Trial Outcomes & Findings for Study of IMC-1121B (Ramucirumab) With Best Supportive Care in Participants With Gastric Cancer and Adenocarcinoma (NCT NCT00917384)
NCT ID: NCT00917384
Last Updated: 2019-09-25
Results Overview
Overall survival is defined as the time from the date of randomization to the date of death from any cause. Participants who were alive at the date of data cut-off or who were lost to follow-up were censored on the last date the participant was known to be alive
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
355 participants
Primary outcome timeframe
Randomization up to 28 months post-randomization
Results posted on
2019-09-25
Participant Flow
In the Participant Flow participants who completed were those who died due to any cause or were alive and on study at conclusion but off treatment.
Participant milestones
| Measure |
IMC-1121B (Ramucirumab )
Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined appropriate by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
|
Placebo
Participants received placebo by intravenous infusion every 2 weeks plus BSC as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
|
|---|---|---|
|
Overall Study
STARTED
|
238
|
117
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
236
|
115
|
|
Overall Study
COMPLETED
|
224
|
113
|
|
Overall Study
NOT COMPLETED
|
14
|
4
|
Reasons for withdrawal
| Measure |
IMC-1121B (Ramucirumab )
Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined appropriate by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
|
Placebo
Participants received placebo by intravenous infusion every 2 weeks plus BSC as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
2
|
|
Overall Study
Withdrawal by Subject
|
10
|
2
|
Baseline Characteristics
Study of IMC-1121B (Ramucirumab) With Best Supportive Care in Participants With Gastric Cancer and Adenocarcinoma
Baseline characteristics by cohort
| Measure |
IMC-1121B (Ramucirumab)
n=238 Participants
Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
|
Placebo
n=117 Participants
Participants received placebo by intravenous infusion every 2 weeks plus best supportive care as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
|
Total
n=355 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.0 years
n=99 Participants
|
60.0 years
n=107 Participants
|
60.0 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
69 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
107 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
169 Participants
n=99 Participants
|
79 Participants
n=107 Participants
|
248 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
41 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
197 Participants
n=99 Participants
|
98 Participants
n=107 Participants
|
295 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
Argentina
|
4 participants
n=99 Participants
|
2 participants
n=107 Participants
|
6 participants
n=206 Participants
|
|
Region of Enrollment
Australia
|
8 participants
n=99 Participants
|
4 participants
n=107 Participants
|
12 participants
n=206 Participants
|
|
Region of Enrollment
Bosnia and Herzegovina
|
1 participants
n=99 Participants
|
3 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Region of Enrollment
Brazil
|
24 participants
n=99 Participants
|
14 participants
n=107 Participants
|
38 participants
n=206 Participants
|
|
Region of Enrollment
Canada
|
8 participants
n=99 Participants
|
2 participants
n=107 Participants
|
10 participants
n=206 Participants
|
|
Region of Enrollment
Chile
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Region of Enrollment
Colombia
|
2 participants
n=99 Participants
|
1 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Region of Enrollment
Czech Republic
|
24 participants
n=99 Participants
|
13 participants
n=107 Participants
|
37 participants
n=206 Participants
|
|
Region of Enrollment
Egypt
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Region of Enrollment
Spain
|
12 participants
n=99 Participants
|
4 participants
n=107 Participants
|
16 participants
n=206 Participants
|
|
Region of Enrollment
United Kingdom
|
13 participants
n=99 Participants
|
4 participants
n=107 Participants
|
17 participants
n=206 Participants
|
|
Region of Enrollment
Guatemala
|
6 participants
n=99 Participants
|
2 participants
n=107 Participants
|
8 participants
n=206 Participants
|
|
Region of Enrollment
Croatia
|
7 participants
n=99 Participants
|
0 participants
n=107 Participants
|
7 participants
n=206 Participants
|
|
Region of Enrollment
Indonesia
|
2 participants
n=99 Participants
|
1 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Region of Enrollment
India
|
16 participants
n=99 Participants
|
8 participants
n=107 Participants
|
24 participants
n=206 Participants
|
|
Region of Enrollment
Italy
|
23 participants
n=99 Participants
|
11 participants
n=107 Participants
|
34 participants
n=206 Participants
|
|
Region of Enrollment
Korea, Republic of
|
11 participants
n=99 Participants
|
6 participants
n=107 Participants
|
17 participants
n=206 Participants
|
|
Region of Enrollment
Lebanon
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Region of Enrollment
Malta
|
2 participants
n=99 Participants
|
3 participants
n=107 Participants
|
5 participants
n=206 Participants
|
|
Region of Enrollment
New Zealand
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Region of Enrollment
Philippines
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Region of Enrollment
Poland
|
9 participants
n=99 Participants
|
4 participants
n=107 Participants
|
13 participants
n=206 Participants
|
|
Region of Enrollment
Romania
|
13 participants
n=99 Participants
|
4 participants
n=107 Participants
|
17 participants
n=206 Participants
|
|
Region of Enrollment
Russian Federation
|
14 participants
n=99 Participants
|
8 participants
n=107 Participants
|
22 participants
n=206 Participants
|
|
Region of Enrollment
Thailand
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Region of Enrollment
Turkey
|
5 participants
n=99 Participants
|
1 participants
n=107 Participants
|
6 participants
n=206 Participants
|
|
Region of Enrollment
Taiwan
|
3 participants
n=99 Participants
|
0 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=99 Participants
|
18 participants
n=107 Participants
|
43 participants
n=206 Participants
|
|
Region of Enrollment
South Africa
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Race
White
|
181 participants
n=99 Participants
|
91 participants
n=107 Participants
|
272 participants
n=206 Participants
|
|
Race
Asian
|
39 participants
n=99 Participants
|
17 participants
n=107 Participants
|
56 participants
n=206 Participants
|
|
Race
Black
|
4 participants
n=99 Participants
|
2 participants
n=107 Participants
|
6 participants
n=206 Participants
|
|
Race
Other
|
14 participants
n=99 Participants
|
7 participants
n=107 Participants
|
21 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Randomization up to 28 months post-randomizationPopulation: Intent-to-treat population: all randomized participants. Censored participants: ramucirumab=59, placebo=18.
Overall survival is defined as the time from the date of randomization to the date of death from any cause. Participants who were alive at the date of data cut-off or who were lost to follow-up were censored on the last date the participant was known to be alive
Outcome measures
| Measure |
IMC-1121B (Ramucirumab)
n=238 Participants
Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
|
Placebo
n=117 Participants
Participants received placebo by intravenous infusion every 2 weeks plus best supportive care as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
|
|---|---|---|
|
Overall Survival (OS)
|
5.2 months
Interval 4.4 to 5.7
|
3.8 months
Interval 2.8 to 4.7
|
SECONDARY outcome
Timeframe: Randomization up to 17 monthsPopulation: Intent-to-treat population: all randomized participants. Censored participants: ramucirumab=39, placebo=9.
PFS is defined as the time from date of randomization until date of objectively determined progressive disease (PD) or death due to any cause, whichever is first. Participants alive and without PD were censored at the time of last adequate objective tumor assessment (that is, response other than unevaluable).
Outcome measures
| Measure |
IMC-1121B (Ramucirumab)
n=238 Participants
Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
|
Placebo
n=117 Participants
Participants received placebo by intravenous infusion every 2 weeks plus best supportive care as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
|
|---|---|---|
|
Progression-Free Survival (PFS)
|
2.1 months
Interval 1.5 to 2.7
|
1.3 months
Interval 1.3 to 1.4
|
SECONDARY outcome
Timeframe: Week 12 post-randomizationPopulation: Intent-to-treat population: all randomized participants.
The percentage of participants alive and progression-free 12 weeks after randomization. Progression-free survival (PFS) is defined as the time from the date of randomization until the date of objectively determined progressive disease (PD) or death due to any cause whichever comes first. Participants alive and without PD were censored at the time of the last adequate objective tumor assessment.
Outcome measures
| Measure |
IMC-1121B (Ramucirumab)
n=238 Participants
Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
|
Placebo
n=117 Participants
Participants received placebo by intravenous infusion every 2 weeks plus best supportive care as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
|
|---|---|---|
|
Percentage of Participants Who Are Progression-Free at Week 12 (PFS Rate)
|
40.1 percentage of participants
Interval 33.6 to 46.4
|
15.8 percentage of participants
Interval 9.7 to 23.3
|
SECONDARY outcome
Timeframe: Randomization up to 17 months post-randomizationPopulation: Intent-to-treat population: all randomized participants.
ORR is equal to the percentage of participants achieving a best overall response of complete response (CR) or partial response (PR). CR and PR were defined using the Response Evaluation Criteria in Solid Tumors (RECIST v1.0). CR is defined as the disappearance of all target and non-target lesions, no appearance of new lesions and confirmed at the consecutive tumor assessment. PR is defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, no appearance of new lesions and confirmed at a subsequent tumor assessment.
Outcome measures
| Measure |
IMC-1121B (Ramucirumab)
n=238 Participants
Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
|
Placebo
n=117 Participants
Participants received placebo by intravenous infusion every 2 weeks plus best supportive care as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
|
|---|---|---|
|
Percentage of Participants With Objective Response (Objective Response Rate [ORR])
|
3.4 percentage of participants
Interval 1.5 to 6.5
|
2.6 percentage of participants
Interval 0.5 to 7.3
|
SECONDARY outcome
Timeframe: Randomization up to 17 months post-randomizationPopulation: Zero participants were analyzed. The number of all responders (participants with CR or PR) was too small for a meaningful analysis, as specified in the statistical analysis plan.
DOR is the interval from date of initial documented response (complete response \[CR\] or partial response \[PR\]) to first documented date of disease progression (PD) or death as a result of any cause. CR and PR were defined using the Response Evaluation Criteria in Solid Tumors (RECIST v1.0). CR is defined as the disappearance of all target and non-target lesions, no appearance of new lesions and confirmed at the consecutive tumor assessment. PR is defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, no appearance of new lesions and confirmed at a subsequent tumor assessment. Participants who did not relapse or die were censored at the time of the last adequate objective tumor assessment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to Cycle 10 (18 weeks [1 cycle=2 weeks])Population: All randomized participants with EORTC QLQ-C30 values at baseline and any point up to 18 weeks post-baseline.
EORTC QLQ-C30 v3.0 is a self-administered questionnaire with multidimensional scales that measures 5 functional domains (physical, role, cognitive, emotional, and social), global health status, and symptom scales of fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties. A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For functional domains and global health status, higher scores represent a better level of functioning. For symptoms scales, higher scores represented a greater degree of symptoms. Best change from baseline results determined by Least Square (LS) mean estimated with randomization stratification factors and baseline value as continuous covariate.
Outcome measures
| Measure |
IMC-1121B (Ramucirumab)
n=114 Participants
Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
|
Placebo
n=26 Participants
Participants received placebo by intravenous infusion every 2 weeks plus best supportive care as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in Quality of Life (QoL) as Measured by the European Organisation for Research and Treatment of Cancer Questionnaire (EORTC-QLQ-C30)
Global Health Status/QoL
|
2.42 units on a scale
Standard Error 2.99
|
0.80 units on a scale
Standard Error 4.48
|
|
Change From Baseline in Quality of Life (QoL) as Measured by the European Organisation for Research and Treatment of Cancer Questionnaire (EORTC-QLQ-C30)
Physical Functioning
|
-6.26 units on a scale
Standard Error 3.20
|
-12.01 units on a scale
Standard Error 4.82
|
|
Change From Baseline in Quality of Life (QoL) as Measured by the European Organisation for Research and Treatment of Cancer Questionnaire (EORTC-QLQ-C30)
Role Functioning
|
-4.32 units on a scale
Standard Error 4.65
|
-11.79 units on a scale
Standard Error 6.99
|
|
Change From Baseline in Quality of Life (QoL) as Measured by the European Organisation for Research and Treatment of Cancer Questionnaire (EORTC-QLQ-C30)
Emotional Functioning
|
-1.61 units on a scale
Standard Error 3.29
|
-6.51 units on a scale
Standard Error 4.92
|
|
Change From Baseline in Quality of Life (QoL) as Measured by the European Organisation for Research and Treatment of Cancer Questionnaire (EORTC-QLQ-C30)
Cognitive Functioning
|
-4.26 units on a scale
Standard Error 2.63
|
-10.94 units on a scale
Standard Error 3.94
|
|
Change From Baseline in Quality of Life (QoL) as Measured by the European Organisation for Research and Treatment of Cancer Questionnaire (EORTC-QLQ-C30)
Social Functioning
|
-1.98 units on a scale
Standard Error 3.90
|
-1.37 units on a scale
Standard Error 5.86
|
|
Change From Baseline in Quality of Life (QoL) as Measured by the European Organisation for Research and Treatment of Cancer Questionnaire (EORTC-QLQ-C30)
Fatigue
|
3.16 units on a scale
Standard Error 3.43
|
6.88 units on a scale
Standard Error 5.16
|
|
Change From Baseline in Quality of Life (QoL) as Measured by the European Organisation for Research and Treatment of Cancer Questionnaire (EORTC-QLQ-C30)
Nausea and Vomiting
|
1.77 units on a scale
Standard Error 2.86
|
2.88 units on a scale
Standard Error 4.32
|
|
Change From Baseline in Quality of Life (QoL) as Measured by the European Organisation for Research and Treatment of Cancer Questionnaire (EORTC-QLQ-C30)
Pain
|
0.13 units on a scale
Standard Error 3.61
|
3.85 units on a scale
Standard Error 5.42
|
|
Change From Baseline in Quality of Life (QoL) as Measured by the European Organisation for Research and Treatment of Cancer Questionnaire (EORTC-QLQ-C30)
Dyspnea
|
-2.61 units on a scale
Standard Error 3.35
|
3.51 units on a scale
Standard Error 5.08
|
|
Change From Baseline in Quality of Life (QoL) as Measured by the European Organisation for Research and Treatment of Cancer Questionnaire (EORTC-QLQ-C30)
Insomnia
|
-7.47 units on a scale
Standard Error 4.19
|
-3.95 units on a scale
Standard Error 6.28
|
|
Change From Baseline in Quality of Life (QoL) as Measured by the European Organisation for Research and Treatment of Cancer Questionnaire (EORTC-QLQ-C30)
Appetite Loss
|
-1.01 units on a scale
Standard Error 4.60
|
7.16 units on a scale
Standard Error 6.91
|
|
Change From Baseline in Quality of Life (QoL) as Measured by the European Organisation for Research and Treatment of Cancer Questionnaire (EORTC-QLQ-C30)
Constipation
|
0.09 units on a scale
Standard Error 3.79
|
7.94 units on a scale
Standard Error 5.69
|
|
Change From Baseline in Quality of Life (QoL) as Measured by the European Organisation for Research and Treatment of Cancer Questionnaire (EORTC-QLQ-C30)
Diarrhea
|
-3.97 units on a scale
Standard Error 1.64
|
-5.49 units on a scale
Standard Error 2.46
|
|
Change From Baseline in Quality of Life (QoL) as Measured by the European Organisation for Research and Treatment of Cancer Questionnaire (EORTC-QLQ-C30)
Financial Difficulties
|
-12.86 units on a scale
Standard Error 3.78
|
-2.39 units on a scale
Standard Error 5.68
|
SECONDARY outcome
Timeframe: Randomization up to 18 monthsPopulation: Safety Population: All randomized participants who received at least 1 dose of study drug.
Clinically significant events were defined as serious adverse events (SAE) and other treatment-emergent non-serious adverse events (NSAE). A summary of SAEs and all other NSAEs is located in the Reported Adverse Event module.
Outcome measures
| Measure |
IMC-1121B (Ramucirumab)
n=236 Participants
Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
|
Placebo
n=115 Participants
Participants received placebo by intravenous infusion every 2 weeks plus best supportive care as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
|
|---|---|---|
|
Number of Participants With Adverse Events
Participants with SAE
|
112 participants
|
51 participants
|
|
Number of Participants With Adverse Events
Participants with ≥ 1 treatment emergent NSAE
|
213 participants
|
91 participants
|
SECONDARY outcome
Timeframe: 6 weeks post-randomizationPopulation: Zero participants were analyzed.
Cmax was not analyzed as only pre-dose samples were collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 12 WeeksPopulation: Subset of the Safety Population: All randomized participants who received at least 1 dose of study drug and who had immunogenicity analysis performed.
The number of participants who developed treatment emergent antibody responses to IMC-1121B after baseline.
Outcome measures
| Measure |
IMC-1121B (Ramucirumab)
n=207 Participants
Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
|
Placebo
n=106 Participants
Participants received placebo by intravenous infusion every 2 weeks plus best supportive care as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
|
|---|---|---|
|
Number of Participants Who Developed Antibodies Against IMC-1121B
|
6 participants
|
1 participants
|
Adverse Events
IMC-1121B (Ramucirumab)
Serious events: 112 serious events
Other events: 213 other events
Deaths: 0 deaths
Placebo
Serious events: 51 serious events
Other events: 91 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IMC-1121B (Ramucirumab)
n=236 participants at risk
Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
|
Placebo
n=115 participants at risk
Participants received placebo by intravenous infusion every 2 weeks plus best supportive care as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
|
|---|---|---|
|
Infections and infestations
Pulmonary sepsis
|
0.42%
1/236 • Number of events 1
|
0.00%
0/115
|
|
Infections and infestations
Respiratory tract infection
|
0.42%
1/236 • Number of events 1
|
0.00%
0/115
|
|
Infections and infestations
Sepsis
|
1.3%
3/236 • Number of events 3
|
1.7%
2/115 • Number of events 2
|
|
Infections and infestations
Septic shock
|
0.00%
0/236
|
0.87%
1/115 • Number of events 1
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.85%
2/236 • Number of events 2
|
0.00%
0/115
|
|
Injury, poisoning and procedural complications
Drug dispensing error
|
0.00%
0/236
|
0.87%
1/115 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/236
|
1.7%
2/115 • Number of events 2
|
|
Injury, poisoning and procedural complications
Feeding tube complication
|
0.00%
0/236
|
0.87%
1/115 • Number of events 1
|
|
Injury, poisoning and procedural complications
Incorrect dose administered
|
0.00%
0/236
|
0.87%
1/115 • Number of events 1
|
|
Injury, poisoning and procedural complications
Medication error
|
3.0%
7/236 • Number of events 8
|
0.87%
1/115 • Number of events 2
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.42%
1/236 • Number of events 1
|
0.00%
0/115
|
|
Injury, poisoning and procedural complications
Overdose
|
0.85%
2/236 • Number of events 2
|
0.00%
0/115
|
|
Injury, poisoning and procedural complications
Underdose
|
1.7%
4/236 • Number of events 5
|
0.87%
1/115 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
0.85%
2/236 • Number of events 2
|
0.00%
0/115
|
|
Investigations
Aspartate aminotransferase increased
|
0.85%
2/236 • Number of events 2
|
0.00%
0/115
|
|
Investigations
Blood alkaline phosphatase increased
|
1.7%
4/236 • Number of events 4
|
0.00%
0/115
|
|
Investigations
Blood bilirubin increased
|
0.42%
1/236 • Number of events 1
|
0.00%
0/115
|
|
Investigations
Weight decreased
|
0.42%
1/236 • Number of events 1
|
0.00%
0/115
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.7%
4/236 • Number of events 4
|
0.87%
1/115 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
1.7%
4/236 • Number of events 4
|
2.6%
3/115 • Number of events 3
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.85%
2/236 • Number of events 7
|
0.00%
0/115
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
1.3%
3/236 • Number of events 3
|
0.00%
0/115
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/236
|
0.87%
1/115 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.3%
3/236 • Number of events 3
|
1.7%
2/115 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.42%
1/236 • Number of events 1
|
0.87%
1/115 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.3%
3/236 • Number of events 3
|
0.00%
0/115
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.00%
0/236
|
0.87%
1/115 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
0.42%
1/236 • Number of events 1
|
0.00%
0/115
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/236
|
0.87%
1/115 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.42%
1/236 • Number of events 1
|
0.00%
0/115
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.42%
1/236 • Number of events 1
|
0.00%
0/115
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer recurrent
|
0.42%
1/236 • Number of events 1
|
0.00%
0/115
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/236
|
2.6%
3/115 • Number of events 3
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.42%
1/236 • Number of events 1
|
0.00%
0/115
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/236
|
0.87%
1/115 • Number of events 1
|
|
Blood and lymphatic system disorders
Anaemia
|
4.7%
11/236 • Number of events 11
|
1.7%
2/115 • Number of events 4
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.42%
1/236 • Number of events 1
|
0.00%
0/115
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.42%
1/236 • Number of events 1
|
0.00%
0/115
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/236
|
1.7%
2/115 • Number of events 2
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.42%
1/236 • Number of events 1
|
1.7%
2/115 • Number of events 2
|
|
Cardiac disorders
Cardiac arrest
|
0.42%
1/236 • Number of events 1
|
0.00%
0/115
|
|
Cardiac disorders
Myocardial infarction
|
0.42%
1/236 • Number of events 1
|
0.00%
0/115
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/236
|
0.87%
1/115 • Number of events 1
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.42%
1/236 • Number of events 1
|
0.00%
0/115
|
|
Gastrointestinal disorders
Abdominal distension
|
0.42%
1/236 • Number of events 1
|
0.87%
1/115 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
4.2%
10/236 • Number of events 11
|
2.6%
3/115 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.42%
1/236 • Number of events 1
|
0.00%
0/115
|
|
Gastrointestinal disorders
Ascites
|
2.5%
6/236 • Number of events 6
|
2.6%
3/115 • Number of events 4
|
|
Gastrointestinal disorders
Colonic obstruction
|
0.00%
0/236
|
0.87%
1/115 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/236
|
1.7%
2/115 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/236
|
1.7%
2/115 • Number of events 2
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/236
|
0.87%
1/115 • Number of events 1
|
|
Gastrointestinal disorders
Dysphagia
|
2.5%
6/236 • Number of events 6
|
2.6%
3/115 • Number of events 4
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.42%
1/236 • Number of events 1
|
0.87%
1/115 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.85%
2/236 • Number of events 2
|
1.7%
2/115 • Number of events 3
|
|
Gastrointestinal disorders
Gastrointestinal obstruction
|
0.00%
0/236
|
0.87%
1/115 • Number of events 1
|
|
Gastrointestinal disorders
Haematemesis
|
1.3%
3/236 • Number of events 3
|
0.00%
0/115
|
|
Gastrointestinal disorders
Ileus
|
0.42%
1/236 • Number of events 1
|
0.00%
0/115
|
|
Gastrointestinal disorders
Intestinal obstruction
|
2.1%
5/236 • Number of events 5
|
0.00%
0/115
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.42%
1/236 • Number of events 1
|
0.00%
0/115
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.42%
1/236 • Number of events 1
|
0.87%
1/115 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
1.3%
3/236 • Number of events 3
|
0.00%
0/115
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.85%
2/236 • Number of events 2
|
0.87%
1/115 • Number of events 1
|
|
Gastrointestinal disorders
Oesophageal fistula
|
0.00%
0/236
|
0.87%
1/115 • Number of events 1
|
|
Gastrointestinal disorders
Oesophageal obstruction
|
0.42%
1/236 • Number of events 1
|
0.00%
0/115
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.42%
1/236 • Number of events 1
|
0.00%
0/115
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/236
|
0.87%
1/115 • Number of events 1
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.85%
2/236 • Number of events 3
|
0.00%
0/115
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.42%
1/236 • Number of events 1
|
0.87%
1/115 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
3.0%
7/236 • Number of events 7
|
4.3%
5/115 • Number of events 5
|
|
General disorders
Asthenia
|
0.00%
0/236
|
3.5%
4/115 • Number of events 4
|
|
General disorders
Chest pain
|
0.42%
1/236 • Number of events 1
|
0.00%
0/115
|
|
General disorders
Death
|
2.1%
5/236 • Number of events 5
|
0.00%
0/115
|
|
General disorders
Device dislocation
|
0.00%
0/236
|
0.87%
1/115 • Number of events 1
|
|
General disorders
Disease progression
|
4.2%
10/236 • Number of events 10
|
7.0%
8/115 • Number of events 8
|
|
General disorders
Extravasation
|
0.42%
1/236 • Number of events 1
|
0.00%
0/115
|
|
General disorders
Fatigue
|
0.85%
2/236 • Number of events 2
|
0.87%
1/115 • Number of events 1
|
|
General disorders
General physical health deterioration
|
1.7%
4/236 • Number of events 4
|
0.00%
0/115
|
|
General disorders
Mucosal inflammation
|
0.42%
1/236 • Number of events 1
|
0.00%
0/115
|
|
General disorders
Multi-organ failure
|
2.5%
6/236 • Number of events 6
|
0.87%
1/115 • Number of events 1
|
|
General disorders
Pain
|
0.85%
2/236 • Number of events 2
|
0.00%
0/115
|
|
General disorders
Pyrexia
|
0.00%
0/236
|
0.87%
1/115 • Number of events 1
|
|
General disorders
Sudden death
|
0.00%
0/236
|
0.87%
1/115 • Number of events 1
|
|
General disorders
Systemic inflammatory response syndrome
|
0.42%
1/236 • Number of events 1
|
0.00%
0/115
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.42%
1/236 • Number of events 1
|
0.87%
1/115 • Number of events 1
|
|
Hepatobiliary disorders
Cholangitis
|
0.42%
1/236 • Number of events 1
|
0.87%
1/115 • Number of events 1
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.85%
2/236 • Number of events 2
|
0.00%
0/115
|
|
Hepatobiliary disorders
Cholestasis
|
0.42%
1/236 • Number of events 1
|
0.00%
0/115
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/236
|
0.87%
1/115 • Number of events 1
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.42%
1/236 • Number of events 1
|
0.00%
0/115
|
|
Hepatobiliary disorders
Liver disorder
|
0.42%
1/236 • Number of events 1
|
0.00%
0/115
|
|
Infections and infestations
Abscess
|
0.00%
0/236
|
0.87%
1/115 • Number of events 1
|
|
Infections and infestations
Bacteraemia
|
0.42%
1/236 • Number of events 1
|
0.00%
0/115
|
|
Infections and infestations
Biliary sepsis
|
0.42%
1/236 • Number of events 1
|
0.00%
0/115
|
|
Infections and infestations
Cystitis
|
0.42%
1/236 • Number of events 1
|
0.00%
0/115
|
|
Infections and infestations
Liver abscess
|
0.00%
0/236
|
0.87%
1/115 • Number of events 1
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/236
|
0.87%
1/115 • Number of events 1
|
|
Infections and infestations
Lung infection
|
0.42%
1/236 • Number of events 1
|
0.87%
1/115 • Number of events 1
|
|
Infections and infestations
Peritonitis
|
0.42%
1/236 • Number of events 1
|
0.00%
0/115
|
|
Infections and infestations
Pneumonia
|
1.7%
4/236 • Number of events 4
|
1.7%
2/115 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
|
0.42%
1/236 • Number of events 1
|
0.00%
0/115
|
|
Nervous system disorders
Cerebral ischaemia
|
0.42%
1/236 • Number of events 1
|
0.00%
0/115
|
|
Nervous system disorders
Cerebrovascular accident
|
0.42%
1/236 • Number of events 1
|
0.00%
0/115
|
|
Nervous system disorders
Coma
|
0.42%
1/236 • Number of events 1
|
0.00%
0/115
|
|
Nervous system disorders
Headache
|
0.42%
1/236 • Number of events 1
|
0.00%
0/115
|
|
Nervous system disorders
Hyperammonaemic encephalopathy
|
0.42%
1/236 • Number of events 1
|
0.00%
0/115
|
|
Psychiatric disorders
Confusional state
|
0.42%
1/236 • Number of events 1
|
0.00%
0/115
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/236
|
0.87%
1/115 • Number of events 1
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.85%
2/236 • Number of events 2
|
0.00%
0/115
|
|
Renal and urinary disorders
Renal failure acute
|
0.85%
2/236 • Number of events 2
|
1.7%
2/115 • Number of events 2
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.42%
1/236 • Number of events 1
|
0.00%
0/115
|
|
Renal and urinary disorders
Ureteric perforation
|
0.42%
1/236 • Number of events 1
|
0.00%
0/115
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/236
|
0.87%
1/115 • Number of events 1
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.42%
1/236 • Number of events 1
|
0.00%
0/115
|
|
Reproductive system and breast disorders
Vaginal laceration
|
1.5%
1/67 • Number of events 1
|
0.00%
0/38
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.42%
1/236 • Number of events 1
|
1.7%
2/115 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.42%
1/236 • Number of events 1
|
0.87%
1/115 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.85%
2/236 • Number of events 2
|
1.7%
2/115 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.42%
1/236 • Number of events 1
|
0.00%
0/115
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.42%
1/236 • Number of events 1
|
1.7%
2/115 • Number of events 2
|
|
Surgical and medical procedures
Jejunostomy
|
0.00%
0/236
|
0.87%
1/115 • Number of events 1
|
|
Surgical and medical procedures
Oesophageal stent insertion
|
0.42%
1/236 • Number of events 1
|
0.00%
0/115
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/236
|
2.6%
3/115 • Number of events 3
|
|
Vascular disorders
Embolism
|
0.00%
0/236
|
0.87%
1/115 • Number of events 1
|
|
Vascular disorders
Hypertension
|
0.42%
1/236 • Number of events 1
|
0.00%
0/115
|
|
Vascular disorders
Hypovolaemic shock
|
0.42%
1/236 • Number of events 1
|
0.00%
0/115
|
|
Vascular disorders
Orthostatic hypotension
|
0.42%
1/236 • Number of events 1
|
0.00%
0/115
|
Other adverse events
| Measure |
IMC-1121B (Ramucirumab)
n=236 participants at risk
Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
|
Placebo
n=115 participants at risk
Participants received placebo by intravenous infusion every 2 weeks plus best supportive care as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
14.0%
33/236 • Number of events 41
|
13.9%
16/115 • Number of events 22
|
|
Gastrointestinal disorders
Abdominal pain
|
16.9%
40/236 • Number of events 53
|
22.6%
26/115 • Number of events 36
|
|
Gastrointestinal disorders
Abdominal pain upper
|
11.0%
26/236 • Number of events 35
|
4.3%
5/115 • Number of events 5
|
|
Gastrointestinal disorders
Ascites
|
7.6%
18/236 • Number of events 23
|
7.0%
8/115 • Number of events 8
|
|
Gastrointestinal disorders
Constipation
|
15.7%
37/236 • Number of events 53
|
20.9%
24/115 • Number of events 38
|
|
Gastrointestinal disorders
Diarrhoea
|
14.8%
35/236 • Number of events 64
|
7.8%
9/115 • Number of events 12
|
|
Gastrointestinal disorders
Dyspepsia
|
2.5%
6/236 • Number of events 8
|
6.1%
7/115 • Number of events 7
|
|
Gastrointestinal disorders
Dysphagia
|
9.7%
23/236 • Number of events 33
|
9.6%
11/115 • Number of events 22
|
|
Gastrointestinal disorders
Nausea
|
19.1%
45/236 • Number of events 62
|
26.1%
30/115 • Number of events 44
|
|
Gastrointestinal disorders
Vomiting
|
19.1%
45/236 • Number of events 70
|
22.6%
26/115 • Number of events 36
|
|
General disorders
Asthenia
|
12.7%
30/236 • Number of events 60
|
13.9%
16/115 • Number of events 19
|
|
General disorders
Fatigue
|
24.6%
58/236 • Number of events 90
|
24.3%
28/115 • Number of events 52
|
|
General disorders
Oedema peripheral
|
8.9%
21/236 • Number of events 27
|
8.7%
10/115 • Number of events 11
|
|
Investigations
Weight decreased
|
11.0%
26/236 • Number of events 34
|
9.6%
11/115 • Number of events 13
|
|
Metabolism and nutrition disorders
Decreased appetite
|
23.3%
55/236 • Number of events 90
|
22.6%
26/115 • Number of events 39
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
4.7%
11/236 • Number of events 15
|
5.2%
6/115 • Number of events 6
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.5%
13/236 • Number of events 20
|
4.3%
5/115 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.6%
18/236 • Number of events 22
|
9.6%
11/115 • Number of events 22
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.4%
8/236 • Number of events 11
|
5.2%
6/115 • Number of events 11
|
|
Nervous system disorders
Dizziness
|
1.7%
4/236 • Number of events 6
|
5.2%
6/115 • Number of events 7
|
|
Nervous system disorders
Dysgeusia
|
3.0%
7/236 • Number of events 7
|
5.2%
6/115 • Number of events 9
|
|
Nervous system disorders
Headache
|
8.9%
21/236 • Number of events 28
|
3.5%
4/115 • Number of events 4
|
|
Psychiatric disorders
Insomnia
|
5.5%
13/236 • Number of events 14
|
7.0%
8/115 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.1%
19/236 • Number of events 20
|
7.8%
9/115 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.9%
21/236 • Number of events 24
|
13.0%
15/115 • Number of events 23
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.1%
12/236 • Number of events 15
|
0.87%
1/115 • Number of events 1
|
|
Vascular disorders
Hypertension
|
14.8%
35/236 • Number of events 125
|
7.8%
9/115 • Number of events 31
|
|
Vascular disorders
Hypotension
|
2.1%
5/236 • Number of events 6
|
5.2%
6/115 • Number of events 7
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
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 completion 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