Trial Outcomes & Findings for Dose Finding Study in Colorectal Cancer Patients Receiving 5-FU-based Chemotherapy to Assess the Efficacy of Elsiglutide in the Prevention of Chemotherapy Induced Diarrhea (CID) (NCT NCT02383810)

Last Updated: 2024-03-01

Results Overview

The endpoint of primary interest for efficacy was the proportion of patients within the Target population experiencing a maximum Grade ≥ 2 diarrhea in Cycle 1 (as assessed by the Investigator). For patient 8031362 who withdrew consent after 11 day in Cycle 1, Investigator assessments for the individual diarrhea events were missing. The data were imputed as Grade 0 for the primary endpoint, in line with the patient's eDiary data. Additional population is not included in primary endpoint evaluation.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

498 participants

Primary outcome timeframe

15 days

Results posted on

2024-03-01

Participant Flow

Participant milestones

Participant milestones
Measure	Elsiglutide 10 mg - Target Population Elsiglutide 10 mg once daily as s.c. injection for 4 consecutive days in patients receiving 5-FU based chemotherapy Elsiglutide	Elsiglutide 20 mg - Target Population Elsiglutide 20 mg once daily as s.c. injection for 4 consecutive days in patients receiving F-FU based chemotherapy Elsiglutide	Elsiglutide 40 mg - Target Population Elsiglutide 40 mg once daily as s.c. injection for 4 consecutive days in patients receiving 5-FU based chemotherapy Elsiglutide	Placebo - Target Population Placebo once daily as s.c. injection for 4 consecutive days in patients receiving 5-FU based chemotherapy Placebo	Elsiglutide 10 mg - Additional Population Elsiglutide 10 mg once daily as s.c. injection for 4 consecutive days in patients receiving 5-FU based chemotherapy with monoclonal antibody. Elsiglutide	Elsiglutide 20 mg - Additional Population Elsiglutide 20 mg once daily as s.c. injection for 4 consecutive days in patients receiving 5-FU based chemotherapy with monoclonal antibody. Elsiglutide	Elsiglutide 40 mg - Additional Population Elsiglutide 40 mg once daily as s.c. injection for 4 consecutive days in patients receiving 5-FU based chemotherapy with monoclonal antibody. Elsiglutide	Placebo - Additional Population Placebo once daily as s.c. injection for 4 consecutive days in patients receiving 5-FU based chemotherapy with monoclonal antibody. Placebo
Overall Study STARTED	120	122	120	123	4	4	3	2
Overall Study COMPLETED	117	114	113	112	4	3	2	2
Overall Study NOT COMPLETED	3	8	7	11	0	1	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Elsiglutide 10 mg - Target Population Elsiglutide 10 mg once daily as s.c. injection for 4 consecutive days in patients receiving 5-FU based chemotherapy Elsiglutide	Elsiglutide 20 mg - Target Population Elsiglutide 20 mg once daily as s.c. injection for 4 consecutive days in patients receiving F-FU based chemotherapy Elsiglutide	Elsiglutide 40 mg - Target Population Elsiglutide 40 mg once daily as s.c. injection for 4 consecutive days in patients receiving 5-FU based chemotherapy Elsiglutide	Placebo - Target Population Placebo once daily as s.c. injection for 4 consecutive days in patients receiving 5-FU based chemotherapy Placebo	Elsiglutide 20 mg - Additional Population Elsiglutide 20 mg once daily as s.c. injection for 4 consecutive days in patients receiving 5-FU based chemotherapy with monoclonal antibody. Elsiglutide	Elsiglutide 40 mg - Additional Population Elsiglutide 40 mg once daily as s.c. injection for 4 consecutive days in patients receiving 5-FU based chemotherapy with monoclonal antibody. Elsiglutide
Overall Study Physician Decision	1	1	0	0	0	0
Overall Study Withdrawal by Subject	2	3	3	3	0	0
Overall Study Adverse Event	0	2	4	5	1	1
Overall Study Lost to Follow-up	0	1	0	1	0	0
Overall Study other	0	0	0	2	0	0
Overall Study subject did not receive study treatment	0	1	0	0	0	0

Baseline Characteristics

Dose Finding Study in Colorectal Cancer Patients Receiving 5-FU-based Chemotherapy to Assess the Efficacy of Elsiglutide in the Prevention of Chemotherapy Induced Diarrhea (CID)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Elsiglutide 10 mg - Target Population n=120 Participants Elsiglutide 10 mg once daily as s.c. injection for 4 consecutive days in patients receiving 5-FU based chemotherapy Elsiglutide	Elsiglutide 20 mg - Target Population n=121 Participants Elsiglutide 20 mg once daily as s.c. injection for 4 consecutive days in patients receiving F-FU based chemotherapy Elsiglutide	Elsiglutide 40 mg - Target Population n=120 Participants Elsiglutide 40 mg once daily as s.c. injection for 4 consecutive days in patients receiving 5-FU based chemotherapy Elsiglutide	Placebo - Target Population n=123 Participants Placebo once daily as s.c. injection for 4 consecutive days in patients receiving 5-FU based chemotherapy Placebo	Elsiglutide 10 mg - Additional Population n=4 Participants Elsiglutide 10 mg once daily as s.c. injection for 4 consecutive days in patients receiving 5-FU based chemotherapy with monoclonal antibody. Elsiglutide	Elsiglutide 20 mg - Additional Population n=4 Participants Elsiglutide 20 mg once daily as s.c. injection for 4 consecutive days in patients receiving 5-FU based chemotherapy with monoclonal antibody. Elsiglutide	Elsiglutide 40 mg - Additional Population n=3 Participants Elsiglutide 40 mg once daily as s.c. injection for 4 consecutive days in patients receiving 5-FU based chemotherapy with monoclonal antibody. Elsiglutide	Placebo - Additional Population n=2 Participants Placebo once daily as s.c. injection for 4 consecutive days in patients receiving 5-FU based chemotherapy with monoclonal antibody. Placebo	Total n=497 Participants Total of all reporting groups
Age, Continuous	58.3 years STANDARD_DEVIATION 10.42 • n=5 Participants	59.0 years STANDARD_DEVIATION 10.84 • n=7 Participants	60.6 years STANDARD_DEVIATION 8.44 • n=5 Participants	61.9 years STANDARD_DEVIATION 9.57 • n=4 Participants	62.0 years STANDARD_DEVIATION 8.76 • n=21 Participants	55.8 years STANDARD_DEVIATION 12.53 • n=10 Participants	57.7 years STANDARD_DEVIATION 4.04 • n=115 Participants	57.0 years STANDARD_DEVIATION 7.07 • n=24 Participants	61 years STANDARD_DEVIATION 9.88 • n=42 Participants
Sex: Female, Male Female	54 Participants n=5 Participants	62 Participants n=7 Participants	51 Participants n=5 Participants	59 Participants n=4 Participants	3 Participants n=21 Participants	1 Participants n=10 Participants	2 Participants n=115 Participants	0 Participants n=24 Participants	232 Participants n=42 Participants
Sex: Female, Male Male	66 Participants n=5 Participants	59 Participants n=7 Participants	69 Participants n=5 Participants	64 Participants n=4 Participants	1 Participants n=21 Participants	3 Participants n=10 Participants	1 Participants n=115 Participants	2 Participants n=24 Participants	265 Participants n=42 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) White	118 Participants n=5 Participants	120 Participants n=7 Participants	117 Participants n=5 Participants	123 Participants n=4 Participants	4 Participants n=21 Participants	4 Participants n=10 Participants	3 Participants n=115 Participants	2 Participants n=24 Participants	491 Participants n=42 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	5 Participants n=42 Participants

PRIMARY outcome

Timeframe: 15 days

Population: FAS Target population, not including additional population

Outcome measures

Outcome measures
Measure	Elsiglutide 10 mg - Target Population n=120 Participants Elsiglutide 10 mg once daily as s.c. injection for 4 consecutive days in patients receiving 5-FU based chemotherapy Elsiglutide	Elsiglutide 20 mg - Target Population n=121 Participants Elsiglutide 20 mg once daily as s.c. injection for 4 consecutive days in patients receiving F-FU based chemotherapy Elsiglutide	Elsiglutide 40 mg - Target Population n=120 Participants Elsiglutide 40 mg once daily as s.c. injection for 4 consecutive days in patients receiving 5-FU based chemotherapy Elsiglutide	Placebo - Target Population n=123 Participants Placebo once daily as s.c. injection for 4 consecutive days in patients receiving 5-FU based chemotherapy Placebo
Proportion of Patients Experiencing a Maximum Grade ≥ 2 Diarrhea During the First Cycle of Chemotherapy in the Target Population With maximum Grade < 2 diarrhea	97.5 percentage of patients	95.0 percentage of patients	94.2 percentage of patients	90.2 percentage of patients
Proportion of Patients Experiencing a Maximum Grade ≥ 2 Diarrhea During the First Cycle of Chemotherapy in the Target Population With maximum Grade ≥ 2 diarrhea	2.5 percentage of patients	5.0 percentage of patients	5.8 percentage of patients	9.8 percentage of patients

Adverse Events

Elsiglutide 10 mg - Overall Set

Serious events: 2 serious events

Other events: 71 other events

Deaths: 1 deaths

Elsiglutide 20 mg - Overall

Serious events: 4 serious events

Other events: 68 other events

Deaths: 1 deaths

Elsiglutide 40 mg - Overall

Serious events: 3 serious events

Other events: 73 other events

Deaths: 2 deaths

Placebo - Overall

Serious events: 6 serious events

Other events: 72 other events

Deaths: 3 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Elsiglutide 10 mg - Overall Set n=124 participants at risk Adverse events occurring during Cycle 1 + 2 are reported. The safety (SAF) set was defined as all treated patients. "Patients treated" was defined as any patient who received any study medication (elsiglutide or placebo) on at least 1 day. The SAF Overall set was defined as all patients who were part of the SAF (either of SAF Target set or of SAF Additional set).	Elsiglutide 20 mg - Overall n=125 participants at risk Adverse events occurring during Cycle 1 + 2 are reported. The safety (SAF) set was defined as all treated patients. "Patients treated" was defined as any patient who received any study medication (elsiglutide or placebo) on at least 1 day. The SAF Overall set was defined as all patients who were part of the SAF (either of SAF Target set or of SAF Additional set).	Elsiglutide 40 mg - Overall n=123 participants at risk Adverse events occurring during Cycle 1 + 2 are reported. The safety (SAF) set was defined as all treated patients. "Patients treated" was defined as any patient who received any study medication (elsiglutide or placebo) on at least 1 day. The SAF Overall set was defined as all patients who were part of the SAF (either of SAF Target set or of SAF Additional set).	Placebo - Overall n=125 participants at risk Adverse events occurring during Cycle 1 + 2 are reported. The safety (SAF) set was defined as all treated patients. "Patients treated" was defined as any patient who received any study medication (elsiglutide or placebo) on at least 1 day. The SAF Overall set was defined as all patients who were part of the SAF (either of SAF Target set or of SAF Additional set).
Blood and lymphatic system disorders Anaemia	4.8% 6/124 • AEs were collected from signature of Informed Consent until End of Trial visit (Day 14 after start of last cycle). Duration of collection was 7-8 weeks for each patient. The safety (SAF) set was defined as all treated patients. "Patients treated" was defined as any patient who received any study medication (elsiglutide or placebo) on at least 1 day. SAF Overall set was defined as all patients who were part of the SAF (either of SAF Target set or of SAF Additional set). Adverse events are reported for Cycles 1+2.	5.6% 7/125 • AEs were collected from signature of Informed Consent until End of Trial visit (Day 14 after start of last cycle). Duration of collection was 7-8 weeks for each patient. The safety (SAF) set was defined as all treated patients. "Patients treated" was defined as any patient who received any study medication (elsiglutide or placebo) on at least 1 day. SAF Overall set was defined as all patients who were part of the SAF (either of SAF Target set or of SAF Additional set). Adverse events are reported for Cycles 1+2.	5.7% 7/123 • AEs were collected from signature of Informed Consent until End of Trial visit (Day 14 after start of last cycle). Duration of collection was 7-8 weeks for each patient. The safety (SAF) set was defined as all treated patients. "Patients treated" was defined as any patient who received any study medication (elsiglutide or placebo) on at least 1 day. SAF Overall set was defined as all patients who were part of the SAF (either of SAF Target set or of SAF Additional set). Adverse events are reported for Cycles 1+2.	7.2% 9/125 • AEs were collected from signature of Informed Consent until End of Trial visit (Day 14 after start of last cycle). Duration of collection was 7-8 weeks for each patient. The safety (SAF) set was defined as all treated patients. "Patients treated" was defined as any patient who received any study medication (elsiglutide or placebo) on at least 1 day. SAF Overall set was defined as all patients who were part of the SAF (either of SAF Target set or of SAF Additional set). Adverse events are reported for Cycles 1+2.
Blood and lymphatic system disorders Leukopenia	4.8% 6/124 • AEs were collected from signature of Informed Consent until End of Trial visit (Day 14 after start of last cycle). Duration of collection was 7-8 weeks for each patient. The safety (SAF) set was defined as all treated patients. "Patients treated" was defined as any patient who received any study medication (elsiglutide or placebo) on at least 1 day. SAF Overall set was defined as all patients who were part of the SAF (either of SAF Target set or of SAF Additional set). Adverse events are reported for Cycles 1+2.	8.0% 10/125 • AEs were collected from signature of Informed Consent until End of Trial visit (Day 14 after start of last cycle). Duration of collection was 7-8 weeks for each patient. The safety (SAF) set was defined as all treated patients. "Patients treated" was defined as any patient who received any study medication (elsiglutide or placebo) on at least 1 day. SAF Overall set was defined as all patients who were part of the SAF (either of SAF Target set or of SAF Additional set). Adverse events are reported for Cycles 1+2.	4.9% 6/123 • AEs were collected from signature of Informed Consent until End of Trial visit (Day 14 after start of last cycle). Duration of collection was 7-8 weeks for each patient. The safety (SAF) set was defined as all treated patients. "Patients treated" was defined as any patient who received any study medication (elsiglutide or placebo) on at least 1 day. SAF Overall set was defined as all patients who were part of the SAF (either of SAF Target set or of SAF Additional set). Adverse events are reported for Cycles 1+2.	9.6% 12/125 • AEs were collected from signature of Informed Consent until End of Trial visit (Day 14 after start of last cycle). Duration of collection was 7-8 weeks for each patient. The safety (SAF) set was defined as all treated patients. "Patients treated" was defined as any patient who received any study medication (elsiglutide or placebo) on at least 1 day. SAF Overall set was defined as all patients who were part of the SAF (either of SAF Target set or of SAF Additional set). Adverse events are reported for Cycles 1+2.
Blood and lymphatic system disorders Neutropenia	25.8% 32/124 • AEs were collected from signature of Informed Consent until End of Trial visit (Day 14 after start of last cycle). Duration of collection was 7-8 weeks for each patient. The safety (SAF) set was defined as all treated patients. "Patients treated" was defined as any patient who received any study medication (elsiglutide or placebo) on at least 1 day. SAF Overall set was defined as all patients who were part of the SAF (either of SAF Target set or of SAF Additional set). Adverse events are reported for Cycles 1+2.	23.2% 29/125 • AEs were collected from signature of Informed Consent until End of Trial visit (Day 14 after start of last cycle). Duration of collection was 7-8 weeks for each patient. The safety (SAF) set was defined as all treated patients. "Patients treated" was defined as any patient who received any study medication (elsiglutide or placebo) on at least 1 day. SAF Overall set was defined as all patients who were part of the SAF (either of SAF Target set or of SAF Additional set). Adverse events are reported for Cycles 1+2.	21.1% 26/123 • AEs were collected from signature of Informed Consent until End of Trial visit (Day 14 after start of last cycle). Duration of collection was 7-8 weeks for each patient. The safety (SAF) set was defined as all treated patients. "Patients treated" was defined as any patient who received any study medication (elsiglutide or placebo) on at least 1 day. SAF Overall set was defined as all patients who were part of the SAF (either of SAF Target set or of SAF Additional set). Adverse events are reported for Cycles 1+2.	25.6% 32/125 • AEs were collected from signature of Informed Consent until End of Trial visit (Day 14 after start of last cycle). Duration of collection was 7-8 weeks for each patient. The safety (SAF) set was defined as all treated patients. "Patients treated" was defined as any patient who received any study medication (elsiglutide or placebo) on at least 1 day. SAF Overall set was defined as all patients who were part of the SAF (either of SAF Target set or of SAF Additional set). Adverse events are reported for Cycles 1+2.
General disorders Asthenia	7.3% 9/124 • AEs were collected from signature of Informed Consent until End of Trial visit (Day 14 after start of last cycle). Duration of collection was 7-8 weeks for each patient. The safety (SAF) set was defined as all treated patients. "Patients treated" was defined as any patient who received any study medication (elsiglutide or placebo) on at least 1 day. SAF Overall set was defined as all patients who were part of the SAF (either of SAF Target set or of SAF Additional set). Adverse events are reported for Cycles 1+2.	6.4% 8/125 • AEs were collected from signature of Informed Consent until End of Trial visit (Day 14 after start of last cycle). Duration of collection was 7-8 weeks for each patient. The safety (SAF) set was defined as all treated patients. "Patients treated" was defined as any patient who received any study medication (elsiglutide or placebo) on at least 1 day. SAF Overall set was defined as all patients who were part of the SAF (either of SAF Target set or of SAF Additional set). Adverse events are reported for Cycles 1+2.	5.7% 7/123 • AEs were collected from signature of Informed Consent until End of Trial visit (Day 14 after start of last cycle). Duration of collection was 7-8 weeks for each patient. The safety (SAF) set was defined as all treated patients. "Patients treated" was defined as any patient who received any study medication (elsiglutide or placebo) on at least 1 day. SAF Overall set was defined as all patients who were part of the SAF (either of SAF Target set or of SAF Additional set). Adverse events are reported for Cycles 1+2.	5.6% 7/125 • AEs were collected from signature of Informed Consent until End of Trial visit (Day 14 after start of last cycle). Duration of collection was 7-8 weeks for each patient. The safety (SAF) set was defined as all treated patients. "Patients treated" was defined as any patient who received any study medication (elsiglutide or placebo) on at least 1 day. SAF Overall set was defined as all patients who were part of the SAF (either of SAF Target set or of SAF Additional set). Adverse events are reported for Cycles 1+2.
General disorders Injection site erythema	0.81% 1/124 • AEs were collected from signature of Informed Consent until End of Trial visit (Day 14 after start of last cycle). Duration of collection was 7-8 weeks for each patient. The safety (SAF) set was defined as all treated patients. "Patients treated" was defined as any patient who received any study medication (elsiglutide or placebo) on at least 1 day. SAF Overall set was defined as all patients who were part of the SAF (either of SAF Target set or of SAF Additional set). Adverse events are reported for Cycles 1+2.	2.4% 3/125 • AEs were collected from signature of Informed Consent until End of Trial visit (Day 14 after start of last cycle). Duration of collection was 7-8 weeks for each patient. The safety (SAF) set was defined as all treated patients. "Patients treated" was defined as any patient who received any study medication (elsiglutide or placebo) on at least 1 day. SAF Overall set was defined as all patients who were part of the SAF (either of SAF Target set or of SAF Additional set). Adverse events are reported for Cycles 1+2.	8.1% 10/123 • AEs were collected from signature of Informed Consent until End of Trial visit (Day 14 after start of last cycle). Duration of collection was 7-8 weeks for each patient. The safety (SAF) set was defined as all treated patients. "Patients treated" was defined as any patient who received any study medication (elsiglutide or placebo) on at least 1 day. SAF Overall set was defined as all patients who were part of the SAF (either of SAF Target set or of SAF Additional set). Adverse events are reported for Cycles 1+2.	0.00% 0/125 • AEs were collected from signature of Informed Consent until End of Trial visit (Day 14 after start of last cycle). Duration of collection was 7-8 weeks for each patient. The safety (SAF) set was defined as all treated patients. "Patients treated" was defined as any patient who received any study medication (elsiglutide or placebo) on at least 1 day. SAF Overall set was defined as all patients who were part of the SAF (either of SAF Target set or of SAF Additional set). Adverse events are reported for Cycles 1+2.
Gastrointestinal disorders Abdominal tenderness	0.00% 0/124 • AEs were collected from signature of Informed Consent until End of Trial visit (Day 14 after start of last cycle). Duration of collection was 7-8 weeks for each patient. The safety (SAF) set was defined as all treated patients. "Patients treated" was defined as any patient who received any study medication (elsiglutide or placebo) on at least 1 day. SAF Overall set was defined as all patients who were part of the SAF (either of SAF Target set or of SAF Additional set). Adverse events are reported for Cycles 1+2.	8.8% 11/125 • AEs were collected from signature of Informed Consent until End of Trial visit (Day 14 after start of last cycle). Duration of collection was 7-8 weeks for each patient. The safety (SAF) set was defined as all treated patients. "Patients treated" was defined as any patient who received any study medication (elsiglutide or placebo) on at least 1 day. SAF Overall set was defined as all patients who were part of the SAF (either of SAF Target set or of SAF Additional set). Adverse events are reported for Cycles 1+2.	5.7% 7/123 • AEs were collected from signature of Informed Consent until End of Trial visit (Day 14 after start of last cycle). Duration of collection was 7-8 weeks for each patient. The safety (SAF) set was defined as all treated patients. "Patients treated" was defined as any patient who received any study medication (elsiglutide or placebo) on at least 1 day. SAF Overall set was defined as all patients who were part of the SAF (either of SAF Target set or of SAF Additional set). Adverse events are reported for Cycles 1+2.	5.6% 7/125 • AEs were collected from signature of Informed Consent until End of Trial visit (Day 14 after start of last cycle). Duration of collection was 7-8 weeks for each patient. The safety (SAF) set was defined as all treated patients. "Patients treated" was defined as any patient who received any study medication (elsiglutide or placebo) on at least 1 day. SAF Overall set was defined as all patients who were part of the SAF (either of SAF Target set or of SAF Additional set). Adverse events are reported for Cycles 1+2.
Gastrointestinal disorders Nausea	16.9% 21/124 • AEs were collected from signature of Informed Consent until End of Trial visit (Day 14 after start of last cycle). Duration of collection was 7-8 weeks for each patient. The safety (SAF) set was defined as all treated patients. "Patients treated" was defined as any patient who received any study medication (elsiglutide or placebo) on at least 1 day. SAF Overall set was defined as all patients who were part of the SAF (either of SAF Target set or of SAF Additional set). Adverse events are reported for Cycles 1+2.	13.6% 17/125 • AEs were collected from signature of Informed Consent until End of Trial visit (Day 14 after start of last cycle). Duration of collection was 7-8 weeks for each patient. The safety (SAF) set was defined as all treated patients. "Patients treated" was defined as any patient who received any study medication (elsiglutide or placebo) on at least 1 day. SAF Overall set was defined as all patients who were part of the SAF (either of SAF Target set or of SAF Additional set). Adverse events are reported for Cycles 1+2.	12.2% 15/123 • AEs were collected from signature of Informed Consent until End of Trial visit (Day 14 after start of last cycle). Duration of collection was 7-8 weeks for each patient. The safety (SAF) set was defined as all treated patients. "Patients treated" was defined as any patient who received any study medication (elsiglutide or placebo) on at least 1 day. SAF Overall set was defined as all patients who were part of the SAF (either of SAF Target set or of SAF Additional set). Adverse events are reported for Cycles 1+2.	13.6% 17/125 • AEs were collected from signature of Informed Consent until End of Trial visit (Day 14 after start of last cycle). Duration of collection was 7-8 weeks for each patient. The safety (SAF) set was defined as all treated patients. "Patients treated" was defined as any patient who received any study medication (elsiglutide or placebo) on at least 1 day. SAF Overall set was defined as all patients who were part of the SAF (either of SAF Target set or of SAF Additional set). Adverse events are reported for Cycles 1+2.
Gastrointestinal disorders Vomiting	0.81% 1/124 • AEs were collected from signature of Informed Consent until End of Trial visit (Day 14 after start of last cycle). Duration of collection was 7-8 weeks for each patient. The safety (SAF) set was defined as all treated patients. "Patients treated" was defined as any patient who received any study medication (elsiglutide or placebo) on at least 1 day. SAF Overall set was defined as all patients who were part of the SAF (either of SAF Target set or of SAF Additional set). Adverse events are reported for Cycles 1+2.	2.4% 3/125 • AEs were collected from signature of Informed Consent until End of Trial visit (Day 14 after start of last cycle). Duration of collection was 7-8 weeks for each patient. The safety (SAF) set was defined as all treated patients. "Patients treated" was defined as any patient who received any study medication (elsiglutide or placebo) on at least 1 day. SAF Overall set was defined as all patients who were part of the SAF (either of SAF Target set or of SAF Additional set). Adverse events are reported for Cycles 1+2.	5.7% 7/123 • AEs were collected from signature of Informed Consent until End of Trial visit (Day 14 after start of last cycle). Duration of collection was 7-8 weeks for each patient. The safety (SAF) set was defined as all treated patients. "Patients treated" was defined as any patient who received any study medication (elsiglutide or placebo) on at least 1 day. SAF Overall set was defined as all patients who were part of the SAF (either of SAF Target set or of SAF Additional set). Adverse events are reported for Cycles 1+2.	4.0% 5/125 • AEs were collected from signature of Informed Consent until End of Trial visit (Day 14 after start of last cycle). Duration of collection was 7-8 weeks for each patient. The safety (SAF) set was defined as all treated patients. "Patients treated" was defined as any patient who received any study medication (elsiglutide or placebo) on at least 1 day. SAF Overall set was defined as all patients who were part of the SAF (either of SAF Target set or of SAF Additional set). Adverse events are reported for Cycles 1+2.

Additional Information

Director of Clinical Division

Helsinn Healthcare SA

Phone: +41 91 9852121

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place