Trial Outcomes & Findings for Phase III Study of Sorafenib in Patients With Renal Cell Carcinoma (RCC) (NCT NCT00586105)
NCT ID: NCT00586105
Last Updated: 2014-04-16
Results Overview
The AUC(0-12h) was the observed AUC, calculated using a combination of linear and log trapezoidal rules, from pre-dose to 12 hours post-dose. The normalized AUC (AUC norm) is AUC (0-12h) divided by (dose \[mg\]/weight \[kg\]).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
39 participants
Primary outcome timeframe
12 hours after at least 21 days of uninterrupted dosing
Results posted on
2014-04-16
Participant Flow
Subjects were outpatients with histologically or cytologically confirmed, unresectable and/or metastatic, measurable clear Renal Cell Carcinoma (RCC) who had received not more than one prior systemic therapy. They were enrolled between 29 Dec 2005 and 29 Sep 2006 at 4 centers in China and 4 in Taiwan.
A total of 51 Asian subjects were enrolled in the trial. Twelve failed screening (11 protocol violations, 1 adverse event); the remaining 39 received at least 1 dose of study drug.
Participant milestones
| Measure |
Sorafenib (Nexavar, BAY43-9006)
400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)
|
|---|---|
|
Overall Study
STARTED
|
39
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
39
|
Reasons for withdrawal
| Measure |
Sorafenib (Nexavar, BAY43-9006)
400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)
|
|---|---|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
Death
|
2
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Disease progression
|
19
|
|
Overall Study
Switched to commercial drug
|
9
|
|
Overall Study
Reason not reported
|
1
|
Baseline Characteristics
Phase III Study of Sorafenib in Patients With Renal Cell Carcinoma (RCC)
Baseline characteristics by cohort
| Measure |
Sorafenib (Nexavar, BAY43-9006)
n=39 Participants
400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)
|
|---|---|
|
Renal Cell Carcinoma subtype
Predominantly clear cell
|
5 participants
n=99 Participants
|
|
Time since first progression
|
0.4 years
STANDARD_DEVIATION 0.6 • n=99 Participants
|
|
Time since initial diagnosis
|
1.7 years
STANDARD_DEVIATION 2.5 • n=99 Participants
|
|
Age, Continuous
|
58 years
STANDARD_DEVIATION 14.5 • n=99 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=99 Participants
|
|
Region of Enrollment
Taiwan
|
19 participants
n=99 Participants
|
|
Region of Enrollment
China
|
20 participants
n=99 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Scale
ECOG 0
|
20 participants
n=99 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Scale
ECOG 1
|
19 participants
n=99 Participants
|
|
Motzer risk factors
Low-risk (no risk factors)
|
21 participants
n=99 Participants
|
|
Motzer risk factors
Intermediate-risk (1 or 2 risk factors)
|
18 participants
n=99 Participants
|
|
Renal Cell Carcinoma subtype
Clear cell
|
34 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 12 hours after at least 21 days of uninterrupted dosingPopulation: A full pharmacokinetics (PK) profile was obtained in 32 of the 39 patients after at least 21 days of uninterrupted twice daily (BID) dosing.
The AUC(0-12h) was the observed AUC, calculated using a combination of linear and log trapezoidal rules, from pre-dose to 12 hours post-dose. The normalized AUC (AUC norm) is AUC (0-12h) divided by (dose \[mg\]/weight \[kg\]).
Outcome measures
| Measure |
Sorafenib (Nexavar, BAY43-9006)
n=32 Participants
400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)
|
|---|---|
|
Pharmacokinetics Measured as Area Under Curve (AUC[0-12h])
AUC (0-12h)
|
35.5 mg*hour/Liter
Standard Deviation 16.1
|
|
Pharmacokinetics Measured as Area Under Curve (AUC[0-12h])
AUC norm
|
5.7 mg*hour/Liter
Standard Deviation 3.0
|
PRIMARY outcome
Timeframe: 12 hours after at least 21 days of uninterrupted dosingPopulation: A full PK profile was obtained in 32 of the 39 patients after at least 21 days of uninterrupted BID dosing.
Cmax (maximum concentration) was measured at the time point at which the maximum concentration (Tmax) was observed. Cmin (minimum concentration) was measured at the time point at which the minimum concentration (Tmin) was observed.
Outcome measures
| Measure |
Sorafenib (Nexavar, BAY43-9006)
n=32 Participants
400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)
|
|---|---|
|
Pharmacokinetics Measured as Concentration (Cmax at Tmax and Cmin at Tmin)
Cmax
|
4.5 mg/L
Standard Deviation 2.4
|
|
Pharmacokinetics Measured as Concentration (Cmax at Tmax and Cmin at Tmin)
Cmin
|
2.0 mg/L
Standard Deviation 0.9
|
PRIMARY outcome
Timeframe: 12 hours after at least 21 days of uninterrupted dosingPopulation: A full PK profile was obtained in 32 of the 39 patients after at least 21 days of uninterrupted BID dosing.
Cmax (maximum concentration) was measured at the time point at which the maximum concentration (Tmax) was observed. Cmin (minimum concentration) was measured at the time point at which the minimum concentration (Tmin) was observed. The normalized variables (Cmax norm and Cmin norm) are the variables (Cmax and Cmin, see Primary Outcome Measure 2) divided by \[dose (mg)/weight (kg)\].
Outcome measures
| Measure |
Sorafenib (Nexavar, BAY43-9006)
n=32 Participants
400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)
|
|---|---|
|
Pharmacokinetics Measured as Concentration (Cmax Normalized at Tmax and Cmin Normalized at Tmin)
Cmax norm
|
0.7 Kg/L
Standard Deviation 0.5
|
|
Pharmacokinetics Measured as Concentration (Cmax Normalized at Tmax and Cmin Normalized at Tmin)
Cmin norm
|
0.3 Kg/L
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: Number of days from date of first dose of study drug to date first observed disease progression or death (whichever was earlier) was documented up to 17.25 monthsPopulation: All subjects who received at least 1 dose of drug (the intent to treat \[ITT\] population) were included in the analysis. Thirty-nine patients received at least 1 dose of drug.
Progression-free survival (PFS) was defined as the time from the date of receipt of first dose of study drug to disease progression, radiological or clinical, or death, whichever was earlier. Subjects still alive without tumor progression at the time of analysis were censored at their date of last tumor evaluation.
Outcome measures
| Measure |
Sorafenib (Nexavar, BAY43-9006)
n=39 Participants
400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)
|
|---|---|
|
Progression Free Survival (PFS)
|
5.5 months
Interval 4.1 to 7.8
|
SECONDARY outcome
Timeframe: Time from start of therapy to death up to 17.25 monthsPopulation: All subjects who received at least 1 dose of drug (the intent to treat \[ITT\] population) were included in the analysis. Thirty-nine patients received at least 1 dose of drug.
Overall survival (OS) was measured from the date of first dose of study drug until the date of death due to any cause. Survival time for subjects still alive at the time of analysis was censored at the date of last contact.
Outcome measures
| Measure |
Sorafenib (Nexavar, BAY43-9006)
n=39 Participants
400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)
|
|---|---|
|
Overall Survival (OS)
|
7.8 months
Interval 0.9 to 13.4
|
SECONDARY outcome
Timeframe: Time from start of study medication to clinical or radiological disease progression which ever occurs first up to 17.25 monthsPopulation: All subjects who received at least 1 dose of drug (the intent to treat \[ITT\] population) were included in the analysis. Thirty-nine patients received at least 1 dose of drug.
Time to progression (TTP) was defined as the time from date of receipt of first dose of study drug to disease progression, radiological or clinical. Subjects without tumor progression at the time of analysis were censored at their last date of tumor evaluation.
Outcome measures
| Measure |
Sorafenib (Nexavar, BAY43-9006)
n=39 Participants
400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)
|
|---|---|
|
Time to Progression (TTP)
|
5.5 months
Interval 4.1 to 7.4
|
SECONDARY outcome
Timeframe: From start to end of study medication up to 17.25 monthsPopulation: All subjects who received at least 1 dose of drug (the intent to treat \[ITT\] population) were included in the analysis. Thirty-nine patients received at least 1 dose of drug.
The DC was defined as subjects who had a best response rating of complete response (CR), partial response (PR), or stable disease (SD) according to Response Evaluation Criteria in Solid Tumors (RECIST) that was maintained for at least 28 days from the first demonstration of that rating. CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target). PR: at least a 30% decrease in the sum of longest diameters (LD) of target lesions taking as reference the baseline sum LD. SD: steady state of disease; do not qualify for PR or progressive disease (PD).
Outcome measures
| Measure |
Sorafenib (Nexavar, BAY43-9006)
n=39 Participants
400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)
|
|---|---|
|
Disease Control (DC)
disease control
|
32 participants
|
|
Disease Control (DC)
no disease control
|
6 participants
|
|
Disease Control (DC)
not evaluated
|
1 participants
|
SECONDARY outcome
Timeframe: Best response observed from start to end of study medication up to 17.25 monthsPopulation: All subjects who received at least 1 dose of drug (the intent to treat \[ITT\] population) were included in the analysis. Thirty-nine patients received at least 1 dose of drug.
The best overall response was defined as the number of subjects with a confirmed CR, PR, SD, or PD. Tumor response was evaluated using RECIST. PD: at least a 20% increase in the sum of LD of measured lesions taking as ref. the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Appearance of new lesions will also constitute PD. In exceptional circumstances, unequivocal progression of a non-measured lesion may be accepted as evidence of disease progression.
Outcome measures
| Measure |
Sorafenib (Nexavar, BAY43-9006)
n=39 Participants
400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)
|
|---|---|
|
Overall Best Response
Complete Response (CR)
|
0 participants
|
|
Overall Best Response
Partial Response (PR)
|
5 participants
|
|
Overall Best Response
Stable Disease (SD)
|
27 participants
|
|
Overall Best Response
Progressive Disease (PD)
|
6 participants
|
|
Overall Best Response
not evaluated
|
1 participants
|
SECONDARY outcome
Timeframe: From PR or CR to progression or death up to 17.25 monthsPopulation: All subjects who received at least 1 dose of drug (the intent to treat \[ITT\] population) were included in the analysis. Thirty-nine patients received at least 1 dose of drug. The overall response duration was determined on the 5 subjects who had a PR.
Overall response duration was to be calculated for subjects who had a confirmed PR or CR, defined as the time from first assessment showing a PR or CR to progression or death.
Outcome measures
| Measure |
Sorafenib (Nexavar, BAY43-9006)
n=5 Participants
400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)
|
|---|---|
|
Overall Response Duration
|
7.4 months
Interval 5.4 to 12.9
|
SECONDARY outcome
Timeframe: Time from start of study medication to first documented PR or CR up to 17.25 monthsPopulation: All subjects who received at least 1 dose of drug (the intent to treat \[ITT\] population) were included in the analysis. Thirty-nine patients received at least 1 dose of drug. Time to objective response was determined on the 5 subjects who had a PR.
Time to objective response was defined as the time from the date of receipt of first dose of study drug to first assessment showing a confirmed PR or CR.
Outcome measures
| Measure |
Sorafenib (Nexavar, BAY43-9006)
n=5 Participants
400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)
|
|---|---|
|
Time to Objective Response
|
1.4 months
Interval 1.3 to 18.3
|
Adverse Events
Sorafenib (Nexavar, BAY43-9006)
Serious events: 12 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sorafenib (Nexavar, BAY43-9006)
n=39 participants at risk
400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
2.6%
1/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
|
Blood and lymphatic system disorders
Platelets
|
2.6%
1/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
|
Gastrointestinal disorders
Anorexia
|
2.6%
1/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
|
Gastrointestinal disorders
Obstruction, GI, Small Bowel NOS
|
2.6%
1/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
|
General disorders
Fever
|
7.7%
3/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
|
General disorders
Pain, Abdomen NOS
|
2.6%
1/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
|
General disorders
No Code In CTCAE
|
7.7%
3/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
|
Infections and infestations
Infection With Normal ANC, Biliary Tree
|
2.6%
1/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
|
Infections and infestations
Infection With Normal ANC, Paranasal
|
2.6%
1/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
|
Infections and infestations
Infection With Normal ANC, Urinary Tract NOS
|
2.6%
1/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
|
Infections and infestations
Infection With Unknown ANC, Skin (Cellulitis)
|
2.6%
1/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
2.6%
1/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
|
Nervous system disorders
Dizziness
|
2.6%
1/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
|
Nervous system disorders
Seizure
|
2.6%
1/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
2.6%
1/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary - Other
|
5.1%
2/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
|
Skin and subcutaneous tissue disorders
Hand-Foot Skin Reaction
|
2.6%
1/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
|
Vascular disorders
Hemorrhage, GI, Duodenum
|
2.6%
1/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
|
Vascular disorders
Hemorrhage - Other
|
2.6%
1/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
|
Vascular disorders
Hemorrhage Pulmonary, Bronchus
|
2.6%
1/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
|
Vascular disorders
Hemorrhage, GU, Urinary NOS
|
2.6%
1/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
Other adverse events
| Measure |
Sorafenib (Nexavar, BAY43-9006)
n=39 participants at risk
400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
23.1%
9/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
|
Blood and lymphatic system disorders
PTT
|
7.7%
3/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
|
Blood and lymphatic system disorders
Edema: Limb
|
10.3%
4/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
|
Cardiac disorders
Supraventricular Arrhythmia, Sinus Tachycardia
|
5.1%
2/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
|
Cardiac disorders
Hypertension
|
17.9%
7/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
|
Ear and labyrinth disorders
Tinnitus
|
10.3%
4/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
|
Gastrointestinal disorders
Anorexia
|
28.2%
11/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
|
Gastrointestinal disorders
Constipation
|
23.1%
9/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
|
Gastrointestinal disorders
Diarrhea
|
35.9%
14/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
|
Gastrointestinal disorders
Distension
|
7.7%
3/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
|
Gastrointestinal disorders
Mucositis (Functional/Symptomatic), Oral Cavity
|
7.7%
3/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
|
Gastrointestinal disorders
Mucositis (Clinical Exam), Oral Cavity
|
5.1%
2/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
|
Gastrointestinal disorders
Nausea
|
7.7%
3/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
|
Gastrointestinal disorders
GI - Other
|
5.1%
2/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
|
Gastrointestinal disorders
Periodontal
|
5.1%
2/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
|
Gastrointestinal disorders
Vomiting
|
12.8%
5/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
|
General disorders
Fever
|
12.8%
5/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
|
General disorders
Weight Gain
|
5.1%
2/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
|
General disorders
Insomnia
|
5.1%
2/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
|
General disorders
Fatigue
|
30.8%
12/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
|
General disorders
Weight Loss
|
23.1%
9/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
|
General disorders
Pain, Back
|
12.8%
5/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
|
General disorders
Pain, Chest/Thorax NOS
|
5.1%
2/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
|
General disorders
Pain, Chest Wall
|
5.1%
2/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
|
General disorders
Pain, Dental/Teeth/Peridontal
|
5.1%
2/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
|
General disorders
Pain, Extremity - Limb
|
5.1%
2/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
|
General disorders
Pain, Abdomen NOS
|
12.8%
5/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
|
General disorders
Pain, Head/Headache
|
7.7%
3/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
|
General disorders
Pain, Joint
|
12.8%
5/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
|
General disorders
Pain, Bone
|
17.9%
7/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
|
General disorders
Pain, Other
|
5.1%
2/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
|
General disorders
Pain, Stomach
|
10.3%
4/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
|
General disorders
Flu-Like Syndrome
|
7.7%
3/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
|
Infections and infestations
Infection With Normal ANC, Urinary Tract NOS
|
5.1%
2/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
|
Infections and infestations
Infection - Other
|
5.1%
2/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
|
Infections and infestations
Infection With Unknown ANC, Skin (Cellulitis)
|
5.1%
2/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
|
Metabolism and nutrition disorders
Alkaline Phosphatase
|
5.1%
2/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
|
Metabolism and nutrition disorders
ALT
|
17.9%
7/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
|
Metabolism and nutrition disorders
Amylase
|
5.1%
2/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
|
Metabolism and nutrition disorders
AST
|
20.5%
8/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
|
Metabolism and nutrition disorders
Creatinine
|
10.3%
4/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
|
Metabolism and nutrition disorders
Bilirubin (Hyperbilirubinemia)
|
15.4%
6/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
5.1%
2/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
5.1%
2/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
20.5%
8/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
12.8%
5/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
|
Metabolism and nutrition disorders
Lipase
|
12.8%
5/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
23.1%
9/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
|
Metabolism and nutrition disorders
Metabolic/Lab - Other
|
15.4%
6/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
5.1%
2/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
|
Nervous system disorders
Dizziness
|
5.1%
2/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
|
Renal and urinary disorders
Incontinence, Urinary
|
7.7%
3/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
28.2%
11/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal/Paranasal Reactions
|
5.1%
2/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (Shortness Of Breath)
|
7.7%
3/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
|
Respiratory, thoracic and mediastinal disorders
Voice Changes
|
12.8%
5/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
|
Skin and subcutaneous tissue disorders
Acne
|
15.4%
6/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
35.9%
14/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
|
Skin and subcutaneous tissue disorders
Hand-Foot Skin Reaction
|
64.1%
25/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
15.4%
6/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
|
Skin and subcutaneous tissue disorders
Rash/Desquamation
|
23.1%
9/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
|
Skin and subcutaneous tissue disorders
Flushing
|
7.7%
3/39 • From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60