Trial Outcomes & Findings for ROMAN: Phase 3 Trial Investigating the Effects of GC4419 on Radiation Induced Oral Mucositis in Head/Neck Cancer Patients (NCT NCT03689712)
NCT ID: NCT03689712
Last Updated: 2023-10-24
Results Overview
Cumulative incidence of severe oral mucositis is defined as the proportion of subjects with any occurrence of WHO Grade 3 to 4 OM, during the Study Treatment Period. Incidence of severe OM is defined as any occurrence of WHO Grade 3 or 4 OM through the last IMRT fraction after the start of IMRT. Incidence was imputed using multiple imputation for subjects with incomplete follow-up for severe OM through 60 Gy who did not have an occurrence of severe OM before the last IMRT fraction.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
455 participants
Primary outcome timeframe
From the first IMRT fraction through the end of the study treatment period (completion of study drug administration, IMRT and chemotherapy), which is estimated to be 7 weeks.
Results posted on
2023-10-24
Participant Flow
Participant milestones
| Measure |
GC4419 (Avasopasem Manganese) 90 mg
GC4419 (avasopasem manganese): 60 minute IV infusion
|
Placebo
Placebo: 60 minute IV infusion
|
|---|---|---|
|
Overall Study
STARTED
|
270
|
185
|
|
Overall Study
Intent to Treat Population
|
241
|
166
|
|
Overall Study
COMPLETED
|
105
|
74
|
|
Overall Study
NOT COMPLETED
|
165
|
111
|
Reasons for withdrawal
| Measure |
GC4419 (Avasopasem Manganese) 90 mg
GC4419 (avasopasem manganese): 60 minute IV infusion
|
Placebo
Placebo: 60 minute IV infusion
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Death
|
20
|
10
|
|
Overall Study
Lost to Follow-up
|
6
|
6
|
|
Overall Study
Other
|
1
|
0
|
|
Overall Study
Patient Non-Compliance
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
20
|
4
|
|
Overall Study
Patients Continuing in Long Term Follow Up
|
88
|
71
|
|
Overall Study
Randomized but not Treated
|
13
|
7
|
|
Overall Study
Subject Dosing Suspended due to Product Issue
|
16
|
12
|
Baseline Characteristics
ROMAN: Phase 3 Trial Investigating the Effects of GC4419 on Radiation Induced Oral Mucositis in Head/Neck Cancer Patients
Baseline characteristics by cohort
| Measure |
GC4419 (Avasopasem Manganese)
n=241 Participants
GC4419 (avasopasem manganese): 60 minute IV infusion
|
Placebo
n=166 Participants
Placebo: 60 minute IV infusion
|
Total
n=407 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
|
163 Participants
n=99 Participants
|
111 Participants
n=107 Participants
|
274 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
78 Participants
n=99 Participants
|
55 Participants
n=107 Participants
|
133 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
56 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
202 Participants
n=99 Participants
|
149 Participants
n=107 Participants
|
351 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
222 Participants
n=99 Participants
|
160 Participants
n=107 Participants
|
382 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
219 Participants
n=99 Participants
|
158 Participants
n=107 Participants
|
377 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Region of Enrollment
Canada
|
33 participants
n=99 Participants
|
24 participants
n=107 Participants
|
57 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
208 participants
n=99 Participants
|
142 participants
n=107 Participants
|
350 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: From the first IMRT fraction through the end of the study treatment period (completion of study drug administration, IMRT and chemotherapy), which is estimated to be 7 weeks.Population: The Intent to treat population consisted of all randomized subjects who received at least 1 dose of avasopasem manganese or placebo (with the exception of subjects whose treatment course was discontinued due to the sponsor's voluntary suspension of dosing)
Cumulative incidence of severe oral mucositis is defined as the proportion of subjects with any occurrence of WHO Grade 3 to 4 OM, during the Study Treatment Period. Incidence of severe OM is defined as any occurrence of WHO Grade 3 or 4 OM through the last IMRT fraction after the start of IMRT. Incidence was imputed using multiple imputation for subjects with incomplete follow-up for severe OM through 60 Gy who did not have an occurrence of severe OM before the last IMRT fraction.
Outcome measures
| Measure |
GC4419 (Avasopasem Manganese) 90mg
n=241 Participants
GC4419: 60 minute IV infusion
|
Placebo
n=166 Participants
Placebo: 60 minute IV infusion
|
|---|---|---|
|
Cumulative Incidence of Severe Oral Mucositis
|
53.8 percentage of patients
|
64.0 percentage of patients
|
Adverse Events
GC4419 (Avasopasem Manganese) 90 mg
Serious events: 81 serious events
Other events: 240 other events
Deaths: 20 deaths
Placebo
Serious events: 52 serious events
Other events: 166 other events
Deaths: 10 deaths
Serious adverse events
| Measure |
GC4419 (Avasopasem Manganese) 90 mg
n=241 participants at risk
GC4419 90mg: 60 minute IV infusion
|
Placebo
n=166 participants at risk
Placebo: 60 minute IV infusion
|
|---|---|---|
|
Investigations
Lipase Increased
|
0.41%
1/241 • Number of events 1 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
0.00%
0/166 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to Peritoneum
|
0.41%
1/241 • Number of events 1 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
0.00%
0/166 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle Haemorrhage
|
0.00%
0/241 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
0.60%
1/166 • Number of events 1 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.41%
1/241 • Number of events 1 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
0.00%
0/166 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
Infections and infestations
Neutropenic Sepsis
|
0.41%
1/241 • Number of events 1 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
0.00%
0/166 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
6.2%
15/241 • Number of events 17 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
4.8%
8/166 • Number of events 9 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
2.9%
7/241 • Number of events 8 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
1.8%
3/166 • Number of events 3 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
Infections and infestations
Sepsis
|
1.7%
4/241 • Number of events 4 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
2.4%
4/166 • Number of events 5 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
Metabolism and nutrition disorders
Failure to Thrive
|
1.2%
3/241 • Number of events 3 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
3.6%
6/166 • Number of events 6 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
2.9%
7/241 • Number of events 7 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
1.2%
2/166 • Number of events 2 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
1.2%
3/241 • Number of events 7 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
0.60%
1/166 • Number of events 1 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.41%
1/241 • Number of events 1 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
3.0%
5/166 • Number of events 7 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
Gastrointestinal disorders
Nausea
|
2.1%
5/241 • Number of events 5 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
1.2%
2/166 • Number of events 2 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
General disorders
Pyrexia
|
2.5%
6/241 • Number of events 6 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
0.00%
0/166 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
Gastrointestinal disorders
Vomiting
|
1.7%
4/241 • Number of events 4 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
3.6%
6/166 • Number of events 6 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
Cardiac disorders
Atrial Fibrillation
|
0.41%
1/241 • Number of events 1 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
1.2%
2/166 • Number of events 3 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/241 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
0.60%
1/166 • Number of events 3 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
Gastrointestinal disorders
Dysphagia
|
1.2%
3/241 • Number of events 3 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
1.2%
2/166 • Number of events 4 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
Infections and infestations
Lung Infection
|
0.83%
2/241 • Number of events 2 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
1.2%
2/166 • Number of events 2 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
General disorders
Asethenia
|
0.41%
1/241 • Number of events 1 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
1.2%
2/166 • Number of events 2 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.83%
2/241 • Number of events 2 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
0.60%
1/166 • Number of events 1 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.83%
2/241 • Number of events 2 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
0.60%
1/166 • Number of events 1 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
Product Issues
Device Malfunction
|
1.2%
3/241 • Number of events 3 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
0.00%
0/166 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
Vascular disorders
Hypotension
|
1.2%
3/241 • Number of events 3 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
0.00%
0/166 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.83%
2/241 • Number of events 2 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
0.60%
1/166 • Number of events 1 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.83%
2/241 • Number of events 2 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
0.60%
1/166 • Number of events 1 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
Gastrointestinal disorders
Pancreatitis
|
0.41%
1/241 • Number of events 1 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
1.2%
2/166 • Number of events 2 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia Aspiration
|
0.83%
2/241 • Number of events 2 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
0.60%
1/166 • Number of events 1 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.00%
0/241 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
0.60%
1/166 • Number of events 2 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
Cardiac disorders
Cardiac failure congestive
|
0.83%
2/241 • Number of events 2 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
0.00%
0/166 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.41%
1/241 • Number of events 2 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
0.00%
0/166 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
Gastrointestinal disorders
Constipation
|
0.83%
2/241 • Number of events 2 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
0.00%
0/166 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
Infections and infestations
Hepatitis viral
|
0.83%
2/241 • Number of events 2 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
0.00%
0/166 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/241 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
1.2%
2/166 • Number of events 2 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
General disorders
Non-Cardiac Chest Pain
|
0.41%
1/241 • Number of events 1 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
0.60%
1/166 • Number of events 1 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
Gastrointestinal disorders
Odynophagia
|
0.41%
1/241 • Number of events 1 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
0.60%
1/166 • Number of events 1 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
Investigations
Weight Decreased
|
0.00%
0/241 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
1.2%
2/166 • Number of events 2 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
Infections and infestations
Abdominal Wall Abscess
|
0.41%
1/241 • Number of events 1 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
0.00%
0/166 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
Injury, poisoning and procedural complications
Accidental Overdose
|
0.41%
1/241 • Number of events 1 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
0.00%
0/166 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
Cardiac disorders
Acute myocardial infarction
|
0.41%
1/241 • Number of events 1 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
0.00%
0/166 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
Infections and infestations
Bactaraemia
|
0.00%
0/241 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
0.60%
1/166 • Number of events 1 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
Infections and infestations
Bronchitis
|
0.41%
1/241 • Number of events 1 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
0.00%
0/166 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
Cardiac disorders
Cardiac Arrest
|
0.41%
1/241 • Number of events 1 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
0.00%
0/166 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
Cardiac disorders
Cardio-respiratory Arrest
|
0.41%
1/241 • Number of events 1 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
0.00%
0/166 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.00%
0/241 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
0.60%
1/166 • Number of events 1 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
Infections and infestations
Corona Virus Infection
|
0.00%
0/241 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
0.60%
1/166 • Number of events 1 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
General disorders
Death
|
0.41%
1/241 • Number of events 1 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
0.00%
0/166 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
Psychiatric disorders
Delirium
|
0.41%
1/241 • Number of events 1 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
0.00%
0/166 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
Psychiatric disorders
Depression
|
0.41%
1/241 • Number of events 1 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
0.00%
0/166 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
Product Issues
Device Occulsion
|
0.41%
1/241 • Number of events 1 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
0.00%
0/166 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
Infections and infestations
Device Related Infection
|
0.00%
0/241 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
0.60%
1/166 • Number of events 1 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
0.41%
1/241 • Number of events 1 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
0.00%
0/166 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
Metabolism and nutrition disorders
Euglycaemic Diabetic Ketoacidosis
|
0.00%
0/241 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
0.60%
1/166 • Number of events 1 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
Surgical and medical procedures
Gastrostomy Tube Removal
|
0.41%
1/241 • Number of events 1 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
0.00%
0/166 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
Injury, poisoning and procedural complications
Gastrostomy Tube Site Complication
|
0.41%
1/241 • Number of events 1 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
0.00%
0/166 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/241 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
0.60%
1/166 • Number of events 1 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
Gastrointestinal disorders
Haemorrhoidal Haemorrhage
|
0.41%
1/241 • Number of events 1 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
0.00%
0/166 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
Blood and lymphatic system disorders
Hypercoagulation
|
0.00%
0/241 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
0.60%
1/166 • Number of events 1 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.41%
1/241 • Number of events 1 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
0.00%
0/166 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.41%
1/241 • Number of events 1 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
0.00%
0/166 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/241 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
0.60%
1/166 • Number of events 1 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.41%
1/241 • Number of events 1 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
0.00%
0/166 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal Oedema
|
0.00%
0/241 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
0.60%
1/166 • Number of events 1 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
Infections and infestations
Oropharyngeal Candidiasis
|
0.41%
1/241 • Number of events 1 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
0.00%
0/166 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
Infections and infestations
Parotitis
|
0.41%
1/241 • Number of events 1 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
0.00%
0/166 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
Nervous system disorders
Presyncope
|
0.41%
1/241 • Number of events 1 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
0.00%
0/166 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
Cardiac disorders
Sinus Bradycardia
|
0.41%
1/241 • Number of events 1 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
0.00%
0/166 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
0.41%
1/241 • Number of events 1 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
0.00%
0/166 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
Infections and infestations
Staphylococcal Sepsis
|
0.00%
0/241 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
0.60%
1/166 • Number of events 1 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
Infections and infestations
Stoma Site Infection
|
0.41%
1/241 • Number of events 1 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
0.00%
0/166 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
Nervous system disorders
Syncope
|
0.00%
0/241 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
0.60%
1/166 • Number of events 1 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
Nervous system disorders
Tremor
|
0.00%
0/241 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
0.60%
1/166 • Number of events 1 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour Haemorrhage
|
0.41%
1/241 • Number of events 1 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
0.00%
0/166 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
Gastrointestinal disorders
Upper Gastrointestinal Haemorrhage
|
0.00%
0/241 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
0.60%
1/166 • Number of events 1 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/241 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
0.60%
1/166 • Number of events 1 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
Other adverse events
| Measure |
GC4419 (Avasopasem Manganese) 90 mg
n=241 participants at risk
GC4419 90mg: 60 minute IV infusion
|
Placebo
n=166 participants at risk
Placebo: 60 minute IV infusion
|
|---|---|---|
|
Blood and lymphatic system disorders
Lymphopenia
|
88.0%
212/241 • Number of events 465 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
93.4%
155/166 • Number of events 329 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
Gastrointestinal disorders
Nausea
|
85.9%
207/241 • Number of events 449 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
82.5%
137/166 • Number of events 319 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
60.6%
146/241 • Number of events 280 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
68.1%
113/166 • Number of events 251 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
General disorders
Fatigue
|
70.5%
170/241 • Number of events 278 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
74.7%
124/166 • Number of events 238 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
Gastrointestinal disorders
Constipation
|
63.9%
154/241 • Number of events 236 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
61.4%
102/166 • Number of events 194 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
Injury, poisoning and procedural complications
Radiation Skin Injury
|
52.3%
126/241 • Number of events 222 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
62.7%
104/166 • Number of events 181 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
Gastrointestinal disorders
Vomiting
|
56.0%
135/241 • Number of events 259 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
46.4%
77/166 • Number of events 137 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
Investigations
Weight Decreased
|
48.1%
116/241 • Number of events 222 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
48.2%
80/166 • Number of events 148 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
Nervous system disorders
Paresthesia
|
14.9%
36/241 • Number of events 212 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
9.0%
15/166 • Number of events 41 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
Nervous system disorders
Dysgeusia
|
56.8%
137/241 • Number of events 192 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
71.7%
119/166 • Number of events 167 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
|
Gastrointestinal disorders
Dry Mouth
|
53.5%
129/241 • Number of events 163 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
62.7%
104/166 • Number of events 152 • Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A copy of the proposed manuscript (or other document) for publication, presentation or other disclosure must be forwarded to the sponsor not less than 30 days prior to submission or presentation and the Principal Investigator shall comply with Sponsor's requests to delete or revise references to Confidential Information and consider all other comments of Sponsor in good faith.
- Publication restrictions are in place
Restriction type: OTHER