Trial Outcomes & Findings for A Study of IMC-1121B (Ramucirumab) in Colorectal Cancer (NCT NCT00862784)
NCT ID: NCT00862784
Last Updated: 2014-06-17
Results Overview
PFS was defined as the time from date of first dose to the first observation of progression of disease (PD) or death due to any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. PD is ≥20% increase in sum of longest diameter of target lesions and/or unequivocal progression of non-target lesion and/or new lesion. For participants who had no PD or death or had started new therapeutic anticancer treatment, PFS was censored at their last radiographic tumor assessment.
COMPLETED
PHASE2
48 participants
First dose to measured progressive disease or death due to any cause up to 28.1 months
2014-06-17
Participant Flow
Completer was defined as any participant who died due to any cause or progression of disease, or any participant who was alive and on study but off study treatment at the conclusion of the study.
Participant milestones
| Measure |
IMC-1121B (Ramucirumab) + mFOLFOX-6
Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 \[folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6\] regimen as follows:
Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.
This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal.
|
|---|---|
|
Overall Study
STARTED
|
48
|
|
Overall Study
Received Any Amount of Study Drug
|
48
|
|
Overall Study
COMPLETED
|
48
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of IMC-1121B (Ramucirumab) in Colorectal Cancer
Baseline characteristics by cohort
| Measure |
IMC-1121B (Ramucirumab) + mFOLFOX-6
n=48 Participants
Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 \[folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6\] regimen as follows:
Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.
This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
31 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
43 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
48 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
5 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
43 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: First dose to measured progressive disease or death due to any cause up to 28.1 monthsPopulation: All participants who received any amount of study drug. The number of participants censored was 11.
PFS was defined as the time from date of first dose to the first observation of progression of disease (PD) or death due to any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. PD is ≥20% increase in sum of longest diameter of target lesions and/or unequivocal progression of non-target lesion and/or new lesion. For participants who had no PD or death or had started new therapeutic anticancer treatment, PFS was censored at their last radiographic tumor assessment.
Outcome measures
| Measure |
IMC-1121B (Ramucirumab) + mFOLFOX-6
n=48 Participants
Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 \[folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6\] regimen as follows:
Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.
This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal.
|
|---|---|
|
Progression-Free Survival (PFS)
|
11.5 months
Interval 8.6 to 13.1
|
SECONDARY outcome
Timeframe: First dose to date of objective progressive disease up to 23.8 monthsPopulation: All participants who received any amount of study drug.
ORR is the percentage of participants with a confirmed complete response (CR) + partial response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. CR is disappearance of all target and non-target lesions; PR is a ≥30% decrease in sum of longest diameter of target lesions without new lesion and progression of non-target lesion. ORR is calculated as a total number of participants with CR or PR from the start of study treatment until disease progression or recurrence divided by the total number of participants treated, then multiplied by 100.
Outcome measures
| Measure |
IMC-1121B (Ramucirumab) + mFOLFOX-6
n=48 Participants
Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 \[folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6\] regimen as follows:
Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.
This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal.
|
|---|---|
|
Percentage of Participants With Complete Response or Partial Response [Objective Response Rate (ORR)]
|
58.3 percentage of participants
Interval 43.21 to 72.39
|
SECONDARY outcome
Timeframe: First dose to death due to any cause up to 28.1 monthsPopulation: All participants who received any amount of study drug. The number of participants censored was 18.
OS was defined as the time from first dose to the date of death due to any cause. For participants who were alive or were lost to follow-up, OS was censored on the last date the participant was known to be alive.
Outcome measures
| Measure |
IMC-1121B (Ramucirumab) + mFOLFOX-6
n=48 Participants
Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 \[folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6\] regimen as follows:
Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.
This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal.
|
|---|---|
|
Overall Survival (OS)
|
20.4 months
Interval 18.5 to 25.1
|
SECONDARY outcome
Timeframe: Time of response to time of measured progressive disease up to 22.2 monthsPopulation: All participants who received any amount of study drug who had CR and PR.
The duration of response was defined as the time from first objective status assessment of complete response (CR) or partial response (PR) to the first time of progression or death as a result of any cause. CR or PR is classified by the investigators according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. CR is disappearance of all target and non-target lesions; PR is a ≥30% decrease in sum of longest diameter of target lesions without new lesion and progression of non-target lesion.
Outcome measures
| Measure |
IMC-1121B (Ramucirumab) + mFOLFOX-6
n=28 Participants
Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 \[folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6\] regimen as follows:
Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.
This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal.
|
|---|---|
|
Duration of Response
|
11.0 months
Interval 6.9 to 12.6
|
SECONDARY outcome
Timeframe: First dose to 25.2 monthsPopulation: All participants who received at any amount of study drug.
Data presented are the number of participants who experienced AEs of any grade and AEs of Grade ≥3 based on National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3.0 (NCI-CTCAE v 3.0), that were considered to be related to IMC-1121B (ramucirumab) by the investigators. A summary of serious AEs (SAEs) and all other non-serious AEs regardless of causality, is located in the Reported Adverse Events module.
Outcome measures
| Measure |
IMC-1121B (Ramucirumab) + mFOLFOX-6
n=48 Participants
Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 \[folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6\] regimen as follows:
Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.
This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal.
|
|---|---|
|
Number of Participants With IMC-1121B (Ramucirumab)-Related Adverse Events (AEs)
Related AEs
|
45 participants
|
|
Number of Participants With IMC-1121B (Ramucirumab)-Related Adverse Events (AEs)
Related AEs of Grade ≥3
|
19 participants
|
|
Number of Participants With IMC-1121B (Ramucirumab)-Related Adverse Events (AEs)
Related AE resulting in death
|
2 participants
|
|
Number of Participants With IMC-1121B (Ramucirumab)-Related Adverse Events (AEs)
Related AE leading to discontinuation
|
11 participants
|
SECONDARY outcome
Timeframe: First dose to 25.2 monthsPopulation: All participants who received any amount of study drug.
Data presented are the number of participants who experienced SAEs, adverse events (AEs) resulting in death and AEs leading to discontinuation of treatment, that were considered to be related to IMC-1121B (ramucirumab) by the investigators. A summary of SAEs and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.
Outcome measures
| Measure |
IMC-1121B (Ramucirumab) + mFOLFOX-6
n=48 Participants
Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 \[folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6\] regimen as follows:
Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.
This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal.
|
|---|---|
|
Number of Participants With IMC-1121B (Ramucirumab)-Related Severe Adverse Events (SAEs)
|
10 participants
|
SECONDARY outcome
Timeframe: Baseline, 1, 168, and 336 hours post infusion on Day 1 (Cycle 1)Population: No participants were analyzed due to sparse pharmacokinetic schedule.
Due to sparse pharmacokinetic schedule, Cmax was not calculated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 1, 168, and 336 hours post infusion on Day 1 (Cycle 1)Population: No participants were analyzed due to sparse pharmacokinetic schedule.
Due to sparse pharmacokinetic schedule, AUC was not calculated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 1, 168, and 336 hours post infusion on Day 1 (Cycle 1)Population: No participants were analyzed due to sparse pharmacokinetic schedule.
Due to sparse pharmacokinetic schedule, t1/2 was not calculated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 1, 168, and 336 hours post infusion on Day 1 (Cycle 1)Population: No participants were analyzed due to sparse pharmacokinetic schedule.
Due to sparse pharmacokinetic schedule, CL was not calculated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 1, 168, and 336 hours post infusion Day 1 (Cycle 1)Population: No participants were analyzed due to sparse pharmacokinetic schedule.
Due to sparse pharmacokinetic schedule, Vss was not calculated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 1 hour post infusion on Day 1 (Cycles 5, 9, 13, 17, and 21)Population: No participants were analyzed due to sparse pharmacokinetic schedule.
Due to sparse pharmacokinetic schedule, Cmax was not calculated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 1 hour post infusion on Day 1 (Cycles 5, 9, 13, 17, and 21)Population: No participants were analyzed due to sparse pharmacokinetic schedule.
Due to sparse pharmacokinetic schedule, AUC was not calculated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 1 hour post infusion on Day 1 (Cycles 5, 9, 13, 17, and 21)Population: No participants were analyzed due to sparse pharmacokinetic schedule.
Due to sparse pharmacokinetic schedule, t1/2 was not calculated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 1 hour post infusion on Day 1 (Cycles 5, 9, 13, 17, and 21)Population: No participants were analyzed due to sparse pharmacokinetic schedule.
Due to sparse pharmacokinetic schedule, CL was not calculated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 1 hour post infusion on Day 1 (Cycles 5, 9, 13, 17, and 21)Population: No participants were analyzed due to sparse pharmacokinetic schedule.
Due to sparse pharmacokinetic schedule, Vss was not calculated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 (Cycles 1, 5, 9, and 30-day follow-up)Population: All participants who received any amount of study drug and had serum Anti-IMC-1121B (ramucirumab) evaluated.
Data presented are the number of participants with treatment emergent anti-IMC-112B antibodies.
Outcome measures
| Measure |
IMC-1121B (Ramucirumab) + mFOLFOX-6
n=48 Participants
Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 \[folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6\] regimen as follows:
Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.
This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal.
|
|---|---|
|
Serum Anti-IMC-1121B (Immunogenicity) at Day 1
Cycle 1 (n=39)
|
0 participants
|
|
Serum Anti-IMC-1121B (Immunogenicity) at Day 1
Cycle 5 (n=33)
|
2 participants
|
|
Serum Anti-IMC-1121B (Immunogenicity) at Day 1
Cycle 9 (n=25)
|
0 participants
|
|
Serum Anti-IMC-1121B (Immunogenicity) at Day 1
30-day Follow-up (n=17)
|
2 participants
|
Adverse Events
IMC-1121B (Ramucirumab) + mFOLFOX-6
Serious adverse events
| Measure |
IMC-1121B (Ramucirumab) + mFOLFOX-6
n=48 participants at risk
Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 \[folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6\] regimen as follows:
Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.
This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal.
|
|---|---|
|
Blood and lymphatic system disorders
COAGULOPATHY
|
2.1%
1/48 • Number of events 1
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
2.1%
1/48 • Number of events 1
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
2.1%
1/48 • Number of events 3
|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
2.1%
1/48 • Number of events 1
|
|
Cardiac disorders
CARDIO-RESPIRATORY ARREST
|
2.1%
1/48 • Number of events 1
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
2.1%
1/48 • Number of events 1
|
|
Gastrointestinal disorders
DIARRHOEA
|
2.1%
1/48 • Number of events 1
|
|
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
|
2.1%
1/48 • Number of events 1
|
|
General disorders
DISEASE PROGRESSION
|
4.2%
2/48 • Number of events 2
|
|
General disorders
PYREXIA
|
4.2%
2/48 • Number of events 2
|
|
Infections and infestations
ABDOMINAL ABSCESS
|
2.1%
1/48 • Number of events 1
|
|
Infections and infestations
ANAL ABSCESS
|
2.1%
1/48 • Number of events 1
|
|
Infections and infestations
HAEMOPHILUS INFECTION
|
2.1%
1/48 • Number of events 1
|
|
Infections and infestations
PELVIC ABSCESS
|
2.1%
1/48 • Number of events 1
|
|
Infections and infestations
PNEUMONIA
|
2.1%
1/48 • Number of events 1
|
|
Infections and infestations
UROSEPSIS
|
2.1%
1/48 • Number of events 1
|
|
Injury, poisoning and procedural complications
HIP FRACTURE
|
2.1%
1/48 • Number of events 1
|
|
Renal and urinary disorders
NEPHROTIC SYNDROME
|
2.1%
1/48 • Number of events 1
|
|
Reproductive system and breast disorders
OVARIAN TORSION
|
4.3%
1/23 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
2.1%
1/48 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
4.2%
2/48 • Number of events 2
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
2.1%
1/48 • Number of events 1
|
|
Vascular disorders
JUGULAR VEIN THROMBOSIS
|
2.1%
1/48 • Number of events 1
|
Other adverse events
| Measure |
IMC-1121B (Ramucirumab) + mFOLFOX-6
n=48 participants at risk
Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 \[folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6\] regimen as follows:
Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.
This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal.
|
|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
16.7%
8/48 • Number of events 12
|
|
Blood and lymphatic system disorders
HAEMOGLOBINAEMIA
|
6.2%
3/48 • Number of events 3
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
16.7%
8/48 • Number of events 22
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
56.2%
27/48 • Number of events 101
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
35.4%
17/48 • Number of events 41
|
|
Eye disorders
CONJUNCTIVITIS
|
8.3%
4/48 • Number of events 4
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
27.1%
13/48 • Number of events 14
|
|
Gastrointestinal disorders
CONSTIPATION
|
20.8%
10/48 • Number of events 13
|
|
Gastrointestinal disorders
DIARRHOEA
|
66.7%
32/48 • Number of events 150
|
|
Gastrointestinal disorders
DYSPEPSIA
|
10.4%
5/48 • Number of events 7
|
|
Gastrointestinal disorders
FLATULENCE
|
6.2%
3/48 • Number of events 3
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
6.2%
3/48 • Number of events 3
|
|
Gastrointestinal disorders
NAUSEA
|
43.8%
21/48 • Number of events 52
|
|
Gastrointestinal disorders
PROCTALGIA
|
6.2%
3/48 • Number of events 6
|
|
Gastrointestinal disorders
RECTAL HAEMORRHAGE
|
8.3%
4/48 • Number of events 9
|
|
Gastrointestinal disorders
STOMATITIS
|
16.7%
8/48 • Number of events 16
|
|
Gastrointestinal disorders
VOMITING
|
25.0%
12/48 • Number of events 28
|
|
General disorders
ASTHENIA
|
72.9%
35/48 • Number of events 154
|
|
General disorders
FATIGUE
|
8.3%
4/48 • Number of events 10
|
|
General disorders
INFUSION RELATED REACTION
|
18.8%
9/48 • Number of events 18
|
|
General disorders
MUCOSAL INFLAMMATION
|
54.2%
26/48 • Number of events 61
|
|
General disorders
OEDEMA PERIPHERAL
|
22.9%
11/48 • Number of events 19
|
|
General disorders
PYREXIA
|
27.1%
13/48 • Number of events 22
|
|
Infections and infestations
NASOPHARYNGITIS
|
10.4%
5/48 • Number of events 8
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
16.7%
8/48 • Number of events 11
|
|
Infections and infestations
URINARY TRACT INFECTION
|
10.4%
5/48 • Number of events 10
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
6.2%
3/48 • Number of events 6
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
8.3%
4/48 • Number of events 6
|
|
Investigations
GAMMA-GLUTAMYLTRANSFERASE INCREASED
|
10.4%
5/48 • Number of events 9
|
|
Investigations
WEIGHT DECREASED
|
6.2%
3/48 • Number of events 3
|
|
Metabolism and nutrition disorders
ANOREXIA
|
22.9%
11/48 • Number of events 15
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
10.4%
5/48 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
14.6%
7/48 • Number of events 11
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
8.3%
4/48 • Number of events 5
|
|
Nervous system disorders
DIZZINESS
|
6.2%
3/48 • Number of events 3
|
|
Nervous system disorders
DYSAESTHESIA
|
47.9%
23/48 • Number of events 97
|
|
Nervous system disorders
DYSGEUSIA
|
14.6%
7/48 • Number of events 10
|
|
Nervous system disorders
HEADACHE
|
14.6%
7/48 • Number of events 11
|
|
Nervous system disorders
HYPOAESTHESIA
|
6.2%
3/48 • Number of events 10
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
10.4%
5/48 • Number of events 11
|
|
Nervous system disorders
NEUROTOXICITY
|
66.7%
32/48 • Number of events 71
|
|
Nervous system disorders
PARAESTHESIA
|
14.6%
7/48 • Number of events 12
|
|
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
|
10.4%
5/48 • Number of events 9
|
|
Psychiatric disorders
INSOMNIA
|
8.3%
4/48 • Number of events 4
|
|
Renal and urinary disorders
DYSURIA
|
6.2%
3/48 • Number of events 4
|
|
Renal and urinary disorders
HAEMATURIA
|
6.2%
3/48 • Number of events 3
|
|
Renal and urinary disorders
PROTEINURIA
|
12.5%
6/48 • Number of events 10
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
10.4%
5/48 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
DYSAESTHESIA PHARYNX
|
12.5%
6/48 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
DYSPHONIA
|
8.3%
4/48 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
12.5%
6/48 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
31.2%
15/48 • Number of events 20
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
6.2%
3/48 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
18.8%
9/48 • Number of events 10
|
|
Skin and subcutaneous tissue disorders
DERMATITIS ACNEIFORM
|
8.3%
4/48 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
8.3%
4/48 • Number of events 7
|
|
Skin and subcutaneous tissue disorders
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME
|
22.9%
11/48 • Number of events 22
|
|
Vascular disorders
HYPERTENSION
|
56.2%
27/48 • Number of events 42
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Results disclosure agreements
- Principal investigator is a sponsor employee Investigators agreed to delay independently publishing or disclosing data, findings or conclusions from the study except as part of a multi-center publication. Upon study publication or if the draft publication is not produced within approximately 6 months of the final report of the study results, investigators may independently publish, subject to confidential information review/redaction by sponsor. The sponsor may request publication delay up to 90 days to seek patent protection.
- Publication restrictions are in place
Restriction type: OTHER