Trial Outcomes & Findings for Evaluating Panitumumab (ABX-EGF) in Patients With Metastatic Colorectal Cancer (NCT NCT00111761)

Last Updated: 2013-12-12

Results Overview

The number of participants with grade 3 or grade 4 diarrhea in Part 2 of the study. Grading of diarrhea followed the grading scale in Version 2.0 of the National Cancer Institute Common Toxicity Criteria (NCI CTC).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

43 participants

Primary outcome timeframe

Until disease progression (median 47 weeks)

Results posted on

2013-12-12

Participant Flow

Participants were enrolled from 19 Jul 2002 through 20 April 2004

Participant milestones

Participant milestones
Measure	Panitumumab With FOLFIRI Panitumumab (2.5 mg/kg once weekly until disease progression, intolerable adverse event or other reason for discontinuation) in combination with irinotecan/5-FU/leucovorin chemotherapy (the FOLFIRI regimen)	Panitumumab With IFL Panitumumab (2.5 mg/kg once weekly for up to 48 weeks or until disease progression, intolerable adverse event or other reason for discontinuation) in combination with irinotecan, 5-fluorouracil and leucovorin (IFL chemotherapy regimen)
Part 1 STARTED	0	19
Part 1 COMPLETED	0	14
Part 1 NOT COMPLETED	0	5
Part 2 STARTED	24	0
Part 2 COMPLETED	16	0
Part 2 NOT COMPLETED	8	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Panitumumab With FOLFIRI Panitumumab (2.5 mg/kg once weekly until disease progression, intolerable adverse event or other reason for discontinuation) in combination with irinotecan/5-FU/leucovorin chemotherapy (the FOLFIRI regimen)	Panitumumab With IFL Panitumumab (2.5 mg/kg once weekly for up to 48 weeks or until disease progression, intolerable adverse event or other reason for discontinuation) in combination with irinotecan, 5-fluorouracil and leucovorin (IFL chemotherapy regimen)
Part 1 Physician Decision	0	1
Part 1 Death	0	2
Part 1 Other	0	1
Part 1 Withdrawal by Subject	0	1
Part 2 Adverse Event	1	0
Part 2 Physician Decision	1	0
Part 2 Death	1	0
Part 2 Disease progression	3	0
Part 2 Protocol-specified criteria	1	0
Part 2 Other	1	0

Baseline Characteristics

Evaluating Panitumumab (ABX-EGF) in Patients With Metastatic Colorectal Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Panitumumab With IFL n=19 Participants Panitumumab in combination with irinotecan, 5-fluorouracil and leucovorin (IFL chemotherapy regimen)	Panitumumab With FOLFIRI n=24 Participants Panitumumab in combination with irinotecan/5-FU/leucovorin chemotherapy (the FOLFIRI regimen)	Total n=43 Participants Total of all reporting groups
Age Continuous	56.6 Years STANDARD_DEVIATION 12.1 • n=5 Participants	60.7 Years STANDARD_DEVIATION 15.0 • n=7 Participants	58.9 Years STANDARD_DEVIATION 13.8 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	10 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	14 Participants n=7 Participants	30 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized White or Caucasian	13 Participants n=5 Participants	18 Participants n=7 Participants	31 Participants n=5 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Until disease progression (median 47 weeks)

Population: Subjects Treated Analysis Set, composed of participants who received at least one dose of panitumumab or one dose of chemotherapy.

Outcome measures

Outcome measures
Measure	Panitumumab With FOLFIRI n=24 Participants Panitumumab in combination with irinotecan/5-FU/leucovorin chemotherapy (the FOLFIRI regimen)
Number of Participants With Grade 3 or Grade 4 Diarrhea (Part 2)	6 Participants

PRIMARY outcome

Timeframe: Until disease progression (median 35 weeks) or 48 weeks, whichever occurred first

Population: Subjects Treated Analysis Set, composed of all consented participants who received at least 1 dose of panitumumab and at least 1 dose of chemotherapy.

The number of participants with grade 3 or grade 4 diarrhea in Part 1 of the study. Grading of diarrhea followed the grading scale in Version 2.0 of the National Cancer Institute Common Toxicity Criteria (NCI CTC).

Outcome measures

Outcome measures
Measure	Panitumumab With FOLFIRI n=19 Participants Panitumumab in combination with irinotecan/5-FU/leucovorin chemotherapy (the FOLFIRI regimen)
Number of Participants With Grade 3 or Grade 4 Diarrhea (Part 1)	11 Participants

SECONDARY outcome

Timeframe: Until disease progression (median 47 weeks)

Population: Subjects Treated Analysis Set, composed of participants who received at least one dose of panitumumab or one dose of chemotherapy

Objective tumor response (complete or partial) in Part 2 of the study, based on Response Evaluation Criteria in Solid Tumors (RECIST), where complete response = disappearance of all target lesions, partial response = ≥30% reduction in lesion size, progressive disease = ≥20% increase in tumor size; otherwise stable disease.

Outcome measures

Outcome measures
Measure	Panitumumab With FOLFIRI n=24 Participants Panitumumab in combination with irinotecan/5-FU/leucovorin chemotherapy (the FOLFIRI regimen)
Number of Participants With an Objective Tumor Response (Part 2)	8 Participants

SECONDARY outcome

Timeframe: From enrollment until death or diease progression. Maximum follow-up time was 16 months.

Population: Subjects Treated Analysis Set, composed of participants who received at least one dose of panitumumab or one dose of chemotherapy

Kaplan-Meier estimate of median time from the first dose of study drug to first observed disease progression or death if the death was due to disease progression (whichever comes first) in Part 2 of the study. Participants who had not progressed or died for reasons other than disease progression were censored at their last disease assessment date.

Outcome measures

Outcome measures
Measure	Panitumumab With FOLFIRI n=24 Participants Panitumumab in combination with irinotecan/5-FU/leucovorin chemotherapy (the FOLFIRI regimen)
Time to Disease Progression (Part 2)	47.3 weeks Interval 26.0 to Could not be estimated due to the low number of events.

SECONDARY outcome

Timeframe: From enrollment until disease progression or death. Maximum follow-up time was 16 months.

Population: Subjects Treated Analysis Set, composed of participants who received at least one dose of panitumumab or one dose of chemotherapy

Kaplan-Meier estimate of median time from enrollment to death or disease progression in Part 2 of the study. Participants who had not progressed and had not died were censored at their last disease assessment date.

Outcome measures

Outcome measures
Measure	Panitumumab With FOLFIRI n=24 Participants Panitumumab in combination with irinotecan/5-FU/leucovorin chemotherapy (the FOLFIRI regimen)
Progression-free Survival Time (Part 2)	41.1 weeks Interval 26.0 to Could not be estimated due to the low number of events.

SECONDARY outcome

Timeframe: From enrollment until death. Maximum follow-up time was 16 months.

Population: Subjects Treated Analysis Set, composed of all consented participants who received at least 1 dose of panitumumab and at least 1 dose of chemotherapy.

Kaplan-Meier estimate of the median time from enrollment to death from any cause. Participants who did not die on study were censored at their last contact date.

Outcome measures

Outcome measures
Measure	Panitumumab With FOLFIRI n=19 Participants Panitumumab in combination with irinotecan/5-FU/leucovorin chemotherapy (the FOLFIRI regimen)
Survival Time (Part 2)	73.1 weeks Interval 59.4 to Could not be estimated due to the low number of events.

SECONDARY outcome

Timeframe: From enrollment until last contact. Maximum follow-up was 16 months.

Population: Subjects Treated Analysis Set, composed of participants who received at least one dose of panitumumab or one dose of chemotherapy

The number of participants in Part 2 who died during the study.

Outcome measures

Outcome measures
Measure	Panitumumab With FOLFIRI n=24 Participants Panitumumab in combination with irinotecan/5-FU/leucovorin chemotherapy (the FOLFIRI regimen)
Number of Participants Who Died (Part 2)	6 participants

SECONDARY outcome

Timeframe: Until disease progression (median 35 weeks) or 48 weeks, whichever occurred first

Population: Subjects Treated Analysis Set, composed of all consented participants who received at least 1 dose of panitumumab and at least 1 dose of chemotherapy.

Objective tumor response (complete or partial) in Part 1 of the study, based on Response Evaluation Criteria in Solid Tumors (RECIST), where complete response = disappearance of all target lesions, partial response = ≥30% reduction in lesion size, progressive disease = ≥20% increase in tumor size; otherwise stable disease.

Outcome measures

Outcome measures
Measure	Panitumumab With FOLFIRI n=19 Participants Panitumumab in combination with irinotecan/5-FU/leucovorin chemotherapy (the FOLFIRI regimen)
Number of Participants With Objective Tumor Response (Part 1)	9 Participants

SECONDARY outcome

Timeframe: From enrollment until disease progression or death. Maximum follow-up time was 25 months.

Population: Subjects Treated Analysis Set, composed of all consented participants who received at least 1 dose of panitumumab and at least 1 dose of chemotherapy.

Kaplan-Meier estimate of median time from enrollment to death or disease progression in Part 1 of the study. Participants who had not progressed and had not died were censored at their last disease assessment date.

Outcome measures

Outcome measures
Measure	Panitumumab With FOLFIRI n=19 Participants Panitumumab in combination with irinotecan/5-FU/leucovorin chemotherapy (the FOLFIRI regimen)
Progression-free Survival Time (Part 1)	24.3 weeks Interval 19.0 to 36.0

SECONDARY outcome

Timeframe: From enrollment until disease progression or death. Maximum follow-up time was 25 months.

Population: Subjects Treated Analysis Set, composed of all consented participants who received at least 1 dose of panitumumab and at least 1 dose of chemotherapy.

Kaplan-Meier estimate of the median time from the first dose of study drug to disease progression or death if due to disease progression (whichever comes first) in Part 1 of the study. Participants who had not progressed or died for reasons other than disease progression were censored at their last disease assessment date.

Outcome measures

Outcome measures
Measure	Panitumumab With FOLFIRI n=19 Participants Panitumumab in combination with irinotecan/5-FU/leucovorin chemotherapy (the FOLFIRI regimen)
Time to Disease Progression (Part 1)	35.0 weeks Interval 21.7 to 72.0

SECONDARY outcome

Timeframe: From enrollment until death. Maximum follow-up time was 25 months.

Population: Subjects Treated Analysis Set, composed of all consented participants who received at least 1 dose of panitumumab and at least 1 dose of chemotherapy.

Kaplan-Meier estimate of the median time from enrollment to death from any cause. Participants who did not die on study were censored at their last contact date.

Outcome measures

Outcome measures
Measure	Panitumumab With FOLFIRI n=19 Participants Panitumumab in combination with irinotecan/5-FU/leucovorin chemotherapy (the FOLFIRI regimen)
Survival Time (Part 1)	73.1 weeks Interval 59.4 to Could not be estimated due to the low number of events.

SECONDARY outcome

Timeframe: Until disease progression (median 35 weeks) or 48 weeks, whichever occurred first

Population: Subjects Treated Analysis Set, composed of all consented participants who received at least 1 dose of panitumumab and at least 1 dose of chemotherapy.

Kaplan-Meier estimate of the median time from the date of first dose of panitumumab or chemotherapy to the date the decision was made to end treatment for any reason in Part 1 of the study.

Outcome measures

Outcome measures
Measure	Panitumumab With FOLFIRI n=19 Participants Panitumumab in combination with irinotecan/5-FU/leucovorin chemotherapy (the FOLFIRI regimen)
Time to Treatment Failure (Part 1)	24.3 Weeks Interval 7.9 to 36.0

SECONDARY outcome

Timeframe: Until disease progression (median 35 weeks) or 48 weeks, whichever occurred first

Population: Subset of Subjects Treated Analysis Set, composed of all consented participants who received at least 1 dose of panitumumab and at least 1 dose of chemotherapy, who had an objective tumor response.

Median time to first observed objective tumor response (complete or partial) among responders in Part 1 of the study.

Outcome measures

Outcome measures
Measure	Panitumumab With FOLFIRI n=9 Participants Panitumumab in combination with irinotecan/5-FU/leucovorin chemotherapy (the FOLFIRI regimen)
Time to Initial Objective Tumor Response (Part 1)	5.9 weeks Interval 5.4 to 11.3

Adverse Events

Panitumumab Plus IFL

Serious events: 12 serious events

Other events: 19 other events

Deaths: 0 deaths

Panitumumab Plus FOLFIRI

Serious events: 11 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

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 aftercompletion. 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

Measure	Panitumumab Plus IFL n=19 participants at risk	Panitumumab Plus FOLFIRI n=24 participants at risk
Blood and lymphatic system disorders Febrile neutropenia	10.5% 2/19 • First dose through maximum of safety FU or 30 days after last dose (median 47 weeks follow-up) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/24 • First dose through maximum of safety FU or 30 days after last dose (median 47 weeks follow-up) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Cardiac failure congestive	0.00% 0/19 • First dose through maximum of safety FU or 30 days after last dose (median 47 weeks follow-up) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.2% 1/24 • First dose through maximum of safety FU or 30 days after last dose (median 47 weeks follow-up) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Abdominal pain	10.5% 2/19 • First dose through maximum of safety FU or 30 days after last dose (median 47 weeks follow-up) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/24 • First dose through maximum of safety FU or 30 days after last dose (median 47 weeks follow-up) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Diarrhoea	42.1% 8/19 • First dose through maximum of safety FU or 30 days after last dose (median 47 weeks follow-up) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.2% 1/24 • First dose through maximum of safety FU or 30 days after last dose (median 47 weeks follow-up) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/19 • First dose through maximum of safety FU or 30 days after last dose (median 47 weeks follow-up) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.2% 1/24 • First dose through maximum of safety FU or 30 days after last dose (median 47 weeks follow-up) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Ileus paralytic	5.3% 1/19 • First dose through maximum of safety FU or 30 days after last dose (median 47 weeks follow-up) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/24 • First dose through maximum of safety FU or 30 days after last dose (median 47 weeks follow-up) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Intestinal fistula	0.00% 0/19 • First dose through maximum of safety FU or 30 days after last dose (median 47 weeks follow-up) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.2% 1/24 • First dose through maximum of safety FU or 30 days after last dose (median 47 weeks follow-up) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Rectal haemorrhage	5.3% 1/19 • First dose through maximum of safety FU or 30 days after last dose (median 47 weeks follow-up) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/24 • First dose through maximum of safety FU or 30 days after last dose (median 47 weeks follow-up) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Small intestinal obstruction	5.3% 1/19 • First dose through maximum of safety FU or 30 days after last dose (median 47 weeks follow-up) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/24 • First dose through maximum of safety FU or 30 days after last dose (median 47 weeks follow-up) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	5.3% 1/19 • First dose through maximum of safety FU or 30 days after last dose (median 47 weeks follow-up) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/24 • First dose through maximum of safety FU or 30 days after last dose (median 47 weeks follow-up) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Chest pain	0.00% 0/19 • First dose through maximum of safety FU or 30 days after last dose (median 47 weeks follow-up) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	8.3% 2/24 • First dose through maximum of safety FU or 30 days after last dose (median 47 weeks follow-up) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Chills	0.00% 0/19 • First dose through maximum of safety FU or 30 days after last dose (median 47 weeks follow-up) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.2% 1/24 • First dose through maximum of safety FU or 30 days after last dose (median 47 weeks follow-up) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Mucosal inflammation	0.00% 0/19 • First dose through maximum of safety FU or 30 days after last dose (median 47 weeks follow-up) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.2% 1/24 • First dose through maximum of safety FU or 30 days after last dose (median 47 weeks follow-up) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Pyrexia	5.3% 1/19 • First dose through maximum of safety FU or 30 days after last dose (median 47 weeks follow-up) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.2% 1/24 • First dose through maximum of safety FU or 30 days after last dose (median 47 weeks follow-up) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Abdominal abscess	0.00% 0/19 • First dose through maximum of safety FU or 30 days after last dose (median 47 weeks follow-up) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.2% 1/24 • First dose through maximum of safety FU or 30 days after last dose (median 47 weeks follow-up) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Bacteraemia	0.00% 0/19 • First dose through maximum of safety FU or 30 days after last dose (median 47 weeks follow-up) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.2% 1/24 • First dose through maximum of safety FU or 30 days after last dose (median 47 weeks follow-up) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Catheter related infection	0.00% 0/19 • First dose through maximum of safety FU or 30 days after last dose (median 47 weeks follow-up) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.2% 1/24 • First dose through maximum of safety FU or 30 days after last dose (median 47 weeks follow-up) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Cellulitis	0.00% 0/19 • First dose through maximum of safety FU or 30 days after last dose (median 47 weeks follow-up) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	8.3% 2/24 • First dose through maximum of safety FU or 30 days after last dose (median 47 weeks follow-up) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Sepsis	0.00% 0/19 • First dose through maximum of safety FU or 30 days after last dose (median 47 weeks follow-up) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	8.3% 2/24 • First dose through maximum of safety FU or 30 days after last dose (median 47 weeks follow-up) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Staphylococcal sepsis	0.00% 0/19 • First dose through maximum of safety FU or 30 days after last dose (median 47 weeks follow-up) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.2% 1/24 • First dose through maximum of safety FU or 30 days after last dose (median 47 weeks follow-up) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Urinary tract infection	0.00% 0/19 • First dose through maximum of safety FU or 30 days after last dose (median 47 weeks follow-up) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.2% 1/24 • First dose through maximum of safety FU or 30 days after last dose (median 47 weeks follow-up) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Investigations Coagulation time prolonged	0.00% 0/19 • First dose through maximum of safety FU or 30 days after last dose (median 47 weeks follow-up) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.2% 1/24 • First dose through maximum of safety FU or 30 days after last dose (median 47 weeks follow-up) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Dehydration	10.5% 2/19 • First dose through maximum of safety FU or 30 days after last dose (median 47 weeks follow-up) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/24 • First dose through maximum of safety FU or 30 days after last dose (median 47 weeks follow-up) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Hypomagnesaemia	5.3% 1/19 • First dose through maximum of safety FU or 30 days after last dose (median 47 weeks follow-up) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/24 • First dose through maximum of safety FU or 30 days after last dose (median 47 weeks follow-up) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer metastatic	5.3% 1/19 • First dose through maximum of safety FU or 30 days after last dose (median 47 weeks follow-up) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/24 • First dose through maximum of safety FU or 30 days after last dose (median 47 weeks follow-up) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon neoplasm	5.3% 1/19 • First dose through maximum of safety FU or 30 days after last dose (median 47 weeks follow-up) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/24 • First dose through maximum of safety FU or 30 days after last dose (median 47 weeks follow-up) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal cancer metastatic	5.3% 1/19 • First dose through maximum of safety FU or 30 days after last dose (median 47 weeks follow-up) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/24 • First dose through maximum of safety FU or 30 days after last dose (median 47 weeks follow-up) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Renal and urinary disorders Haematuria	0.00% 0/19 • First dose through maximum of safety FU or 30 days after last dose (median 47 weeks follow-up) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.2% 1/24 • First dose through maximum of safety FU or 30 days after last dose (median 47 weeks follow-up) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Aspiration	5.3% 1/19 • First dose through maximum of safety FU or 30 days after last dose (median 47 weeks follow-up) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/24 • First dose through maximum of safety FU or 30 days after last dose (median 47 weeks follow-up) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/19 • First dose through maximum of safety FU or 30 days after last dose (median 47 weeks follow-up) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.2% 1/24 • First dose through maximum of safety FU or 30 days after last dose (median 47 weeks follow-up) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	5.3% 1/19 • First dose through maximum of safety FU or 30 days after last dose (median 47 weeks follow-up) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	8.3% 2/24 • First dose through maximum of safety FU or 30 days after last dose (median 47 weeks follow-up) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Deep vein thrombosis	0.00% 0/19 • First dose through maximum of safety FU or 30 days after last dose (median 47 weeks follow-up) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.2% 1/24 • First dose through maximum of safety FU or 30 days after last dose (median 47 weeks follow-up) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Haemorrhage	0.00% 0/19 • First dose through maximum of safety FU or 30 days after last dose (median 47 weeks follow-up) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.2% 1/24 • First dose through maximum of safety FU or 30 days after last dose (median 47 weeks follow-up) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.