Trial Outcomes & Findings for Dual Epidermal Growth Factor Receptor Inhibition With Erlotinib and Panitumumab With or Without Chemotherapy for Advanced Colorectal Cancer (NCT NCT00940316)
NCT ID: NCT00940316
Last Updated: 2019-05-07
Results Overview
Tumor response rate will be measured by CT scan of the chest and CT scan or MRI scan of abdomen and pelvis every 8 weeks until disease progression response rate will be measured per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions evaluated using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD)of target lesions, taking as reference the baseline sum LD. Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions,taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
28 participants
Primary outcome timeframe
At baseline and every 8 weeks during treatment until progressive disease for maximum of 51 cycles where 1 cycle = 2 weeks.
Results posted on
2019-05-07
Participant Flow
The study opened for accrual on July 9, 2009 with an accrual goal of up to 96 patients. The study was designed to enroll 13 patients on each arm and do an interim efficacy assessment. Accrual was suspended on March 31 2015 fand closed permanently on April 13, 2015 with 28 patients enrolled on the study.
Subjects with either 6/6 UGT1A1 genotype or 6/7 UGT1A1 genotype will be randomized into either Arm A and Arm B. Subjects with 7/7 UGT1A1 genotype enrolled in Arm C.
Participant milestones
| Measure |
Arm A: Erlotinib + Panitumumab + Irinotecan
Patients receive oral erlotinib hydrochloride once daily on days 1-14, panitumumab IV over 30-90 minutes on day 1, and irinotecan hydrochloride IV over 90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity.
panitumumab: Given intravenously 6mg/kg every 2 weeks
erlotinib hydrochloride: Given orally 150mg daily
irinotecan hydrochloride: Given intravenously 120mg/m2 for 6/6 genotype and 60mg/m2 for 6/7 genotype
|
Arm B: Erlotinib + Panitumumab
Patients receive oral erlotinib hydrochloride once daily on days 1-14 and panitumumab IV over 30-90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients receive irinotecan hydrochloride as in arm A.
panitumumab: Given intravenously 6mg/kg every 2 weeks
erlotinib hydrochloride: Given orally 150mg daily
irinotecan hydrochloride: Given intravenously 120mg/m2 for 6/6 genotype and 60mg/m2 for 6/7 genotype
|
Arm C: Erlotinib + Panitumumab
Patients receive erlotinib hydrochloride and panitumumab as in arm B.
panitumumab: Given intravenously 6mg/kg every 2 weeks
erlotinib hydrochloride: Given orally 150mg daily
|
|---|---|---|---|
|
Reached First Response at 8 Weeks
STARTED
|
13
|
13
|
2
|
|
Reached First Response at 8 Weeks
COMPLETED
|
10
|
9
|
2
|
|
Reached First Response at 8 Weeks
NOT COMPLETED
|
3
|
4
|
0
|
|
Moved on to be Treated Cycle 5
STARTED
|
10
|
9
|
2
|
|
Moved on to be Treated Cycle 5
COMPLETED
|
8
|
9
|
2
|
|
Moved on to be Treated Cycle 5
NOT COMPLETED
|
2
|
0
|
0
|
|
Treated After Cycle 5
STARTED
|
8
|
9
|
2
|
|
Treated After Cycle 5
COMPLETED
|
8
|
8
|
1
|
|
Treated After Cycle 5
NOT COMPLETED
|
0
|
1
|
1
|
|
Crossed Over to Arm A After Progression
STARTED
|
0
|
3
|
0
|
|
Crossed Over to Arm A After Progression
Treated for Cycle One
|
0
|
3
|
0
|
|
Crossed Over to Arm A After Progression
COMPLETED
|
0
|
3
|
0
|
|
Crossed Over to Arm A After Progression
NOT COMPLETED
|
0
|
0
|
0
|
|
Follow up Every 3 Months
STARTED
|
13
|
13
|
2
|
|
Follow up Every 3 Months
COMPLETED
|
13
|
13
|
2
|
|
Follow up Every 3 Months
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Arm A: Erlotinib + Panitumumab + Irinotecan
Patients receive oral erlotinib hydrochloride once daily on days 1-14, panitumumab IV over 30-90 minutes on day 1, and irinotecan hydrochloride IV over 90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity.
panitumumab: Given intravenously 6mg/kg every 2 weeks
erlotinib hydrochloride: Given orally 150mg daily
irinotecan hydrochloride: Given intravenously 120mg/m2 for 6/6 genotype and 60mg/m2 for 6/7 genotype
|
Arm B: Erlotinib + Panitumumab
Patients receive oral erlotinib hydrochloride once daily on days 1-14 and panitumumab IV over 30-90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients receive irinotecan hydrochloride as in arm A.
panitumumab: Given intravenously 6mg/kg every 2 weeks
erlotinib hydrochloride: Given orally 150mg daily
irinotecan hydrochloride: Given intravenously 120mg/m2 for 6/6 genotype and 60mg/m2 for 6/7 genotype
|
Arm C: Erlotinib + Panitumumab
Patients receive erlotinib hydrochloride and panitumumab as in arm B.
panitumumab: Given intravenously 6mg/kg every 2 weeks
erlotinib hydrochloride: Given orally 150mg daily
|
|---|---|---|---|
|
Reached First Response at 8 Weeks
Adverse Event
|
2
|
1
|
0
|
|
Reached First Response at 8 Weeks
Progressive disease
|
1
|
3
|
0
|
|
Moved on to be Treated Cycle 5
Adverse Event
|
2
|
0
|
0
|
|
Treated After Cycle 5
Adverse Event
|
0
|
0
|
1
|
|
Treated After Cycle 5
Progressive disease
|
0
|
1
|
0
|
Baseline Characteristics
Dual Epidermal Growth Factor Receptor Inhibition With Erlotinib and Panitumumab With or Without Chemotherapy for Advanced Colorectal Cancer
Baseline characteristics by cohort
| Measure |
Arm A: Erlotinib + Panitumumab + Irinotecan
n=13 Participants
Patients receive oral erlotinib hydrochloride once daily on days 1-14, panitumumab IV over 30-90 minutes on day 1, and irinotecan hydrochloride IV over 90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity.
panitumumab: Given intravenously 6mg/kg every 2 weeks
erlotinib hydrochloride: Given orally 150mg daily
irinotecan hydrochloride: Given intravenously 120mg/m2 for 6/6 genotype and 60mg/m2 for 6/7 genotype
|
Arm B: Erlotinib + Panitumumab
n=13 Participants
Patients receive oral erlotinib hydrochloride once daily on days 1-14 and panitumumab IV over 30-90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients receive irinotecan hydrochloride as in arm A.
panitumumab: Given intravenously 6mg/kg every 2 weeks
erlotinib hydrochloride: Given orally 150mg daily
irinotecan hydrochloride: Given intravenously 120mg/m2 for 6/6 genotype and 60mg/m2 for 6/7 genotype
|
Arm C: Erlotinib + Panitumumab
n=2 Participants
Patients receive erlotinib hydrochloride and panitumumab as in arm B.
panitumumab: Given intravenously 6mg/kg every 2 weeks
erlotinib hydrochloride: Given orally 150mg daily
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
UGT1A1 genotyping 6/6
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
UGT1A1 genotyping 6/7
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
UGT1A1 genotyping 7/7
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: At baseline and every 8 weeks during treatment until progressive disease for maximum of 51 cycles where 1 cycle = 2 weeks.Tumor response rate will be measured by CT scan of the chest and CT scan or MRI scan of abdomen and pelvis every 8 weeks until disease progression response rate will be measured per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions evaluated using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD)of target lesions, taking as reference the baseline sum LD. Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions,taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started
Outcome measures
| Measure |
Arm A: Erlotinib + Panitumumab + Irinotecan
n=13 Participants
Arm A - Patients receive oral erlotinib hydrochloride once daily on days 1-14, panitumumab IV over 30-90 minutes on day 1, and irinotecan hydrochloride IV over 90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity.
panitumumab: Given intravenously 6mg/kg every 2 weeks
erlotinib hydrochloride: Given orally 150mg daily
Irinotecan hydrochloride: Given intravenously 120mg/m2 every 2 weeks
|
Arm B: Erlotinib + Panitumumab
n=13 Participants
Arm B - Patients receive oral erlotinib hydrochloride once daily on days 1-14 and panitumumab IV over 30-90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients receive irinotecan hydrochloride as in arm A.
panitumumab: Given intravenously 6mg/kg every 2 weeks
erlotinib hydrochloride: Given orally 150mg daily
|
Arm C: Erlotinib + Panitumumab
n=2 Participants
Arm C - Patients receive erlotinib hydrochloride and panitumumab as in arm B.
panitumumab: Given intravenously 6mg/kg every 2 weeks
erlotinib hydrochloride: Given orally 150mg daily
|
Arm B Cross Over - Erlotinib + Panitumumab + Irinotecan
Patients receive oral erlotinib hydrochloride once daily on days 1-14 and panitumumab IV over 30-90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients receive irinotecan hydrochloride as in arm A.
panitumumab: Given intravenously 6mg/kg every 2 weeks
erlotinib hydrochloride: Given orally 150mg daily
irinotecan hydrochloride: Given intravenously 120mg/m2 for 6/6 genotype and 60mg/m2 for 6/7 genotype
After progression patients cross over to Arm A and Irinotecan is added. irinotecan hydrochloride IV over 90 minutes on day 1 or a 14 day cycle.
|
|---|---|---|---|---|
|
Tumor Response Rate Based on Complete Response (CR)+ Partial Response (PR) + Stable Disease (SD)
Complete Response
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Tumor Response Rate Based on Complete Response (CR)+ Partial Response (PR) + Stable Disease (SD)
Partial Response
|
4 Participants
|
3 Participants
|
0 Participants
|
—
|
|
Tumor Response Rate Based on Complete Response (CR)+ Partial Response (PR) + Stable Disease (SD)
Stable disease
|
6 Participants
|
3 Participants
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: At baseline and every 8 weeks during treatment until disease progression and for a maximum of 51 cycles where 1 cycle = 2 weeksPopulation: All patient data analyzed reported together regardless of arm allocation. Data not collected and analyzed for this outcome measure.
Time to disease progression will be measured by CT scan of the chest and CT scan or MRI scan of abdomen and pelvis every 8 weeks until disease progression . Time to disease progression will be defined as the time elapsed from the day of 1st study drug administration to the day disease progression is documented or death occurs and will . Progressive Disease will be defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) : At least a 20% increase in the sum of the longest diameter (LD) of target lesions,taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From first day of study drug treatment until the date of stopping all study drugs for any reason for a maximum of 51 cycles where 1 cycle=2weeksPopulation: Data was not collected and analyzed for this outcome measure
Time to treatment failure will be measured as the time elapsed from the day of first study drug administration to the date a subject stops all study drugs for any reason.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 of every 2 week treatment cycle while on study treatment and 30 days after the last treatment for a maximum of 51 cycles.Data on the toxicity of the combination of study drugs is assessed by laboratory blood draws done on day 1 of every treatment cycle and by patient report while on study treatment and up to 30 days after the last treatment. Grade 3 and grade 4 adverse events (AE) where the relationship between the AE and at least one of the study drugs were considered to be definite, probable or possible, were collected using National Cancer Institute's Common Toxicity Criteria for adverse events version 3.0 (CTCAE v3.0). AEs are graded as: Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE
Outcome measures
| Measure |
Arm A: Erlotinib + Panitumumab + Irinotecan
n=13 Participants
Arm A - Patients receive oral erlotinib hydrochloride once daily on days 1-14, panitumumab IV over 30-90 minutes on day 1, and irinotecan hydrochloride IV over 90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity.
panitumumab: Given intravenously 6mg/kg every 2 weeks
erlotinib hydrochloride: Given orally 150mg daily
Irinotecan hydrochloride: Given intravenously 120mg/m2 every 2 weeks
|
Arm B: Erlotinib + Panitumumab
n=10 Participants
Arm B - Patients receive oral erlotinib hydrochloride once daily on days 1-14 and panitumumab IV over 30-90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients receive irinotecan hydrochloride as in arm A.
panitumumab: Given intravenously 6mg/kg every 2 weeks
erlotinib hydrochloride: Given orally 150mg daily
|
Arm C: Erlotinib + Panitumumab
n=2 Participants
Arm C - Patients receive erlotinib hydrochloride and panitumumab as in arm B.
panitumumab: Given intravenously 6mg/kg every 2 weeks
erlotinib hydrochloride: Given orally 150mg daily
|
Arm B Cross Over - Erlotinib + Panitumumab + Irinotecan
n=3 Participants
Patients receive oral erlotinib hydrochloride once daily on days 1-14 and panitumumab IV over 30-90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients receive irinotecan hydrochloride as in arm A.
panitumumab: Given intravenously 6mg/kg every 2 weeks
erlotinib hydrochloride: Given orally 150mg daily
irinotecan hydrochloride: Given intravenously 120mg/m2 for 6/6 genotype and 60mg/m2 for 6/7 genotype
After progression patients cross over to Arm A and Irinotecan is added. irinotecan hydrochloride IV over 90 minutes on day 1 or a 14 day cycle.
|
|---|---|---|---|---|
|
Toxicity of the Combination of Study Drugs
Hemoglobin decrease
|
3 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Toxicity of the Combination of Study Drugs
Leukocyte decrease
|
7 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Toxicity of the Combination of Study Drugs
Lymphopenia
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Toxicity of the Combination of Study Drugs
Neutrophil decrease
|
7 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Toxicity of the Combination of Study Drugs
Fatigue
|
1 participants
|
1 participants
|
1 participants
|
0 participants
|
|
Toxicity of the Combination of Study Drugs
Dry skin
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Toxicity of the Combination of Study Drugs
Rash/desquamation
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Toxicity of the Combination of Study Drugs
Rash: Hand-foot skin reaction
|
4 participants
|
7 participants
|
2 participants
|
0 participants
|
|
Toxicity of the Combination of Study Drugs
Anorexia
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Toxicity of the Combination of Study Drugs
Diarrhea
|
6 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Toxicity of the Combination of Study Drugs
Nausea
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Toxicity of the Combination of Study Drugs
Infection
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Toxicity of the Combination of Study Drugs
Alkaline phosphatase decrease
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
|
Toxicity of the Combination of Study Drugs
Magnesium decrease
|
5 participants
|
4 participants
|
1 participants
|
0 participants
|
|
Toxicity of the Combination of Study Drugs
Phosphate decrease
|
2 participants
|
1 participants
|
3 participants
|
0 participants
|
|
Toxicity of the Combination of Study Drugs
Sodium decrease
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Toxicity of the Combination of Study Drugs
Syncope/fainting
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Toxicity of the Combination of Study Drugs
Pruritus/itching
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: At baseline and at a time-point reflecting maximum rash intensity during treatment, at a maximum of 51 cycles.Population: All patient data analyzed reported together regardless of arm allocation.This outcome measure was based on optional biopsies that patients were required to consent to. Data was not collected or analyzed for this outcome measure.
Effect on downstream targets of EGFR in skin rash associated with pharmacologic EGFR inhibition. Skin biopsies will be performed at baseline (before the first days of treatment) and and at a time-point reflecting maximum rash intensity determined by a dermatologist.
Outcome measures
Outcome data not reported
POST_HOC outcome
Timeframe: From the time of first treatment to deathMedian Overall Survival (OS) is measured from treatment initiation until death due to any cause.
Outcome measures
| Measure |
Arm A: Erlotinib + Panitumumab + Irinotecan
n=13 Participants
Arm A - Patients receive oral erlotinib hydrochloride once daily on days 1-14, panitumumab IV over 30-90 minutes on day 1, and irinotecan hydrochloride IV over 90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity.
panitumumab: Given intravenously 6mg/kg every 2 weeks
erlotinib hydrochloride: Given orally 150mg daily
Irinotecan hydrochloride: Given intravenously 120mg/m2 every 2 weeks
|
Arm B: Erlotinib + Panitumumab
n=13 Participants
Arm B - Patients receive oral erlotinib hydrochloride once daily on days 1-14 and panitumumab IV over 30-90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients receive irinotecan hydrochloride as in arm A.
panitumumab: Given intravenously 6mg/kg every 2 weeks
erlotinib hydrochloride: Given orally 150mg daily
|
Arm C: Erlotinib + Panitumumab
n=2 Participants
Arm C - Patients receive erlotinib hydrochloride and panitumumab as in arm B.
panitumumab: Given intravenously 6mg/kg every 2 weeks
erlotinib hydrochloride: Given orally 150mg daily
|
Arm B Cross Over - Erlotinib + Panitumumab + Irinotecan
Patients receive oral erlotinib hydrochloride once daily on days 1-14 and panitumumab IV over 30-90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients receive irinotecan hydrochloride as in arm A.
panitumumab: Given intravenously 6mg/kg every 2 weeks
erlotinib hydrochloride: Given orally 150mg daily
irinotecan hydrochloride: Given intravenously 120mg/m2 for 6/6 genotype and 60mg/m2 for 6/7 genotype
After progression patients cross over to Arm A and Irinotecan is added. irinotecan hydrochloride IV over 90 minutes on day 1 or a 14 day cycle.
|
|---|---|---|---|---|
|
Median Overall Survival
|
12.6 Months
Interval 4.8 to 19.4
|
8.6 Months
Interval 3.1 to 30.1
|
2.4 Months
Sample size to small to calculate confidence interval
|
—
|
POST_HOC outcome
Timeframe: At baseline and every 8 weeks during treatment until disease progression and for a maximum of 51 cycles where 1 cycle = 2 weeksProgression free survival will be measured every 8 weeks during treatment by CT or MRI scans. Progression is defined using Response Evaluation Criteria in Solid Tumors (RECIST). Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Outcome measures
| Measure |
Arm A: Erlotinib + Panitumumab + Irinotecan
n=12 Participants
Arm A - Patients receive oral erlotinib hydrochloride once daily on days 1-14, panitumumab IV over 30-90 minutes on day 1, and irinotecan hydrochloride IV over 90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity.
panitumumab: Given intravenously 6mg/kg every 2 weeks
erlotinib hydrochloride: Given orally 150mg daily
Irinotecan hydrochloride: Given intravenously 120mg/m2 every 2 weeks
|
Arm B: Erlotinib + Panitumumab
n=13 Participants
Arm B - Patients receive oral erlotinib hydrochloride once daily on days 1-14 and panitumumab IV over 30-90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients receive irinotecan hydrochloride as in arm A.
panitumumab: Given intravenously 6mg/kg every 2 weeks
erlotinib hydrochloride: Given orally 150mg daily
|
Arm C: Erlotinib + Panitumumab
n=2 Participants
Arm C - Patients receive erlotinib hydrochloride and panitumumab as in arm B.
panitumumab: Given intravenously 6mg/kg every 2 weeks
erlotinib hydrochloride: Given orally 150mg daily
|
Arm B Cross Over - Erlotinib + Panitumumab + Irinotecan
Patients receive oral erlotinib hydrochloride once daily on days 1-14 and panitumumab IV over 30-90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients receive irinotecan hydrochloride as in arm A.
panitumumab: Given intravenously 6mg/kg every 2 weeks
erlotinib hydrochloride: Given orally 150mg daily
irinotecan hydrochloride: Given intravenously 120mg/m2 for 6/6 genotype and 60mg/m2 for 6/7 genotype
After progression patients cross over to Arm A and Irinotecan is added. irinotecan hydrochloride IV over 90 minutes on day 1 or a 14 day cycle.
|
|---|---|---|---|---|
|
Progression Free Survival (PFS)
|
4.6 Months
Interval 1.4 to 8.2
|
3.8 Months
Interval 1.5 to 5.9
|
2.4 Months
Sample size too small to calculate confidence interval
|
—
|
Adverse Events
Arm A: Erlotinib + Panitumumab + Irinotecan
Serious events: 3 serious events
Other events: 13 other events
Deaths: 11 deaths
Arm B: Erlotinib + Panitumumab
Serious events: 4 serious events
Other events: 10 other events
Deaths: 10 deaths
Arm C: Erlotinib + Panitumumab
Serious events: 1 serious events
Other events: 2 other events
Deaths: 1 deaths
Arm B Cross Over - Erlotinib + Panitumumab + Irinotecan
Serious events: 1 serious events
Other events: 3 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Arm A: Erlotinib + Panitumumab + Irinotecan
n=13 participants at risk
Patients receive oral erlotinib hydrochloride once daily on days 1-14, panitumumab IV over 30-90 minutes on day 1, and irinotecan hydrochloride IV over 90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity.
panitumumab: Given intravenously 6mg/kg every 2 weeks
erlotinib hydrochloride: Given orally 150mg daily
irinotecan hydrochloride: Given intravenously 120mg/m2 for 6/6 genotype and 60mg/m2 for 6/7 genotype
|
Arm B: Erlotinib + Panitumumab
n=10 participants at risk
Patients receive oral erlotinib hydrochloride once daily on days 1-14 and panitumumab IV over 30-90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients receive irinotecan hydrochloride as in arm A.
panitumumab: Given intravenously 6mg/kg every 2 weeks
erlotinib hydrochloride: Given orally 150mg daily
irinotecan hydrochloride: Given intravenously 120mg/m2 for 6/6 genotype and 60mg/m2 for 6/7 genotype
|
Arm C: Erlotinib + Panitumumab
n=2 participants at risk
Patients receive erlotinib hydrochloride and panitumumab as in arm B.
panitumumab: Given intravenously 6mg/kg every 2 weeks
erlotinib hydrochloride: Given orally 150mg daily
|
Arm B Cross Over - Erlotinib + Panitumumab + Irinotecan
n=3 participants at risk
Patients receive oral erlotinib hydrochloride once daily on days 1-14 and panitumumab IV over 30-90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity.
Upon disease progression, patients receive irinotecan hydrochloride as in arm A.
panitumumab: Given intravenously 6mg/kg every 2 weeks
erlotinib hydrochloride: Given orally 150mg daily
irinotecan hydrochloride: Given intravenously 120mg/m2 for 6/6 genotype and 60mg/m2 for 6/7 genotype
After progression patients cross over to Arm A and Irinotecan is added. irinotecan hydrochloride IV over 90 minutes on day 1 or a 14 day cycle.
|
|---|---|---|---|---|
|
Investigations
Hypoglycemia
|
0.00%
0/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
33.3%
1/3 • Number of events 1 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Gastrointestinal disorders
Small bowel obstruction
|
7.7%
1/13 • Number of events 1 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death NOS- progressive disease
|
7.7%
1/13 • Number of events 1 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Gastrointestinal disorders
Partial Small Bowel Obstruction
|
0.00%
0/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Blood and lymphatic system disorders
Neutropenic fever
|
7.7%
1/13 • Number of events 1 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Renal and urinary disorders
Urinary Track infection
|
0.00%
0/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
50.0%
1/2 • Number of events 1 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
50.0%
1/2 • Number of events 1 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Infections and infestations
Pneumonia
|
0.00%
0/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Infections and infestations
Bronchitis
|
0.00%
0/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Nervous system disorders
Altered mental status
|
0.00%
0/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
Other adverse events
| Measure |
Arm A: Erlotinib + Panitumumab + Irinotecan
n=13 participants at risk
Patients receive oral erlotinib hydrochloride once daily on days 1-14, panitumumab IV over 30-90 minutes on day 1, and irinotecan hydrochloride IV over 90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity.
panitumumab: Given intravenously 6mg/kg every 2 weeks
erlotinib hydrochloride: Given orally 150mg daily
irinotecan hydrochloride: Given intravenously 120mg/m2 for 6/6 genotype and 60mg/m2 for 6/7 genotype
|
Arm B: Erlotinib + Panitumumab
n=10 participants at risk
Patients receive oral erlotinib hydrochloride once daily on days 1-14 and panitumumab IV over 30-90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients receive irinotecan hydrochloride as in arm A.
panitumumab: Given intravenously 6mg/kg every 2 weeks
erlotinib hydrochloride: Given orally 150mg daily
irinotecan hydrochloride: Given intravenously 120mg/m2 for 6/6 genotype and 60mg/m2 for 6/7 genotype
|
Arm C: Erlotinib + Panitumumab
n=2 participants at risk
Patients receive erlotinib hydrochloride and panitumumab as in arm B.
panitumumab: Given intravenously 6mg/kg every 2 weeks
erlotinib hydrochloride: Given orally 150mg daily
|
Arm B Cross Over - Erlotinib + Panitumumab + Irinotecan
n=3 participants at risk
Patients receive oral erlotinib hydrochloride once daily on days 1-14 and panitumumab IV over 30-90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity.
Upon disease progression, patients receive irinotecan hydrochloride as in arm A.
panitumumab: Given intravenously 6mg/kg every 2 weeks
erlotinib hydrochloride: Given orally 150mg daily
irinotecan hydrochloride: Given intravenously 120mg/m2 for 6/6 genotype and 60mg/m2 for 6/7 genotype
After progression patients cross over to Arm A and Irinotecan is added. irinotecan hydrochloride IV over 90 minutes on day 1 or a 14 day cycle.
|
|---|---|---|---|---|
|
Ear and labyrinth disorders
Otitis, external ear (non-infectious)
|
7.7%
1/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Blood and lymphatic system disorders
Hemoglobin (Anemia)
|
69.2%
9/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
80.0%
8/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
50.0%
1/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
66.7%
2/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Ear and labyrinth disorders
Hearing: patients without baseline audiogram and not enrolled in a monitoring
|
7.7%
1/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Blood and lymphatic system disorders
Neutrophils (neutropenia)
|
46.2%
6/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
10.0%
1/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
33.3%
1/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Blood and lymphatic system disorders
Leukocytes (total white blood cells)
|
69.2%
9/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
10.0%
1/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
33.3%
1/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Blood and lymphatic system disorders
lymphopenia
|
46.2%
6/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
20.0%
2/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Blood and lymphatic system disorders
Platelets (thrombocytopenia)
|
15.4%
2/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
10.0%
1/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
33.3%
1/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Blood and lymphatic system disorders
Elevated BUN
|
7.7%
1/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Cardiac disorders
Hypertension
|
30.8%
4/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
20.0%
2/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Cardiac disorders
Hypotension
|
7.7%
1/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
33.3%
1/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
General disorders
Fatigue
|
61.5%
8/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
40.0%
4/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
33.3%
1/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
General disorders
Fever
|
23.1%
3/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
10.0%
1/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
General disorders
Insomnia
|
7.7%
1/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
General disorders
Rigors
|
15.4%
2/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
General disorders
Weight loss
|
15.4%
2/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
10.0%
1/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Investigations
International Normalized Ratio of prothrombin time (INR)
|
0.00%
0/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
10.0%
1/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Skin and subcutaneous tissue disorders
Cheilitis
|
7.7%
1/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Skin and subcutaneous tissue disorders
Hair loss (alopecia)
|
23.1%
3/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
10.0%
1/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
7.7%
1/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
15.4%
2/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
15.4%
2/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
20.0%
2/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Skin and subcutaneous tissue disorders
Acne/acneiform
|
69.2%
9/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
100.0%
10/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
50.0%
1/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
66.7%
2/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
15.4%
2/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
10.0%
1/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Skin and subcutaneous tissue disorders
Rash: Hand-foot skin reaction
|
15.4%
2/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
20.0%
2/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
30.8%
4/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
50.0%
1/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
15.4%
2/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Skin and subcutaneous tissue disorders
Paronychia
|
7.7%
1/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Skin and subcutaneous tissue disorders
Fungal infection beneath left breast
|
7.7%
1/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Skin and subcutaneous tissue disorders
Pseudomonas
|
7.7%
1/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Skin and subcutaneous tissue disorders
Extensive growth of eyelashes
|
7.7%
1/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Skin and subcutaneous tissue disorders
Scalp rash
|
0.00%
0/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
50.0%
1/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Skin and subcutaneous tissue disorders
Face rash
|
0.00%
0/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
50.0%
1/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Endocrine disorders
Glucose intolerance
|
7.7%
1/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Gastrointestinal disorders
Anorexia
|
30.8%
4/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
10.0%
1/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
33.3%
1/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Gastrointestinal disorders
Constipation
|
38.5%
5/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
10.0%
1/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Gastrointestinal disorders
Diarrhea
|
69.2%
9/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
50.0%
5/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
100.0%
3/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Gastrointestinal disorders
Distension/bloating of abdomen
|
7.7%
1/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
33.3%
1/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Gastrointestinal disorders
Mucositis/stomatitis
|
30.8%
4/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
33.3%
1/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Gastrointestinal disorders
Heartburn (dyspepsia)
|
0.00%
0/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
10.0%
1/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Gastrointestinal disorders
Nausea
|
53.8%
7/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
30.0%
3/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
66.7%
2/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Gastrointestinal disorders
Taste alteration (dysgeusia)
|
15.4%
2/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Gastrointestinal disorders
Vomiting
|
23.1%
3/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Gastrointestinal disorders
Retal burning
|
7.7%
1/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Gastrointestinal disorders
Colon cancer with liver metastasis and likely bone metastasis
|
7.7%
1/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
General disorders
Nosebleed
|
7.7%
1/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Gastrointestinal disorders
Hemorrhoids
|
7.7%
1/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Infections and infestations
Infection in pelvis (with normal ANC or grade 1 or 2 neutrophils)
|
7.7%
1/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Infections and infestations
Infection in upper airway (with normal ANC or Grade 1 or 2 neutrophils)
|
0.00%
0/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
10.0%
1/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Infections and infestations
Infection in abdomen (with normal ANC or Grade 1 or 2 neutrophils)
|
0.00%
0/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
10.0%
1/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Infections and infestations
Infection in urinary tract (unknown ANC)
|
7.7%
1/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Infections and infestations
Paronychia (infection with grade 3 or 4 neutrophils)
|
0.00%
0/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
33.3%
1/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Infections and infestations
Skin infection (Cellulitis)
|
0.00%
0/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
10.0%
1/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
33.3%
1/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Infections and infestations
Ear infection
|
15.4%
2/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Infections and infestations
Pseudomonas Bactermia
|
7.7%
1/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Infections and infestations
Escherichia coli
|
7.7%
1/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Blood and lymphatic system disorders
Edema - limb
|
0.00%
0/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
20.0%
2/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
61.5%
8/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
30.0%
3/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
66.7%
2/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Metabolism and nutrition disorders
Alkaline phosphatase increase
|
38.5%
5/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
60.0%
6/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
100.0%
2/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
66.7%
2/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Metabolism and nutrition disorders
ALT increase (serum glutamic pyruvic transaminase)
|
38.5%
5/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
20.0%
2/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
50.0%
1/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
66.7%
2/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Metabolism and nutrition disorders
AST increase (serum glutamic oxaloacetic transaminase)
|
61.5%
8/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
60.0%
6/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
100.0%
2/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
100.0%
3/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Metabolism and nutrition disorders
Bilirubin increase (hyperbilirubinemia)
|
46.2%
6/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
40.0%
4/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
50.0%
1/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
66.7%
2/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Metabolism and nutrition disorders
Creatinine increase
|
7.7%
1/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Metabolism and nutrition disorders
Creatine phosphokinase (CPK)
|
7.7%
1/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Metabolism and nutrition disorders
Calcium, serum high (hypercalcemia)
|
7.7%
1/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Metabolism and nutrition disorders
Calcium, serum low (hypocalcemia)
|
53.8%
7/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
20.0%
2/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
66.7%
2/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Metabolism and nutrition disorders
Glucose, serum high (hyperglycemia)
|
53.8%
7/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
40.0%
4/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Metabolism and nutrition disorders
Magnesium, serum low (hypomagnesemia)
|
76.9%
10/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
100.0%
10/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
100.0%
2/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
100.0%
3/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Metabolism and nutrition disorders
Phosphate, serum low (hypophosphatemia)
|
46.2%
6/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
30.0%
3/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
100.0%
3/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Metabolism and nutrition disorders
Potassium, serum high (hyperkalemia)
|
7.7%
1/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
10.0%
1/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Metabolism and nutrition disorders
Potassium, serum low (hypokalemia)
|
76.9%
10/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
60.0%
6/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
50.0%
1/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
100.0%
3/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Metabolism and nutrition disorders
Sodium, se high (hypernatremia)
|
23.1%
3/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
30.0%
3/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
33.3%
1/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Metabolism and nutrition disorders
Sodium, serum low (hyponatremia)
|
30.8%
4/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
30.0%
3/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
100.0%
2/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
33.3%
1/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Nervous system disorders
Sensory Neuropathy
|
0.00%
0/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
10.0%
1/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
50.0%
1/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Nervous system disorders
Confusion
|
7.7%
1/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Nervous system disorders
Dizziness
|
23.1%
3/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
10.0%
1/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
50.0%
1/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
33.3%
1/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Metabolism and nutrition disorders
Depression
|
0.00%
0/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
33.3%
1/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Nervous system disorders
Fainting (syncope episode)
|
7.7%
1/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness generalized
|
7.7%
1/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Metabolism and nutrition disorders
Neck stiffness
|
7.7%
1/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Musculoskeletal and connective tissue disorders
Muscle cramps
|
7.7%
1/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
7.7%
1/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Musculoskeletal and connective tissue disorders
Abdomen pain
|
30.8%
4/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
40.0%
4/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
33.3%
1/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.7%
1/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Musculoskeletal and connective tissue disorders
Extremity/limb pain
|
7.7%
1/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
General disorders
Rectum pain
|
7.7%
1/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
General disorders
Flank pain
|
0.00%
0/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
10.0%
1/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
General disorders
Pain NOS
|
7.7%
1/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Respiratory, thoracic and mediastinal disorders
Pain in throat
|
0.00%
0/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
10.0%
1/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.7%
1/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
20.0%
2/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
33.3%
1/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
7.7%
1/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs
|
15.4%
2/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria
|
7.7%
1/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Respiratory, thoracic and mediastinal disorders
Congestion
|
0.00%
0/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
10.0%
1/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
10.0%
1/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Eye disorders
Dry eye
|
15.4%
2/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Eye disorders
Blurred vision
|
0.00%
0/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
33.3%
1/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Eye disorders
Eye lesion
|
7.7%
1/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Eye disorders
Eye irritation
|
0.00%
0/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
50.0%
1/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Eye disorders
Meibomian gland dysfunction
|
7.7%
1/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Eye disorders
Blepharitis
|
7.7%
1/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Eye disorders
Cloudy vision
|
7.7%
1/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Eye disorders
Eythema/conjunctive
|
7.7%
1/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Eye disorders
Conjunctivitis
|
7.7%
1/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Renal and urinary disorders
Urine color change
|
7.7%
1/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Renal and urinary disorders
Decreased GFR
|
7.7%
1/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
7.7%
1/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
Reproductive system and breast disorders
Vaginal dryness
|
7.7%
1/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
|
General disorders
Oral dysesthesia
|
7.7%
1/13 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/10 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/2 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
0.00%
0/3 • Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place