Trial Outcomes & Findings for Panitumumab Regimen Evaluation in Colorectal Cancer to Estimate Primary Response to Treatment (NCT NCT00411450)
NCT ID: NCT00411450
Last Updated: 2016-02-15
Results Overview
Objective response rate is defined as the percentage of participants with a best response of complete response or partial response. Disease assessments were based on investigator review of scans using modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria. A complete or partial response was confirmed no less than 4 weeks after the criteria for response were first met. Participants with no radiographic tumor assessment(s) at Week 17 or 25 were considered non-responders. Complete Response (CR): disappearance of all target and non-target lesions and no new lesions. Partial Response (PR): At least a 30% decrease in the size of target lesions with no progression of non-target lesions (defined as a ≥ 25% increase in lesion size) and no new lesions, or, the disappearance of all target lesions but persistence of 1 or more non-target lesions not qualifying for either CR or progressive disease (PD) and no new lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
116 participants
Primary outcome timeframe
Week 17 and Week 25
Results posted on
2016-02-15
Participant Flow
This study was conducted at 56 sites in the United States. The first patient enrolled on 30 November 2006 and the last patient enrolled on 07 January 2008.
Participants recived second-line therapy until disease progression, intolerability, death, or study withdrawal. Participants completed a safety visit 4 weeks after the last dose. Participants were followed for survival every 12 weeks from the safety visit until the end of the study; the data cut-off date for results is 2 January 2009.
Participant milestones
| Measure |
Panitumumab Plus FOLFIRI
Participants received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until disease progression, intolerability, death, or study withdrawal.
|
|---|---|
|
Overall Study
STARTED
|
116
|
|
Overall Study
Received Treatment
|
115
|
|
Overall Study
COMPLETED
|
113
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Panitumumab Plus FOLFIRI
Participants received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until disease progression, intolerability, death, or study withdrawal.
|
|---|---|
|
Overall Study
Ongoing at time of data cut-off.
|
3
|
Baseline Characteristics
Panitumumab Regimen Evaluation in Colorectal Cancer to Estimate Primary Response to Treatment
Baseline characteristics by cohort
| Measure |
Panitumumab Plus FOLFIRI
n=116 Participants
Participants received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until disease progression, intolerability, death, or study withdrawal.
|
|---|---|
|
Age, Continuous
|
60.0 years
STANDARD_DEVIATION 12.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
75 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White or Caucasian
|
94 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
13 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
8 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
|
Kirsten Rat Sarcoma Gene (KRAS) Mutation Status
Wild-type
|
65 participants
n=5 Participants
|
|
Kirsten Rat Sarcoma Gene (KRAS) Mutation Status
Mutant
|
45 participants
n=5 Participants
|
|
Kirsten Rat Sarcoma Gene (KRAS) Mutation Status
Unevaluable
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 17 and Week 25Population: Tumor Response Analysis Set (all participants who provided informed consent prior to the initiation of any study specific procedures, received at least 1 dose of panitumumab, who had valid KRAS mutation status data available and with at least 1 uni-dimensionally measurable lesion per the local investigator)
Objective response rate is defined as the percentage of participants with a best response of complete response or partial response. Disease assessments were based on investigator review of scans using modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria. A complete or partial response was confirmed no less than 4 weeks after the criteria for response were first met. Participants with no radiographic tumor assessment(s) at Week 17 or 25 were considered non-responders. Complete Response (CR): disappearance of all target and non-target lesions and no new lesions. Partial Response (PR): At least a 30% decrease in the size of target lesions with no progression of non-target lesions (defined as a ≥ 25% increase in lesion size) and no new lesions, or, the disappearance of all target lesions but persistence of 1 or more non-target lesions not qualifying for either CR or progressive disease (PD) and no new lesions.
Outcome measures
| Measure |
Wild-type KRAS
n=64 Participants
Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
|
Mutant KRAS
n=43 Participants
Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
|
|---|---|---|
|
Objective Response Rate at Weeks 17 and 25
Week 17
|
20 percentage of participants
Interval 10.0 to 30.0
|
14 percentage of participants
Interval 4.0 to 24.0
|
|
Objective Response Rate at Weeks 17 and 25
Week 25
|
22 percentage of participants
Interval 12.0 to 32.0
|
14 percentage of participants
Interval 4.0 to 24.0
|
PRIMARY outcome
Timeframe: Tumor response was assessed at Weeks 9, 17, 25, and 33, and once every 12 weeks thereafter until the end of second-line treatment; maximum time on treatment was 77 weeks.Population: Tumor Response Analysis Set
Objective response rate is defined as the percentage of participants with a best response of complete response or partial response based on investigator review of scans using modified RECIST criteria. A complete or partial response was confirmed no less than 4 weeks after the criteria for response were first met. Participants with no post-baseline radiographic tumor assessment(s) were considered non-responders. CR: disappearance of all target and non-target lesions and no new lesions. PR: At least a 30% decrease in the size of target lesions with no progression of non-target lesions (defined as a ≥ 25% increase in lesion size) and no new lesions, or, the disappearance of all target lesions but persistence of 1 or more non-target lesions not qualifying for either CR or PD and no new lesions.
Outcome measures
| Measure |
Wild-type KRAS
n=64 Participants
Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
|
Mutant KRAS
n=43 Participants
Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
|
|---|---|---|
|
Best Response During Second-Line Treatment
|
23 percentage of participants
Interval 13.0 to 34.0
|
16 percentage of participants
Interval 5.0 to 27.0
|
PRIMARY outcome
Timeframe: Week 17 and Week 25Population: Primary Analysis Set (all participants who provided informed consent prior to the initiation of any study specific procedures, received at least 1 dose of panitumumab, and who had valid KRAS mutation status data available)
The progression-free survival rate is defined as the Kaplan-Meier (KM) estimator of progression-free survival at Week 17 and Week 25 reported as the probability of being event (disease progression or death)-free. Tumor assessments were evaluated by the investigator according to modified RECIST criteria. PD: At least a 20% increase in the size of target lesions since the treatment started or at least a 25% increase in the size of non-target lesions and the lesion(s) measure ≥ 10 mm, or the appearance of any new lesions. Participants who withdraw from the study prior to completion of Week 17 or 25 radiographic tumor assessments were censored at the last evaluable tumor assessment.
Outcome measures
| Measure |
Wild-type KRAS
n=64 Participants
Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
|
Mutant KRAS
n=45 Participants
Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
|
|---|---|---|
|
Progression-free Survival Rate at Weeks 17 and 25
Week 17
|
67 percent probability
Interval 54.0 to 77.0
|
55 percent probability
Interval 39.0 to 68.0
|
|
Progression-free Survival Rate at Weeks 17 and 25
Week 25
|
52 percent probability
Interval 39.0 to 64.0
|
41 percent probability
Interval 27.0 to 55.0
|
PRIMARY outcome
Timeframe: From Study Day 1 until the data cut-off date of 2 January 2009; median follow-up time was 39 weeks, with a maximum of 93 weeks.Population: Primary Analysis Set
Progression-free survival time was defined as the time from Study Day 1 to the date of disease progression (based on investigator assessment) or the date of death due to any cause. Participants who terminated from the study early (eg, prior to disease progression due to fully withdrawn informed consent) were censored at their last tumor assessment.
Outcome measures
| Measure |
Wild-type KRAS
n=64 Participants
Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
|
Mutant KRAS
n=45 Participants
Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
|
|---|---|---|
|
Progression-free Survival Time
|
26 weeks
Interval 19.0 to 33.0
|
19 weeks
Interval 12.0 to 25.0
|
PRIMARY outcome
Timeframe: Week 17 and Week 25Population: Tumor Response Analysis Set
The percentage of participants whose best response was either a complete or partial response or stable disease, based on modified RECIST criteria as assessed by the investigator. Stable diease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD of target lesions and no progression of existing non-target lesions and no new lesions, or, the persistence of 1 or more non-target lesions not qualifying for either CR or PD if no target lesions were identified at Baseline.
Outcome measures
| Measure |
Wild-type KRAS
n=64 Participants
Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
|
Mutant KRAS
n=43 Participants
Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
|
|---|---|---|
|
Disease Control Rate at Weeks 17 and 25
Week 17
|
64 percentage of participants
Interval 52.0 to 76.0
|
58 percentage of participants
Interval 43.0 to 73.0
|
|
Disease Control Rate at Weeks 17 and 25
Week 25
|
64 percentage of participants
Interval 52.0 to 76.0
|
58 percentage of participants
Interval 43.0 to 73.0
|
PRIMARY outcome
Timeframe: Tumor response was assessed at Weeks 9, 17, 25, and 33, and once every 12 weeks thereafter until the end of second-line treatment; maximum time on treatment was 77 weeks.Population: Responders of Tumor Response Analysis Set
Duration of response is defined as the time from the date of first response to the date of first progression of disease during second-line treatment (as evaluated by the investigator) or death (if the death was due to disease progression but not detected earlier) in the subset of participants who responded (CR or PR, as evaluated by the investigator). Duration of response was analyzed using Kaplan-Meier methods; participants who responded but did not progress while on study were censored at the date of last tumor assessment.
Outcome measures
| Measure |
Wild-type KRAS
n=15 Participants
Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
|
Mutant KRAS
n=7 Participants
Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
|
|---|---|---|
|
Duration of Response
|
29 weeks
Interval 21.0 to 39.0
|
23 weeks
Interval 16.0 to 74.0
|
PRIMARY outcome
Timeframe: From Study Day 1 until the data cut-off date of 2 January 2009; median follow-up time was 39 weeks, with a maximum of 93 weeks.Population: Primary Analysis Set
Overall survival is defined as as the number of days from Study Day 1 to the date of death due to any cause. Overall survival was analyzed using the Kaplan-Meier method; participants who were lost to follow-up or who had not died at the end of the study (52 weeks after the last participant was enrolled) were censored at the date of last contact.
Outcome measures
| Measure |
Wild-type KRAS
n=64 Participants
Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
|
Mutant KRAS
n=45 Participants
Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
|
|---|---|---|
|
Overall Survival
|
50 weeks
Interval 39.0 to 76.0
|
31 weeks
Interval 23.0 to 47.0
|
PRIMARY outcome
Timeframe: Tumor response was assessed at Weeks 9, 17, 25, and 33, and once every 12 weeks thereafter until the end of second-line treatment; maximum time on treatment was 77 weeks.Population: Primary Analysis Set
Time to failure of second-line treatment is defined as the time from study Day 1 to the date of the earliest of the following events: end of second-line therapy due to any reason except for complete response and curative surgery; progressive disease; or death due to any cause. Time to treatment failure was analyzed using Kaplan-Meier methods; participants who did not discontinue second-line treatment or discontinue due to complete response or curative surgery, who were still alive, and who did not have disease progression were censored at the date of the last contact.
Outcome measures
| Measure |
Wild-type KRAS
n=64 Participants
Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
|
Mutant KRAS
n=45 Participants
Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
|
|---|---|---|
|
Time to Treatment Failure
|
19 weeks
Interval 14.0 to 25.0
|
15 weeks
Interval 8.0 to 19.0
|
PRIMARY outcome
Timeframe: From Study Day 1 until the data cut-off date of 2 January 2009; median follow-up time was 39 weeks, with a maximum of 93 weeks.Population: Primary Analysis Set
Time to progression is defined as the time from study Day 1 to the date of observed disease progression. Time to progression was analyzed using Kaplan-Meier methods; participants who did not have disease progression were censored at the date of last evaluable tumor assessment.
Outcome measures
| Measure |
Wild-type KRAS
n=64 Participants
Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
|
Mutant KRAS
n=45 Participants
Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
|
|---|---|---|
|
Time to Progression
|
26 weeks
Interval 16.0 to 34.0
|
17 weeks
Interval 15.0 to 25.0
|
PRIMARY outcome
Timeframe: Tumor response was assessed at Weeks 9, 17, 25, and 33, and once every 12 weeks thereafter until the end of second-line treatment; maximum time on treatment was 77 weeks.Population: Responders in the Tumor Response Analysis Set
Time to response of second-line treatment is defined as the time from study Day 1 to the date of first documentation of CR or PR, calculated for those participants with an objective tumor response of CR or PR.
Outcome measures
| Measure |
Wild-type KRAS
n=15 Participants
Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
|
Mutant KRAS
n=7 Participants
Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
|
|---|---|---|
|
Time to Response
|
9.1 weeks
Interval 6.9 to 32.3
|
9.3 weeks
Interval 7.0 to 35.6
|
SECONDARY outcome
Timeframe: From the first dose date to 30 days after the last dose date. The median time frame is 4.5 months.Population: Safety analysis set (all participants who provided informed consent prior to the initiation of any study specific procedure and who received at least 1 dose of panitumumab)
The severity of adverse events (AEs) was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, except for panitumumab related skin toxicities, where 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. The relationship of each adverse event to the panitumumab and/or FOLFIRI regimen was assessed by the investigator. A serious adverse event was defined as an adverse event that • is fatal • is life threatening • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect • other significant medical hazard.
Outcome measures
| Measure |
Wild-type KRAS
n=115 Participants
Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
|
Mutant KRAS
Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
|
|---|---|---|
|
Number of Participants With Adverse Events
Any adverse event
|
115 participants
|
—
|
|
Number of Participants With Adverse Events
Grade 3 or higher adverse event
|
94 participants
|
—
|
|
Number of Participants With Adverse Events
Panitumumab-related adverse events
|
107 participants
|
—
|
|
Number of Participants With Adverse Events
Chemotherapy-related adverse events
|
112 participants
|
—
|
|
Number of Participants With Adverse Events
≥ grade 3 panitumumab-related adverse events
|
56 participants
|
—
|
|
Number of Participants With Adverse Events
≥ grade 3 chemotherapy-related adverse events
|
65 participants
|
—
|
|
Number of Participants With Adverse Events
Serious adverse events
|
46 participants
|
—
|
|
Number of Participants With Adverse Events
Serious panitumumab-related adverse events
|
15 participants
|
—
|
|
Number of Participants With Adverse Events
Serious chemotherapy-related adverse events
|
24 participants
|
—
|
|
Number of Participants With Adverse Events
Life-threatening adverse events
|
18 participants
|
—
|
|
Number of Participants With Adverse Events
Ended second-line treatment due to adverse events
|
18 participants
|
—
|
|
Number of Participants With Adverse Events
Ended panitumumab due to adverse events
|
20 participants
|
—
|
|
Number of Participants With Adverse Events
Ended FOLFIRI due to adverse events
|
28 participants
|
—
|
|
Number of Participants With Adverse Events
Death due to adverse events
|
8 participants
|
—
|
|
Number of Participants With Adverse Events
Panitumumab infusion reactions
|
2 participants
|
—
|
|
Number of Participants With Adverse Events
Deaths during study
|
71 participants
|
—
|
SECONDARY outcome
Timeframe: From the first dose date to 30 days after the last dose date. The median time frame is 4.5 months.Population: Safety Analysis Set
Laboratory toxicities were graded according to CTCAE version 3.
Outcome measures
| Measure |
Wild-type KRAS
n=115 Participants
Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
|
Mutant KRAS
Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
|
|---|---|---|
|
Number of Participants With Grade 4 Laboratory Toxicities
Anemia
|
1 participants
|
—
|
|
Number of Participants With Grade 4 Laboratory Toxicities
Neutropenia
|
4 participants
|
—
|
|
Number of Participants With Grade 4 Laboratory Toxicities
Hypomagnesaemia
|
8 participants
|
—
|
|
Number of Participants With Grade 4 Laboratory Toxicities
Hypokalemia
|
1 participants
|
—
|
|
Number of Participants With Grade 4 Laboratory Toxicities
Hypocalcaemia
|
3 participants
|
—
|
|
Number of Participants With Grade 4 Laboratory Toxicities
Hyperbilirubinaemia
|
1 participants
|
—
|
SECONDARY outcome
Timeframe: Prior to first dose and 28 days after the last dose of second-line treatmentPopulation: Safety Analysis Set with baseline anti-panitumumab antibody testing sample available
The immunogenicity of panitumumab was evaluated using 2 different screening immunoassays for the detection of anti-panitumumab antibodies: an acid dissociation bridging enzyme-linked immunosorbent assay (ELISA; detecting high-affinity antibodies) and a Biacore® biosensor immunoassay (detecting both high and low-affinity antibodies). When either of the 2 screening assays yielded a positive result, that particular sample was subjected to an in vitro bioassay for the detection of neutralizing antibodies.
Outcome measures
| Measure |
Wild-type KRAS
n=113 Participants
Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
|
Mutant KRAS
Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
|
|---|---|---|
|
Number of Participants Who Developed Antibodies to Panitumumab
Binding antibody positive
|
1 participants
|
—
|
|
Number of Participants Who Developed Antibodies to Panitumumab
Neutralizing antibody positive
|
0 participants
|
—
|
Adverse Events
Panitumumab + FOLFIRI
Serious events: 46 serious events
Other events: 114 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Panitumumab + FOLFIRI
n=115 participants at risk
Participants received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until disease progression, intolerability, death, or study withdrawal.
|
|---|---|
|
Psychiatric disorders
Mental status changes
|
0.87%
1/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.87%
1/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Renal failure
|
0.87%
1/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Renal failure acute
|
1.7%
2/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.87%
1/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.87%
1/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
1.7%
2/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.87%
1/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Amnesia
|
0.87%
1/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.87%
1/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Headache
|
0.87%
1/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Sedation
|
0.87%
1/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.87%
1/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Syncope
|
2.6%
3/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Anxiety
|
0.87%
1/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.7%
2/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.7%
2/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Neutropenia
|
3.5%
4/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
1.7%
2/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.7%
2/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Atrial fibrillation
|
0.87%
1/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Atrial tachycardia
|
0.87%
1/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Cardiac arrest
|
0.87%
1/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Pericardial effusion
|
0.87%
1/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.87%
1/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Endocrine disorders
Adrenocortical insufficiency acute
|
0.87%
1/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.7%
2/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Ascites
|
0.87%
1/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Constipation
|
0.87%
1/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.6%
3/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Ileus
|
0.87%
1/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
1.7%
2/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Nausea
|
1.7%
2/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.87%
1/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Vomiting
|
1.7%
2/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Asthenia
|
2.6%
3/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Gait disturbance
|
0.87%
1/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Mucosal inflammation
|
3.5%
4/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Non-cardiac chest pain
|
0.87%
1/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Pain
|
0.87%
1/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Pyrexia
|
5.2%
6/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.87%
1/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Abdominal abscess
|
0.87%
1/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.87%
1/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Infection
|
0.87%
1/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Lobar pneumonia
|
0.87%
1/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Neutropenic sepsis
|
0.87%
1/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Perirectal abscess
|
0.87%
1/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pneumonia
|
0.87%
1/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Sepsis
|
3.5%
4/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.87%
1/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Urinary tract infection
|
0.87%
1/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.87%
1/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Dehydration
|
10.4%
12/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
1.7%
2/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.87%
1/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.87%
1/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.7%
2/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
1.7%
2/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.87%
1/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.87%
1/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Hallucination
|
0.87%
1/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.87%
1/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
3.5%
4/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.87%
1/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.87%
1/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Deep vein thrombosis
|
3.5%
4/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Hypotension
|
0.87%
1/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Orthostatic hypotension
|
0.87%
1/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Other adverse events
| Measure |
Panitumumab + FOLFIRI
n=115 participants at risk
Participants received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until disease progression, intolerability, death, or study withdrawal.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
26.1%
30/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Neutropenia
|
28.7%
33/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.2%
6/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Conjunctivitis
|
5.2%
6/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Lacrimation increased
|
6.1%
7/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Vision blurred
|
6.1%
7/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Abdominal pain
|
25.2%
29/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.1%
7/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Constipation
|
22.6%
26/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Diarrhoea
|
73.9%
85/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Dry mouth
|
5.2%
6/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.8%
9/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Nausea
|
55.7%
64/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Stomatitis
|
28.7%
33/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Vomiting
|
29.6%
34/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Asthenia
|
10.4%
12/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Catheter thrombosis
|
5.2%
6/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Fatigue
|
53.0%
61/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Mucosal inflammation
|
33.0%
38/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Oedema peripheral
|
20.9%
24/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Pain
|
8.7%
10/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Pyrexia
|
18.3%
21/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Paronychia
|
8.7%
10/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.1%
7/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Urinary tract infection
|
8.7%
10/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
International normalised ratio increased
|
5.2%
6/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Neutrophil count decreased
|
5.2%
6/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Weight decreased
|
24.3%
28/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Anorexia
|
33.0%
38/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
8.7%
10/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Dehydration
|
18.3%
21/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
19.1%
22/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
20.0%
23/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.1%
7/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.5%
19/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
5.2%
6/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
7.0%
8/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.6%
11/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Dizziness
|
17.4%
20/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Dysgeusia
|
13.0%
15/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Headache
|
5.2%
6/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Neuropathy peripheral
|
6.1%
7/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Anxiety
|
11.3%
13/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Depression
|
7.0%
8/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Insomnia
|
7.8%
9/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.2%
14/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.0%
8/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
9.6%
11/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
7.8%
9/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
27.8%
32/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
38.3%
44/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
24.3%
28/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
6.1%
7/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
6.1%
7/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
20.9%
24/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Rash
|
52.2%
60/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
14.8%
17/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Hypotension
|
12.2%
14/115 • The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Additional Information
Study Director
Amgen Inc.
Phone: 866-572-6436
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER