Trial Outcomes & Findings for Panitumumab Plus FOLFIRI in First-line Treatment of Metastatic Colorectal Cancer (NCT NCT00508404)
NCT ID: NCT00508404
Last Updated: 2019-11-19
Results Overview
Objective response rate is defined as the percentage of participants with a best response of complete response or partial response. Disease assessments are based on investigator review of scans using modified Response Evaluation Criteria in Solid Tumors (RECIST) V1.0 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 assessment 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 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
154 participants
Primary outcome timeframe
Tumor response was assessed at Week 8 and every 8 weeks to Week 48 and 3 monthly thereafter until disease progression; median follow-up time was 34 weeks
Results posted on
2019-11-19
Participant Flow
A total of 169 patients were screened, of whom 154 were enrolled into this study at 36 study centers in Austria, Belgium, France, Germany, and Sweden from 9 May 2007 through 18 June 2008. Results are reported through the primary analysis data cut-off date of 18 June 2009 (12 months after the last patient was enrolled).
Participants received a FOLFIRI regimen in combination with panitumumab once every 14 days until diagnosed with radiographic disease progression, at which time the participant was withdrawn from the treatment phase. Participants were to complete a safety follow-up visit 8 weeks after the treatment phase.
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 diagnosed with radiographic disease progression.
|
|---|---|
|
Overall Study
STARTED
|
154
|
|
Overall Study
COMPLETED
|
112
|
|
Overall Study
NOT COMPLETED
|
42
|
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 diagnosed with radiographic disease progression.
|
|---|---|
|
Overall Study
Ongoing at Data Cut-off
|
12
|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Death
|
16
|
|
Overall Study
Physician Decision
|
2
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Protocol-specified Criteria
|
2
|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Other - Not Specified
|
3
|
Baseline Characteristics
Panitumumab Plus FOLFIRI in First-line Treatment of Metastatic Colorectal Cancer
Baseline characteristics by cohort
| Measure |
Panitumumab Plus FOLFIRI
n=154 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 diagnosed with radiographic disease progression.
|
|---|---|
|
Age, Continuous
|
62.7 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
105 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White or Caucasian
|
150 participants
n=5 Participants
|
|
Kirsten Rat Sarcoma-2 Virus (KRAS) Mutation Status
Wild-type KRAS
|
86 participants
n=5 Participants
|
|
Kirsten Rat Sarcoma-2 Virus (KRAS) Mutation Status
Mutant KRAS
|
59 participants
n=5 Participants
|
|
Kirsten Rat Sarcoma-2 Virus (KRAS) Mutation Status
Unevaluable KRAS
|
9 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Tumor response was assessed at Week 8 and every 8 weeks to Week 48 and 3 monthly thereafter until disease progression; median follow-up time was 34 weeksPopulation: KRAS Tumor Response Analysis Set (all participants who provided informed consent, enrolled, received at least 1 dose of panitumumab, had evaluable KRAS status data, and with at least 1 unidimensionally measurable lesion per modified RECIST by 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 are based on investigator review of scans using modified Response Evaluation Criteria in Solid Tumors (RECIST) V1.0 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 assessment 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 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=85 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, until diagnosed with radiographic disease progression.
|
Mutant KRAS
n=58 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, until diagnosed with radiographic disease progression.
|
|---|---|---|
|
Objective Response Rate
|
56.47 percentage of participants
Interval 45.28 to 67.2
|
37.93 percentage of participants
Interval 25.51 to 51.63
|
SECONDARY outcome
Timeframe: Up to Week 17Population: KRAS Tumor Response Analysis Set
The percentage of participants with a best response of complete response or partial response by Week 17. Disease assessments are based on investigator review of scans using modified RECIST V1.0 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 assessment were considered non-responders.
Outcome measures
| Measure |
Wild-type KRAS
n=85 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, until diagnosed with radiographic disease progression.
|
Mutant KRAS
n=58 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, until diagnosed with radiographic disease progression.
|
|---|---|---|
|
Objective Response by 17 Weeks
|
49.41 percentage of participants
Interval 38.39 to 60.48
|
34.48 percentage of participants
Interval 22.49 to 48.12
|
SECONDARY outcome
Timeframe: Tumor response was assessed at Week 8 and every 8 weeks to Week 48 and 3 monthly thereafter until disease progression; median follow-up time was 34 weeksPopulation: KRAS 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 v1.0 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=85 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, until diagnosed with radiographic disease progression.
|
Mutant KRAS
n=58 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, until diagnosed with radiographic disease progression.
|
|---|---|---|
|
Disease Control Rate
|
90.59 percentage of participants
Interval 82.29 to 95.85
|
89.66 percentage of participants
Interval 78.83 to 96.11
|
SECONDARY outcome
Timeframe: Tumor response was assessed at Week 8 and every 8 weeks to Week 48 and 3 monthly thereafter until disease progression; median follow-up time was 34 weeks.Population: KRAS Tumor Response Analysis Set with an objective response (CR or PR)
Duration of response was calculated only for those participants who had a confirmed complete or partial response, and is defined as the time from first confirmed response to first observed progression. For participants who responded and did not progress by the analysis data cut-off date, duration of response was censored at their last evaluable disease assessment date. Duration of response was analyzed using the Kaplan-Meier method.
Outcome measures
| Measure |
Wild-type KRAS
n=48 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, until diagnosed with radiographic disease progression.
|
Mutant KRAS
n=22 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, until diagnosed with radiographic disease progression.
|
|---|---|---|
|
Duration of Response
|
13.0 months
Interval 9.3 to 13.0
|
7.4 months
Interval 5.4 to 8.8
|
SECONDARY outcome
Timeframe: Tumor response was assessed at Week 8 and every 8 weeks to Week 48 and 3 monthly thereafter until disease progression; median follow-up time was 34 weeks.Population: KRAS Tumor Response Analysis Set
Time to response is the time from the date of enrollment to the date of first confirmed complete or partial response. Participants with a best response of stable disease at the analysis data cut-off date were censored at their last assessment of SD and participants with all other categories of best response were censored at the maximum observed time to a first confirmed response among all responders. Time to initial objective response was analyzed using Kaplan-Meier methods.
Outcome measures
| Measure |
Wild-type KRAS
n=85 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, until diagnosed with radiographic disease progression.
|
Mutant KRAS
n=58 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, until diagnosed with radiographic disease progression.
|
|---|---|---|
|
Time to Initial Objective Response
|
3.8 months
Interval 3.4 to
Could not be estimated due to the low number of events.
|
NA months
Interval 5.5 to
Could not be estimated due to the low number of events.
|
SECONDARY outcome
Timeframe: From enrollment until the data cut-off date of 18 June 2009; median follow-up time was 34 weeks.Population: Primary Analysis Set (all participants who provided informed consent, enrolled, received at least 1 dose of panitumumab, and had evaluable KRAS status data)
Progression-free survival is the time from the date of enrollment to the date of first observed progression or death, whichever comes first. Participants who were alive and did not progress by the analysis data cut-off date were censored at the last evaluable disease assessment date. Progression-free survival was analyzed using Kaplan-Meier methods.
Outcome measures
| Measure |
Wild-type KRAS
n=86 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, until diagnosed with radiographic disease progression.
|
Mutant KRAS
n=59 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, until diagnosed with radiographic disease progression.
|
|---|---|---|
|
Progression-free Survival
|
8.9 months
Interval 7.6 to 14.3
|
7.2 months
Interval 5.6 to 7.8
|
SECONDARY outcome
Timeframe: From enrollment until the data cut-off date of 18 June 2009; median follow-up time was 34 weeks.Population: Primary Analysis Set
Time to progression is the time from the enrollment date to the date of first observed progression. For participants who had not progressed by the analysis data cutoff date, time to progressive disease was censored at their last evaluable disease assessment date. Time to disease progression was analyzed using Kaplan-Meier methods.
Outcome measures
| Measure |
Wild-type KRAS
n=86 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, until diagnosed with radiographic disease progression.
|
Mutant KRAS
n=59 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, until diagnosed with radiographic disease progression.
|
|---|---|---|
|
Time to Disease Progression
|
11.2 months
Interval 7.6 to 14.8
|
7.3 months
Interval 5.7 to 8.9
|
SECONDARY outcome
Timeframe: Tumor response was assessed at Week 8 and every 8 weeks to Week 48 and 3 monthly thereafter until disease progression; median follow-up time was 34 weeks.Population: KRAS Tumor Response Analysis Set with a best response of SD
Duration of stable disease was calculated only for participants with a best response of stable disease and is defined as the time from enrollment to first observed PD. For participants who did not progress by the analysis data cut-off date, duration of SD was censored at their last evaluable disease assessment date. Duration of stable disease was estimated using Kaplan-Meier methods.
Outcome measures
| Measure |
Wild-type KRAS
n=29 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, until diagnosed with radiographic disease progression.
|
Mutant KRAS
n=30 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, until diagnosed with radiographic disease progression.
|
|---|---|---|
|
Duration of Stable Disease
|
5.9 months
Interval 5.8 to 7.6
|
6.1 months
Interval 4.8 to 7.4
|
SECONDARY outcome
Timeframe: From enrollment until the data cut-off date of 18 June 2009; median follow-up time was 34 weeks.Population: Primary Analysis Set
Time to treatment failure is defined as the time from enrollment to the date the decision was made to end the treatment phase for any reason. For participants who remained in the treatment phase at the analysis data cut-off date, time to treatment failure was censored at the date of their last on-study assessment. Time to treatment failure was analyzed using Kaplan-Meier methods.
Outcome measures
| Measure |
Wild-type KRAS
n=86 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, until diagnosed with radiographic disease progression.
|
Mutant KRAS
n=59 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, until diagnosed with radiographic disease progression.
|
|---|---|---|
|
Time to Treatment Failure
|
6.9 months
Interval 6.2 to 7.6
|
5.8 months
Interval 5.3 to 6.8
|
SECONDARY outcome
Timeframe: From enrollment until the data cut-off date of 18 June 2009; median follow-up time was 34 weeks.Population: Primary Analysis Set participants who underwent surgery
Calculated only for those participants who underwent surgical intervention, and defined as the time from the date of first post-intervention radiographic disease assessment to the date of first observed PD. Participants with no post-intervention disease assessment had their time to relapse set to zero and censored in the analysis. Participants that had evidence of progression / recurrence at their first post-intervention disease assessment had a time to relapse of zero. For participants who had not progressed by the analysis data cut-off date, time to relapse was censored at the date of their last evaluable disease assessment. Time to relapse was analyzed using Kaplan-Meier metjhods.
Outcome measures
| Measure |
Wild-type KRAS
n=13 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, until diagnosed with radiographic disease progression.
|
Mutant KRAS
n=4 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, until diagnosed with radiographic disease progression.
|
|---|---|---|
|
Time to Disease Relapse Following Surgical Intervention
|
NA months
Could not be estimated due to the low number of events.
|
NA months
Could not be estimated due to the low number of events.
|
SECONDARY outcome
Timeframe: From enrollment until the data cut-off date of 18 June 2009; median follow-up time was 34 weeks.Population: Primary Analysis Set
The percentage of participants who underwent a surgical procedure that resulted in partial reduction or complete eradication of all metastatic disease.
Outcome measures
| Measure |
Wild-type KRAS
n=86 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, until diagnosed with radiographic disease progression.
|
Mutant KRAS
n=59 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, until diagnosed with radiographic disease progression.
|
|---|---|---|
|
Resection Rate
|
15.12 percentage of participants
Interval 8.3 to 24.46
|
6.78 percentage of participants
Interval 1.88 to 16.46
|
Adverse Events
Panitumumab Plus FOLFIRI
Serious events: 84 serious events
Other events: 154 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Panitumumab Plus FOLFIRI
n=154 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 diagnosed with radiographic disease progression.
|
|---|---|
|
Reproductive system and breast disorders
BENIGN PROSTATIC HYPERPLASIA
|
0.65%
1/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
ANAEMIA
|
1.3%
2/154 • 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 6.6 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
|
0.65%
1/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
0.65%
1/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
3.9%
6/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
MYOPERICARDITIS
|
0.65%
1/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
CONJUNCTIVITIS
|
0.65%
1/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
OCULAR TOXICITY
|
0.65%
1/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
0.65%
1/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
2.6%
4/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
ANAL FISSURE
|
0.65%
1/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.65%
1/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
DIARRHOEA
|
13.6%
21/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
DIARRHOEA HAEMORRHAGIC
|
0.65%
1/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
DYSPHAGIA
|
0.65%
1/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
FAECALOMA
|
0.65%
1/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
GASTROINTESTINAL INFLAMMATION
|
0.65%
1/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
HAEMATEMESIS
|
0.65%
1/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
ILEUS
|
1.9%
3/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
ILEUS PARALYTIC
|
1.3%
2/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
|
1.9%
3/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
INTESTINAL PERFORATION
|
0.65%
1/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
LARGE INTESTINE PERFORATION
|
0.65%
1/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
MELAENA
|
1.3%
2/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
NAUSEA
|
1.3%
2/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
RECTAL HAEMORRHAGE
|
1.3%
2/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
STOMATITIS
|
1.3%
2/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
SUBILEUS
|
1.3%
2/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
VOMITING
|
3.9%
6/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
CATHETER RELATED COMPLICATION
|
2.6%
4/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
CHEST PAIN
|
2.6%
4/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
CHILLS
|
0.65%
1/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
DEATH
|
1.3%
2/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
FATIGUE
|
3.2%
5/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
GENERAL PHYSICAL HEALTH DETERIORATION
|
1.9%
3/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
MUCOSAL INFLAMMATION
|
1.3%
2/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
MULTI-ORGAN FAILURE
|
0.65%
1/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
PYREXIA
|
3.2%
5/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
BILIARY DILATATION
|
0.65%
1/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.65%
1/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
CHOLESTASIS
|
0.65%
1/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
HEPATIC FAILURE
|
0.65%
1/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
HEPATIC LESION
|
0.65%
1/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
CATHETER RELATED INFECTION
|
2.6%
4/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
ERYSIPELAS
|
0.65%
1/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
GASTROENTERITIS
|
1.3%
2/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
HERPES SIMPLEX
|
0.65%
1/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
INFECTION
|
0.65%
1/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
INTERVERTEBRAL DISCITIS
|
0.65%
1/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
PARONYCHIA
|
1.3%
2/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
PERITONEAL ABSCESS
|
0.65%
1/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
PNEUMONIA
|
2.6%
4/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
SEPSIS
|
0.65%
1/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
SEPTIC SHOCK
|
0.65%
1/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
SINUSITIS
|
0.65%
1/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
SUBCUTANEOUS ABSCESS
|
0.65%
1/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
1.9%
3/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
UROSEPSIS
|
1.3%
2/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
FEMUR FRACTURE
|
0.65%
1/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
GASTROINTESTINAL STOMA COMPLICATION
|
0.65%
1/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
HUMERUS FRACTURE
|
0.65%
1/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
IATROGENIC INJURY
|
0.65%
1/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
SPINAL FRACTURE
|
0.65%
1/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
WEIGHT DECREASED
|
1.3%
2/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
3.2%
5/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
ELECTROLYTE IMBALANCE
|
0.65%
1/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
0.65%
1/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.65%
1/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
METABOLIC DISORDER
|
0.65%
1/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
PODAGRA
|
0.65%
1/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
0.65%
1/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
BURSITIS
|
0.65%
1/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
0.65%
1/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
OSTEOPOROTIC FRACTURE
|
0.65%
1/154 • 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 6.6 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)
COLORECTAL CANCER METASTATIC
|
1.3%
2/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
HEMIPARESIS
|
0.65%
1/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
INTRACRANIAL VENOUS SINUS THROMBOSIS
|
0.65%
1/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
ISCHAEMIC STROKE
|
0.65%
1/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
|
0.65%
1/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
VASCULITIS CEREBRAL
|
0.65%
1/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
HAEMATURIA
|
0.65%
1/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
HYDRONEPHROSIS
|
1.3%
2/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
PYELOCALIECTASIS
|
0.65%
1/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
RENAL COLIC
|
0.65%
1/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.65%
1/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Reproductive system and breast disorders
OVARIAN CYST
|
0.65%
1/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Reproductive system and breast disorders
PROSTATITIS
|
0.65%
1/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHOSPASM
|
0.65%
1/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
1.3%
2/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
LARYNGOSPASM
|
0.65%
1/154 • 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 6.6 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
|
7.1%
11/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY THROMBOSIS
|
0.65%
1/154 • 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 6.6 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
|
0.65%
1/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
0.65%
1/154 • 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 6.6 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
|
1.3%
2/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
CIRCULATORY COLLAPSE
|
0.65%
1/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
2.6%
4/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
HYPOTENSION
|
1.3%
2/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
PHLEBITIS
|
0.65%
1/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
THROMBOSIS
|
1.9%
3/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
VENA CAVA THROMBOSIS
|
1.3%
2/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Other adverse events
| Measure |
Panitumumab Plus FOLFIRI
n=154 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 diagnosed with radiographic disease progression.
|
|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
11.7%
18/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
5.2%
8/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
32.5%
50/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Ear and labyrinth disorders
VERTIGO
|
8.4%
13/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
CONJUNCTIVITIS
|
21.4%
33/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
DRY EYE
|
6.5%
10/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
LACRIMATION INCREASED
|
5.2%
8/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
20.1%
31/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
6.5%
10/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
APHTHOUS STOMATITIS
|
6.5%
10/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
CONSTIPATION
|
29.9%
46/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
DIARRHOEA
|
77.3%
119/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
11.7%
18/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
NAUSEA
|
55.2%
85/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
STOMATITIS
|
25.3%
39/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
VOMITING
|
26.6%
41/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
ASTHENIA
|
27.3%
42/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
CHEST PAIN
|
6.5%
10/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
FATIGUE
|
31.8%
49/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
MUCOSAL INFLAMMATION
|
26.0%
40/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
OEDEMA PERIPHERAL
|
11.7%
18/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
PAIN
|
6.5%
10/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
PYREXIA
|
12.3%
19/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
NASOPHARYNGITIS
|
7.1%
11/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
PARONYCHIA
|
24.0%
37/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
RHINITIS
|
6.5%
10/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
5.8%
9/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
WEIGHT DECREASED
|
13.6%
21/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
ANOREXIA
|
22.1%
34/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
22.7%
35/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
HYPOMAGNESAEMIA
|
18.8%
29/154 • 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 6.6 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
|
5.8%
9/154 • 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 6.6 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
|
5.8%
9/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
DYSGEUSIA
|
9.7%
15/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
HEADACHE
|
5.8%
9/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
PARAESTHESIA
|
5.8%
9/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
POLYNEUROPATHY
|
5.2%
8/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
DEPRESSION
|
5.2%
8/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
INSOMNIA
|
8.4%
13/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
7.8%
12/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
10.4%
16/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
11.7%
18/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
ACNE
|
35.7%
55/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
33.8%
52/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS
|
5.8%
9/154 • 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 6.6 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
|
20.8%
32/154 • 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 6.6 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
|
39.6%
61/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
10.4%
16/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
NAIL TOXICITY
|
5.8%
9/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME
|
16.2%
25/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
19.5%
30/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
RASH
|
41.6%
64/154 • 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 6.6 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
|
20.1%
31/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
SKIN TOXICITY
|
11.7%
18/154 • 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 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
HYPOTENSION
|
5.8%
9/154 • 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 6.6 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