Trial Outcomes & Findings for Phase 2b Study of GC4711 in Combination With SBRT for Nonmetastatic Pancreatic Cancer (NCT NCT04698915)
NCT ID: NCT04698915
Last Updated: 2024-05-21
Results Overview
Overall survival is defined as the time from randomization to the date of death from any cause. The number of subjects that have died during this time period is the reported outcome measure.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
177 participants
Primary outcome timeframe
From randomization of the first subject until 30 days post last dose of GC4711/ and SBRT for the last subject randomized to the study (total duration 2years and 6.5 months)
Results posted on
2024-05-21
Participant Flow
Participant milestones
| Measure |
Arm A Active GC4711
Drug GC4711: 15 Minute IV Infusion
|
Arm B Placebo
Placebo: 15 Minute IV Infusion
|
|---|---|---|
|
Overall Study
STARTED
|
84
|
84
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
84
|
84
|
Reasons for withdrawal
| Measure |
Arm A Active GC4711
Drug GC4711: 15 Minute IV Infusion
|
Arm B Placebo
Placebo: 15 Minute IV Infusion
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
|
Overall Study
Death
|
23
|
20
|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Study Terminated by Sponsor
|
55
|
60
|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
Baseline Characteristics
Phase 2b Study of GC4711 in Combination With SBRT for Nonmetastatic Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
Arm A Active GC4711
n=84 Participants
Drug GC4711: 15 Minute IV Infusion
|
Arm B Placebo
n=84 Participants
Placebo: 15 Minute IV Infusion
|
Total
n=168 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
36 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
74 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
48 Participants
n=99 Participants
|
46 Participants
n=107 Participants
|
94 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
86 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
82 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
70 Participants
n=99 Participants
|
67 Participants
n=107 Participants
|
137 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: From randomization of the first subject until 30 days post last dose of GC4711/ and SBRT for the last subject randomized to the study (total duration 2years and 6.5 months)Population: Modified Intent to Treat Population that includes all randomized subjects that received at least one dose of GC4711/Placebo.
Overall survival is defined as the time from randomization to the date of death from any cause. The number of subjects that have died during this time period is the reported outcome measure.
Outcome measures
| Measure |
Arm A Active GC4711
n=84 Participants
Drug GC4711: 15 Minute IV Infusion
|
Arm B Placebo
n=84 Participants
Placebo: 15 Minute IV Infusion
|
|---|---|---|
|
Overall Survival
|
24 Participants
|
20 Participants
|
Adverse Events
Arm A Active GC4711
Serious events: 17 serious events
Other events: 76 other events
Deaths: 24 deaths
Arm B Placebo
Serious events: 14 serious events
Other events: 71 other events
Deaths: 20 deaths
Serious adverse events
| Measure |
Arm A Active GC4711
n=84 participants at risk
Drug GC4711: 15 Minute IV Infusion
|
Arm B Placebo
n=84 participants at risk
Placebo: 15 Minute IV Infusion
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/84 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
1.2%
1/84 • Number of events 1 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
1.2%
1/84 • Number of events 1 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
0.00%
0/84 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/84 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
1.2%
1/84 • Number of events 1 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
|
Gastrointestinal disorders
Diarrhoea
|
1.2%
1/84 • Number of events 1 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
1.2%
1/84 • Number of events 1 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
|
Gastrointestinal disorders
Duodenal Stenosis
|
1.2%
1/84 • Number of events 1 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
0.00%
0/84 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
|
Gastrointestinal disorders
Fistula of Small Intestine
|
1.2%
1/84 • Number of events 1 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
0.00%
0/84 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/84 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
1.2%
1/84 • Number of events 1 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
|
Gastrointestinal disorders
Haematochezia
|
1.2%
1/84 • Number of events 1 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
0.00%
0/84 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
|
Gastrointestinal disorders
Mesenteric Vein Thrombosis
|
0.00%
0/84 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
1.2%
1/84 • Number of events 1 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/84 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
1.2%
1/84 • Number of events 1 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
|
Gastrointestinal disorders
Upper Gastrointestinal Haemorrhage
|
0.00%
0/84 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
1.2%
1/84 • Number of events 1 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
|
General disorders
Generalised Oedema
|
1.2%
1/84 • Number of events 1 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
0.00%
0/84 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
|
General disorders
Pyrexia
|
2.4%
2/84 • Number of events 2 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
0.00%
0/84 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
|
General disorders
Systemic Inflammatory Response Syndrome
|
1.2%
1/84 • Number of events 1 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
0.00%
0/84 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
|
Hepatobiliary disorders
Bile Duct Obstruction
|
1.2%
1/84 • Number of events 1 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
1.2%
1/84 • Number of events 1 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
|
Hepatobiliary disorders
Bile Duct Stenosis
|
1.2%
1/84 • Number of events 1 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
0.00%
0/84 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
|
Hepatobiliary disorders
Cholangitis
|
1.2%
1/84 • Number of events 1 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
0.00%
0/84 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/84 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
1.2%
1/84 • Number of events 1 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
|
Hepatobiliary disorders
Jaundice
|
1.2%
1/84 • Number of events 1 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
0.00%
0/84 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
|
Infections and infestations
Bacteraemia
|
1.2%
1/84 • Number of events 1 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
1.2%
1/84 • Number of events 1 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
|
Infections and infestations
Cholecystitis Infective
|
0.00%
0/84 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
1.2%
1/84 • Number of events 1 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
|
Infections and infestations
Clostridium difficile colititis
|
1.2%
1/84 • Number of events 1 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
0.00%
0/84 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
|
Infections and infestations
Sepsis
|
4.8%
4/84 • Number of events 4 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
2.4%
2/84 • Number of events 2 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
|
Injury, poisoning and procedural complications
Peripancreatic fluid Collection
|
1.2%
1/84 • Number of events 1 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
0.00%
0/84 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
1.2%
1/84 • Number of events 1 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
0.00%
0/84 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
|
Investigations
Blood Bilirubin Increased
|
2.4%
2/84 • Number of events 2 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
2.4%
2/84 • Number of events 2 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/84 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
1.2%
1/84 • Number of events 1 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
1.2%
1/84 • Number of events 1 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
0.00%
0/84 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic Neoplasm
|
0.00%
0/84 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
1.2%
1/84 • Number of events 1 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic Carcinoma
|
0.00%
0/84 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
1.2%
1/84 • Number of events 1 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic Carcinoma Metastatic
|
0.00%
0/84 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
2.4%
2/84 • Number of events 2 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
|
Nervous system disorders
Cerebrovascular accident
|
1.2%
1/84 • Number of events 1 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
0.00%
0/84 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
|
Nervous system disorders
Headache
|
0.00%
0/84 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
1.2%
1/84 • Number of events 1 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
|
Nervous system disorders
Syncope
|
2.4%
2/84 • Number of events 2 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
0.00%
0/84 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
|
Product Issues
Device Occlusion
|
0.00%
0/84 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
1.2%
1/84 • Number of events 1 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
|
Psychiatric disorders
Confusional State
|
0.00%
0/84 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
1.2%
1/84 • Number of events 1 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/84 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
1.2%
1/84 • Number of events 1 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
|
Vascular disorders
Lymphatic Fistula
|
0.00%
0/84 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
1.2%
1/84 • Number of events 1 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
Other adverse events
| Measure |
Arm A Active GC4711
n=84 participants at risk
Drug GC4711: 15 Minute IV Infusion
|
Arm B Placebo
n=84 participants at risk
Placebo: 15 Minute IV Infusion
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
4.8%
4/84 • Number of events 4 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
9.5%
8/84 • Number of events 8 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
|
Gastrointestinal disorders
Abdominal Distension
|
8.3%
7/84 • Number of events 7 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
9.5%
8/84 • Number of events 8 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
|
Gastrointestinal disorders
Abdominal Pain
|
19.0%
16/84 • Number of events 16 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
19.0%
16/84 • Number of events 16 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
6.0%
5/84 • Number of events 5 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
1.2%
1/84 • Number of events 1 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
|
Gastrointestinal disorders
Constipation
|
9.5%
8/84 • Number of events 8 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
9.5%
8/84 • Number of events 8 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
|
Gastrointestinal disorders
Diarrhoea
|
17.9%
15/84 • Number of events 15 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
15.5%
13/84 • Number of events 13 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
|
Gastrointestinal disorders
Dyspepsia
|
6.0%
5/84 • Number of events 5 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
1.2%
1/84 • Number of events 1 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
|
Gastrointestinal disorders
Flatulence
|
6.0%
5/84 • Number of events 5 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
4.8%
4/84 • Number of events 4 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
|
Gastrointestinal disorders
Nausea
|
52.4%
44/84 • Number of events 44 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
38.1%
32/84 • Number of events 32 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
|
Gastrointestinal disorders
Vomiting
|
31.0%
26/84 • Number of events 26 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
17.9%
15/84 • Number of events 15 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
|
General disorders
Fatigue
|
45.2%
38/84 • Number of events 38 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
31.0%
26/84 • Number of events 26 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
|
Investigations
Alanine aminotransferase increased
|
6.0%
5/84 • Number of events 5 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
4.8%
4/84 • Number of events 4 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
|
Investigations
Aspartate aminotransferase increased
|
8.3%
7/84 • Number of events 7 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
6.0%
5/84 • Number of events 5 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
|
Investigations
Blood alkaline phosphatase increased
|
11.9%
10/84 • Number of events 10 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
4.8%
4/84 • Number of events 4 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
|
Investigations
Blood Bilirubin Increased
|
6.0%
5/84 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
1.2%
1/84 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
|
Investigations
Lymphocyte count decreased
|
9.5%
8/84 • Number of events 8 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
3.6%
3/84 • Number of events 3 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
|
Investigations
Platelet Count Decreased
|
4.8%
4/84 • Number of events 4 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
7.1%
6/84 • Number of events 6 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
|
Investigations
White Blood Cell Count Decreased
|
6.0%
5/84 • Number of events 5 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
3.6%
3/84 • Number of events 3 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
7.1%
6/84 • Number of events 6 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
10.7%
9/84 • Number of events 9 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
|
Nervous system disorders
Dizziness
|
17.9%
15/84 • Number of events 15 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
7.1%
6/84 • Number of events 6 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
|
Nervous system disorders
Headache
|
9.5%
8/84 • Number of events 8 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
4.8%
4/84 • Number of events 4 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
|
Nervous system disorders
Paraesthesia
|
9.5%
8/84 • Number of events 8 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
4.8%
4/84 • Number of events 4 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
|
Psychiatric disorders
Insomnia
|
6.0%
5/84 • Number of events 5 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
2.4%
2/84 • Number of events 2 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
|
Vascular disorders
Hypertension
|
9.5%
8/84 • Number of events 8 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
11.9%
10/84 • Number of events 10 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
|
Vascular disorders
Hypotension
|
21.4%
18/84 • Number of events 18 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
3.6%
3/84 • Number of events 3 • All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months)
|
Additional Information
Judy Schnyder, Sr. Vice President Clinical Operations and Data Management
Galera Therapeutics
Phone: 484-870-9625
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60