Trial Outcomes & Findings for Phase I/II Study of SBRT and GC4711 for Centrally Located or Large NSCLC (NCT NCT04476797)
NCT ID: NCT04476797
Last Updated: 2024-04-30
Results Overview
Subjects were required to have a baseline CT (chest, abdomen, and pelvis) and then were re-assessed by the same imaging modality at 6 months, 12 months, 18 months, and 24 months following the administration of GC4711/Placebo +SBRT and compared to the previous best response using RECIST 1.1 criteria.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
47 participants
Primary outcome timeframe
6 months, 12 months, 18 months and 24 months post SBRT and GC4711+Placebo
Results posted on
2024-04-30
Participant Flow
Participant milestones
| Measure |
Phase 1
Subjects in Phase 1 received 100mg of GC4711 by 15 min IV prior to each administration of SBRT. SBRT was administered as a dose of 10-12 Gy per fraction in a total of 5 fractions within 10 calendar days.
|
Phase 2 Placebo +SBRT
Subjects in Phase 2 received Placebo by a 15 min IV prior to each administration of SBRT. SBRT was administered as a dose of 10-12 Gy per fraction in a total of 5 fractions within 10 calendar days.
|
Phase 2 GC4711 +SBRT
Subjects in Phase 2 received 100mg of GC4711 by 15 min IV prior to each administration of SBRT. SBRT was administered as a dose of 10-12 Gy per fraction in a total of 5 fractions within 10 calendar days.
|
|---|---|---|---|
|
Overall Study
STARTED
|
7
|
20
|
20
|
|
Overall Study
COMPLETED
|
6
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
1
|
19
|
19
|
Reasons for withdrawal
| Measure |
Phase 1
Subjects in Phase 1 received 100mg of GC4711 by 15 min IV prior to each administration of SBRT. SBRT was administered as a dose of 10-12 Gy per fraction in a total of 5 fractions within 10 calendar days.
|
Phase 2 Placebo +SBRT
Subjects in Phase 2 received Placebo by a 15 min IV prior to each administration of SBRT. SBRT was administered as a dose of 10-12 Gy per fraction in a total of 5 fractions within 10 calendar days.
|
Phase 2 GC4711 +SBRT
Subjects in Phase 2 received 100mg of GC4711 by 15 min IV prior to each administration of SBRT. SBRT was administered as a dose of 10-12 Gy per fraction in a total of 5 fractions within 10 calendar days.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
|
Overall Study
Death
|
0
|
1
|
2
|
|
Overall Study
Sponsor Terminated Study
|
0
|
18
|
17
|
Baseline Characteristics
Phase I/II Study of SBRT and GC4711 for Centrally Located or Large NSCLC
Baseline characteristics by cohort
| Measure |
Phase 1
n=7 Participants
Subjects in Phase 1 received 100mg of GC4711 by 15 min IV prior to each administration of SBRT. SBRT was administered as a dose of 10-12 Gy per fraction in a total of 5 fractions within 10 calendar days.
|
Phase 2 Placebo +SBRT
n=20 Participants
Subjects in Phase 2 received 100mg of Placebo by 15 min IV prior to each administration of SBRT. SBRT was administered as a dose of 10-12 Gy per fraction in a total of 5 fractions within 10 calendar days.
|
Phase 2 GC4711 +SBRT
n=20 Participants
Subjects in Phase 2 received 100mg of GC4711 by 15 min IV prior to each administration of SBRT. SBRT was administered as a dose of 10-12 Gy per fraction in a total of 5 fractions within 10 calendar days.
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
< 65
|
3 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
|
Age, Customized
>/= 65
|
4 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
34 Participants
n=7 Participants
|
|
Age, Customized
65-74
|
2 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
|
Age, Customized
>/=75
|
2 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
16 Participants
n=7 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
19 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
28 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 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
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
38 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 6 months, 12 months, 18 months and 24 months post SBRT and GC4711+PlaceboPopulation: Intent to Treat population includes all subjects enrolled/randomized to the study.
Subjects were required to have a baseline CT (chest, abdomen, and pelvis) and then were re-assessed by the same imaging modality at 6 months, 12 months, 18 months, and 24 months following the administration of GC4711/Placebo +SBRT and compared to the previous best response using RECIST 1.1 criteria.
Outcome measures
| Measure |
Phase 1
n=7 Participants
Subjects in Phase 1 received 100mg of GC4711 by 15 min IV prior to each administration of SBRT. SBRT was administered as a dose of 10-12 Gy per fraction in a total of 5 fractions within 10 calendar days.
|
Phase 2 Placebo +SBRT
n=20 Participants
Subjects in Phase 2 received Placebo by a 15 min IV prior to each administration of SBRT. SBRT was administered as a dose of 10-12 Gy per fraction in a total of 5 fractions within 10 calendar days.
|
Phase 2 GC4711 +SBRT
n=20 Participants
Subjects in Phase 2 received 100mg of GC4711 by 15 min IV prior to each administration of SBRT. SBRT was administered as a dose of 10-12 Gy per fraction in a total of 5 fractions within 10 calendar days.
|
|---|---|---|---|
|
Percent of Patients With a Complete Response or Partial In-field Tumor Response Based on the RECIST 1.1 Criteria Through 6 Months Following SBRT.
CR-Complete Response
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Percent of Patients With a Complete Response or Partial In-field Tumor Response Based on the RECIST 1.1 Criteria Through 6 Months Following SBRT.
PR-Partial Response
|
2 Participants
|
6 Participants
|
6 Participants
|
|
Percent of Patients With a Complete Response or Partial In-field Tumor Response Based on the RECIST 1.1 Criteria Through 6 Months Following SBRT.
SD-Stable Disease
|
5 Participants
|
4 Participants
|
6 Participants
|
|
Percent of Patients With a Complete Response or Partial In-field Tumor Response Based on the RECIST 1.1 Criteria Through 6 Months Following SBRT.
PD-Progressive Disease
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Percent of Patients With a Complete Response or Partial In-field Tumor Response Based on the RECIST 1.1 Criteria Through 6 Months Following SBRT.
NE-Not Evaluable
|
0 Participants
|
10 Participants
|
7 Participants
|
Adverse Events
Phase 1
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Phase 2 Placebo +SBRT
Serious events: 1 serious events
Other events: 20 other events
Deaths: 1 deaths
Phase 2 GC4711 +SBRT
Serious events: 1 serious events
Other events: 19 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Phase 1
n=7 participants at risk
Subjects in Phase 1 received 100mg of GC4711 by 15 min IV prior to each administration of SBRT. SBRT was administered as a dose of 10-12 Gy per fraction in a total of 5 fractions within 10 calendar days.
|
Phase 2 Placebo +SBRT
n=20 participants at risk
Subjects in Phase 2 received Placebo by a 15 min IV prior to each administration of SBRT. SBRT was administered as a dose of 10-12 Gy per fraction in a total of 5 fractions within 10 calendar days.
|
Phase 2 GC4711 +SBRT
n=20 participants at risk
Subjects in Phase 2 received 100mg of GC4711 by 15 min IV prior to each administration of SBRT. SBRT was administered as a dose of 10-12 Gy per fraction in a total of 5 fractions within 10 calendar days.
|
|---|---|---|---|
|
Cardiac disorders
Cardiac Arrest
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Cardiac disorders
Pericardial Effusion
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Infections and infestations
Pneumonia
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Infections and infestations
Sepsis
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Nervous system disorders
Cerebrovascular accident
|
14.3%
1/7 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
Other adverse events
| Measure |
Phase 1
n=7 participants at risk
Subjects in Phase 1 received 100mg of GC4711 by 15 min IV prior to each administration of SBRT. SBRT was administered as a dose of 10-12 Gy per fraction in a total of 5 fractions within 10 calendar days.
|
Phase 2 Placebo +SBRT
n=20 participants at risk
Subjects in Phase 2 received Placebo by a 15 min IV prior to each administration of SBRT. SBRT was administered as a dose of 10-12 Gy per fraction in a total of 5 fractions within 10 calendar days.
|
Phase 2 GC4711 +SBRT
n=20 participants at risk
Subjects in Phase 2 received 100mg of GC4711 by 15 min IV prior to each administration of SBRT. SBRT was administered as a dose of 10-12 Gy per fraction in a total of 5 fractions within 10 calendar days.
|
|---|---|---|---|
|
Investigations
Neutrophil count increased
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
10.0%
2/20 • Number of events 2 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Eye disorders
Vision blurred
|
14.3%
1/7 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
10.0%
2/20 • Number of events 2 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Blood and lymphatic system disorders
Anemia
|
14.3%
1/7 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
10.0%
2/20 • Number of events 2 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Blood and lymphatic system disorders
Eosinophilia
|
14.3%
1/7 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Blood and lymphatic system disorders
Haemorrhagic diathesis
|
14.3%
1/7 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Blood and lymphatic system disorders
Increased tendency to bruise
|
14.3%
1/7 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Blood and lymphatic system disorders
Leuckocytosis
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Cardiac disorders
Bradycardia
|
14.3%
1/7 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Cardiac disorders
Palpitations
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Eye disorders
Photophobia
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Eye disorders
Photopsia
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Eye disorders
Retinal Vascular Disorder
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Eye disorders
Vision Impairment
|
14.3%
1/7 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Eye disorders
Vitreous floaters
|
14.3%
1/7 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Gastrointestinal disorders
Abdominal Pain
|
28.6%
2/7 • Number of events 2 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
14.3%
1/7 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Gastrointestinal disorders
Constipation
|
28.6%
2/7 • Number of events 2 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Gastrointestinal disorders
Diarrhoea
|
42.9%
3/7 • Number of events 3 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
15.0%
3/20 • Number of events 3 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
10.0%
2/20 • Number of events 2 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Gastrointestinal disorders
Dry Mouth
|
14.3%
1/7 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
15.0%
3/20 • Number of events 3 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Gastrointestinal disorders
Eructation
|
28.6%
2/7 • Number of events 2 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
28.6%
2/7 • Number of events 2 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
10.0%
2/20 • Number of events 2 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Gastrointestinal disorders
Nausea
|
71.4%
5/7 • Number of events 5 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
25.0%
5/20 • Number of events 5 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
45.0%
9/20 • Number of events 9 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Gastrointestinal disorders
Oesophageal disorder
|
14.3%
1/7 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Gastrointestinal disorders
Oral dysaesthesia
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
1/7 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
15.0%
3/20 • Number of events 3 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
General disorders
Axillary Pain
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
General disorders
Chest Discomfort
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
General disorders
Chills
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
10.0%
2/20 • Number of events 2 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
General disorders
Fatigue
|
85.7%
6/7 • Number of events 6 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
50.0%
10/20 • Number of events 10 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
55.0%
11/20 • Number of events 11 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
General disorders
Feeling Hot
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
General disorders
Gait Disturbance
|
14.3%
1/7 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Investigations
Blood Chloride decreased
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
General disorders
Infusion Site Discomfort
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
General disorders
Infusion Site Erythema
|
14.3%
1/7 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
General disorders
Infusion Site Pain
|
14.3%
1/7 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
General disorders
Infusion Site Swelling
|
14.3%
1/7 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
General disorders
Injection Site Pain
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
General disorders
Injection site reaction
|
14.3%
1/7 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
General disorders
Localised Oedema
|
14.3%
1/7 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
General disorders
Non Cardiac Chest Pain
|
28.6%
2/7 • Number of events 2 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
10.0%
2/20 • Number of events 2 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
10.0%
2/20 • Number of events 2 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
General disorders
Oedema Peripheral
|
14.3%
1/7 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
General disorders
Pain
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
10.0%
2/20 • Number of events 2 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Infections and infestations
COVID 19
|
14.3%
1/7 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Infections and infestations
Pneumonia
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Infections and infestations
Tooth Infection
|
14.3%
1/7 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Injury, poisoning and procedural complications
Contusion
|
14.3%
1/7 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
10.0%
2/20 • Number of events 2 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Injury, poisoning and procedural complications
Fall
|
14.3%
1/7 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
15.0%
3/20 • Number of events 3 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Injury, poisoning and procedural complications
Radiation Associated Pain
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Injury, poisoning and procedural complications
Radiation Skin Injury
|
14.3%
1/7 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
14.3%
1/7 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Investigations
Alanine aminotransferase increased
|
14.3%
1/7 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Investigations
Aspartate aminotransferase increased
|
14.3%
1/7 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Investigations
Blood alkaline phosphatase increased
|
14.3%
1/7 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Investigations
Blood Creatinine increased
|
14.3%
1/7 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Investigations
Glomerular filtration rate decreased
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Investigations
Heart Rate Increased
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Investigations
High Density Lipoprotein decreased
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Investigations
International Normalised ratio Increased
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Investigations
Lymphocyte count decreased
|
14.3%
1/7 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
25.0%
5/20 • Number of events 5 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Investigations
Monocyte count Increased
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Investigations
Platelet Count Decreased
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
10.0%
2/20 • Number of events 2 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Investigations
Red Blood Cell Increased
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Investigations
Serum Ferritin Increased
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Investigations
Weight Decreased
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Investigations
White Blood Cell Count Decreased
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Investigations
White Blood Cell Increased
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
10.0%
2/20 • Number of events 2 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
15.0%
3/20 • Number of events 3 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
10.0%
2/20 • Number of events 2 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Metabolism and nutrition disorders
Dehydration
|
28.6%
2/7 • Number of events 2 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Metabolism and nutrition disorders
Hyperalbuminaemia
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
14.3%
1/7 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
10.0%
2/20 • Number of events 2 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
42.9%
3/7 • Number of events 3 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
28.6%
2/7 • Number of events 2 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
10.0%
2/20 • Number of events 2 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
14.3%
1/7 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Musculoskeletal and connective tissue disorders
Joint Stiffness
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Musculoskeletal and connective tissue disorders
Metatarsalgia
|
14.3%
1/7 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
14.3%
1/7 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
10.0%
2/20 • Number of events 2 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
15.0%
3/20 • Number of events 3 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
10.0%
2/20 • Number of events 2 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
10.0%
2/20 • Number of events 2 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
14.3%
1/7 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
10.0%
2/20 • Number of events 2 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Musculoskeletal and connective tissue disorders
Plantar Fasciitis
|
14.3%
1/7 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Nervous system disorders
Dizziness
|
28.6%
2/7 • Number of events 2 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
10.0%
2/20 • Number of events 2 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
40.0%
8/20 • Number of events 8 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Nervous system disorders
Essential tremor
|
14.3%
1/7 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Nervous system disorders
Headache
|
28.6%
2/7 • Number of events 2 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
15.0%
3/20 • Number of events 3 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
20.0%
4/20 • Number of events 4 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Nervous system disorders
Paraesthesia
|
42.9%
3/7 • Number of events 3 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
25.0%
5/20 • Number of events 5 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Nervous system disorders
Sciatica
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Nervous system disorders
Sedation
|
14.3%
1/7 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Nervous system disorders
Somnolence
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Nervous system disorders
Taste Disorder
|
14.3%
1/7 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Psychiatric disorders
Confusional State
|
14.3%
1/7 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Renal and urinary disorders
Glycosuria
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Renal and urinary disorders
Nephrolithiasis
|
14.3%
1/7 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Renal and urinary disorders
Urinary Tract Obstruction
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Respiratory, thoracic and mediastinal disorders
Nipple Pain
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
57.1%
4/7 • Number of events 4 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
30.0%
6/20 • Number of events 6 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
10.0%
2/20 • Number of events 2 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
42.9%
3/7 • Number of events 3 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
45.0%
9/20 • Number of events 9 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
25.0%
5/20 • Number of events 5 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
14.3%
1/7 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
42.9%
3/7 • Number of events 3 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
30.0%
6/20 • Number of events 6 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
14.3%
1/7 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Fibrosis
|
42.9%
3/7 • Number of events 3 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
20.0%
4/20 • Number of events 4 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
14.3%
1/7 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Skin and subcutaneous tissue disorders
Skin Tightness
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
10.0%
2/20 • Number of events 2 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Vascular disorders
Flushing
|
14.3%
1/7 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Vascular disorders
Hot Flash
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Vascular disorders
Hypertension
|
0.00%
0/7 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
0.00%
0/20 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
10.0%
2/20 • Number of events 2 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
|
Vascular disorders
Hypotension
|
42.9%
3/7 • Number of events 3 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
20.0%
4/20 • Number of events 4 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
20.0%
4/20 • Number of events 4 • All adverse events were collected from Day 1 of dosing with GC4711/Placebo +SBRT through 90 days post SBRT (Total of 3.5 months)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60