
Eye disorder
|
1.1%
1/93 • Number of events 2
|
|
Eye disorders
Retinal detachment
|
1.1%
1/93 • Number of events 1
|
|
Eye disorders
Vision blurred
|
1.1%
1/93 • Number of events 1
|
|
Eye disorders
Watering eyes
|
1.1%
1/93 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal distension
|
5.4%
5/93 • Number of events 16
|
|
Gastrointestinal disorders
Abdominal pain
|
36.6%
34/93 • Number of events 99
|
|
Gastrointestinal disorders
Anal pain
|
1.1%
1/93 • Number of events 2
|
|
Gastrointestinal disorders
Ascites
|
2.2%
2/93 • Number of events 2
|
|
Gastrointestinal disorders
Colitis
|
1.1%
1/93 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
7.5%
7/93 • Number of events 11
|
|
Gastrointestinal disorders
Diarrhea
|
69.9%
65/93 • Number of events 467
|
|
Gastrointestinal disorders
Dry mouth
|
4.3%
4/93 • Number of events 7
|
|
Gastrointestinal disorders
Dyspepsia
|
10.8%
10/93 • Number of events 40
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
37.6%
35/93 • Number of events 99
|
|
Gastrointestinal disorders
Flatulence
|
9.7%
9/93 • Number of events 88
|
|
Gastrointestinal disorders
Gingival pain
|
1.1%
1/93 • Number of events 4
|
|
Gastrointestinal disorders
Hemorrhoids
|
1.1%
1/93 • Number of events 2
|
|
Gastrointestinal disorders
Mucositis oral
|
1.1%
1/93 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
48.4%
45/93 • Number of events 121
|
|
Gastrointestinal disorders
Oral hemorrhage
|
1.1%
1/93 • Number of events 1
|
|
Gastrointestinal disorders
Rectal fistula
|
1.1%
1/93 • Number of events 6
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
1.1%
1/93 • Number of events 1
|
|
Gastrointestinal disorders
Rectal pain
|
2.2%
2/93 • Number of events 5
|
|
Gastrointestinal disorders
Small intestinal perforation
|
1.1%
1/93 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
23.7%
22/93 • Number of events 31
|
|
General disorders
Chest pain
|
3.2%
3/93 • Number of events 3
|
|
General disorders
Chills
|
5.4%
5/93 • Number of events 8
|
|
General disorders
Edema limbs
|
8.6%
8/93 • Number of events 10
|
|
General disorders
Fatigue
|
67.7%
63/93 • Number of events 306
|
|
General disorders
Fever
|
8.6%
8/93 • Number of events 10
|
|
General disorders
Localized edema
|
3.2%
3/93 • Number of events 3
|
|
General disorders
Pain
|
4.3%
4/93 • Number of events 27
|
|
Hepatobiliary disorders
Hepatic failure
|
1.1%
1/93 • Number of events 1
|
|
Immune system disorders
Hypersensitivity
|
1.1%
1/93 • Number of events 1
|
|
Infections and infestations
Abdominal infection
|
4.3%
4/93 • Number of events 7
|
|
Infections and infestations
Anal infection
|
1.1%
1/93 • Number of events 1
|
|
Infections and infestations
Bladder infection
|
1.1%
1/93 • Number of events 1
|
|
Infections and infestations
Hepatic infection
|
1.1%
1/93 • Number of events 1
|
|
Infections and infestations
Infection
|
1.1%
1/93 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
2.2%
2/93 • Number of events 2
|
|
Infections and infestations
Prostate infection
|
1.1%
1/93 • Number of events 1
|
|
Infections and infestations
Sinusitis
|
1.1%
1/93 • Number of events 1
|
|
Infections and infestations
Skin infection
|
4.3%
4/93 • Number of events 16
|
|
Infections and infestations
Upper respiratory infection
|
4.3%
4/93 • Number of events 4
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
1.1%
1/93 • Number of events 2
|
|
Investigations
Alanine aminotransferase increased
|
22.6%
21/93 • Number of events 88
|
|
Investigations
Alkaline phosphatase increased
|
30.1%
28/93 • Number of events 163
|
|
Investigations
Aspartate aminotransferase increased
|
34.4%
32/93 • Number of events 115
|
|
Investigations
Blood bilirubin increased
|
7.5%
7/93 • Number of events 14
|
|
Investigations
Blood corticotrophin decreased
|
1.1%
1/93 • Number of events 1
|
|
Investigations
Creatine phosphokinase increased
|
1.1%
1/93 • Number of events 1
|
|
Investigations
Creatinine increased
|
15.1%
14/93 • Number of events 33
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.1%
1/93 • Number of events 1
|
|
Investigations
Laboratory test abnormal
|
2.2%
2/93 • Number of events 6
|
|
Investigations
Leukocyte count decreased
|
8.6%
8/93 • Number of events 11
|
|
Investigations
Lipase increased
|
1.1%
1/93 • Number of events 1
|
|
Investigations
Lymphocyte count decreased
|
7.5%
7/93 • Number of events 12
|
|
Investigations
Neutrophil count decreased
|
5.4%
5/93 • Number of events 8
|
|
Investigations
Platelet count decreased
|
25.8%
24/93 • Number of events 67
|
|
Investigations
Serum cholesterol increased
|
1.1%
1/93 • Number of events 1
|
|
Investigations
Weight loss
|
10.8%
10/93 • Number of events 27
|
|
Metabolism and nutrition disorders
Alkalosis
|
1.1%
1/93 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia
|
41.9%
39/93 • Number of events 100
|
|
Metabolism and nutrition disorders
Blood bicarbonate decreased
|
7.5%
7/93 • Number of events 13
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
11.8%
11/93 • Number of events 31
|
|
Metabolism and nutrition disorders
Blood uric acid increased
|
1.1%
1/93 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
1.1%
1/93 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
7.5%
7/93 • Number of events 45
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
11.8%
11/93 • Number of events 23
|
|
Metabolism and nutrition disorders
Serum glucose decreased
|
1.1%
1/93 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum magnesium increased
|
5.4%
5/93 • Number of events 8
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
6.5%
6/93 • Number of events 9
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
6.5%
6/93 • Number of events 8
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
5.4%
5/93 • Number of events 9
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
7.5%
7/93 • Number of events 9
|
|
Metabolism and nutrition disorders
Serum sodium increased
|
5.4%
5/93 • Number of events 9
|
|
Metabolism and nutrition disorders
Serum triglycerides increased
|
1.1%
1/93 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.5%
7/93 • Number of events 17
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
2.2%
2/93 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.5%
7/93 • Number of events 20
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
3.2%
3/93 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
2.2%
2/93 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.4%
19/93 • Number of events 64
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.1%
1/93 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.5%
6/93 • Number of events 7
|
|
Nervous system disorders
Accessory nerve disorder
|
1.1%
1/93 • Number of events 10
|
|
Nervous system disorders
Dizziness
|
6.5%
6/93 • Number of events 16
|
|
Nervous system disorders
Dysgeusia
|
3.2%
3/93 • Number of events 11
|
|
Nervous system disorders
Facial nerve disorder
|
1.1%
1/93 • Number of events 1
|
|
Nervous system disorders
Headache
|
9.7%
9/93 • Number of events 16
|
|
Nervous system disorders
Neurological disorder NOS
|
1.1%
1/93 • Number of events 1
|
|
Nervous system disorders
Peripheral motor neuropathy
|
3.2%
3/93 • Number of events 6
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
6.5%
6/93 • Number of events 8
|
|
Nervous system disorders
Syncope
|
1.1%
1/93 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
4.3%
4/93 • Number of events 14
|
|
Psychiatric disorders
Confusion
|
1.1%
1/93 • Number of events 2
|
|
Psychiatric disorders
Depression
|
2.2%
2/93 • Number of events 2
|
|
Psychiatric disorders
Insomnia
|
6.5%
6/93 • Number of events 11
|
|
Renal and urinary disorders
Hemoglobin urine positive
|
3.2%
3/93 • Number of events 4
|
|
Renal and urinary disorders
Renal failure
|
1.1%
1/93 • Number of events 1
|
|
Renal and urinary disorders
Urinary frequency
|
1.1%
1/93 • Number of events 2
|
|
Reproductive system and breast disorders
Vaginal pain
|
1.1%
1/93 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
1.1%
1/93 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.4%
5/93 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
24.7%
23/93 • Number of events 73
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.2%
2/93 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.1%
1/93 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
5.4%
5/93 • Number of events 27
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
49.5%
46/93 • Number of events 246
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
14.0%
13/93 • Number of events 29
|
|
Skin and subcutaneous tissue disorders
Hand-and-foot syndrome
|
55.9%
52/93 • Number of events 267
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
3.2%
3/93 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
1.1%
1/93 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.3%
4/93 • Number of events 8
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
54.8%
51/93 • Number of events 184
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
16.1%
15/93 • Number of events 21
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
1.1%
1/93 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
3.2%
3/93 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Sweating
|
6.5%
6/93 • Number of events 11
|
|
Vascular disorders
Flushing
|
6.5%
6/93 • Number of events 15
|
|
Vascular disorders
Hot flashes
|
6.5%
6/93 • Number of events 12
|
|
Vascular disorders
Hypertension
|
54.8%
51/93 • Number of events 189
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60