Trial Outcomes & Findings for Glycan Mediated Immune Regulation With a Bi-Sialidase Fusion Protein (GLIMMER-01) (NCT NCT05259696)
NCT ID: NCT05259696
Last Updated: 2025-08-20
Results Overview
Number of participants who experienced an adverse events (AEs) or a serious adverse event (SAE)
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
69 participants
Primary outcome timeframe
15 Months
Results posted on
2025-08-20
Participant Flow
Participant milestones
| Measure |
E-602 1 mg/kg
Participants received 1 mg/kg E-602 monotherapy administered weekly via IV infusion.
|
E-602 3 mg/kg
Participants received 3 mg/kg E-602 monotherapy administered weekly via IV infusion.
|
E-602 10 mg/kg
Participants received 10 mg/kg E-602 monotherapy administered weekly via IV infusion.
|
E-602 20 mg/kg
Participants received 20 mg/kg E-602 monotherapy administered weekly via IV infusion.
|
E-602 30 mg/kg
Participants received 30 mg/kg E-602 monotherapy administered weekly via IV infusion.
|
E-602 20 mg/kg in Combination With Cemiplimab
Participants received 20 mg/kg E-602 monotherapy administered weekly via IV infusion. They also received 350 mg cemiplimab administered every 3 weeks via IV infusion.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
4
|
9
|
15
|
15
|
21
|
|
Overall Study
COMPLETED
|
5
|
4
|
9
|
15
|
15
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Glycan Mediated Immune Regulation With a Bi-Sialidase Fusion Protein (GLIMMER-01)
Baseline characteristics by cohort
| Measure |
E-602 1 mg/kg
n=5 Participants
Participants received 1 mg/kg E-602 monotherapy administered weekly via IV infusion.
|
E-602 3 mg/kg
n=4 Participants
Participants received 3 mg/kg E-602 monotherapy administered weekly via IV infusion.
|
E-602 10 mg/kg
n=9 Participants
Participants received 10 mg/kg E-602 monotherapy administered weekly via IV infusion.
|
E-602 20 mg/kg
n=15 Participants
Participants received 20 mg/kg E-602 monotherapy administered weekly via IV infusion.
|
E-602 30 mg/kg
n=15 Participants
Participants received 30 mg/kg E-602 monotherapy administered weekly via IV infusion.
|
E-602 20 mg/kg in Combination With Cemiplimab
n=21 Participants
Participants received 20 mg/kg E-602 monotherapy administered weekly via IV infusion. They also received 350 mg cemiplimab administered every 3 weeks via IV infusion.
|
Total
n=69 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
57.0 years
STANDARD_DEVIATION 10.79 • n=5 Participants
|
60.0 years
STANDARD_DEVIATION 11.17 • n=7 Participants
|
57.9 years
STANDARD_DEVIATION 12.39 • n=5 Participants
|
59.1 years
STANDARD_DEVIATION 9.36 • n=4 Participants
|
62.1 years
STANDARD_DEVIATION 10.25 • n=21 Participants
|
66.5 years
STANDARD_DEVIATION 10.31 • n=8 Participants
|
61.7 years
STANDARD_DEVIATION 10.67 • n=8 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
36 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
33 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
18 Participants
n=8 Participants
|
56 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 15 MonthsNumber of participants who experienced an adverse events (AEs) or a serious adverse event (SAE)
Outcome measures
| Measure |
E-602 1 mg/kg
n=5 Participants
Participants received 1 mg/kg E-602 monotherapy administered weekly via IV infusion.
|
E-602 3 mg/kg
n=4 Participants
Participants received 3 mg/kg E-602 monotherapy administered weekly via IV infusion.
|
E-602 10 mg/kg
n=9 Participants
Participants received 10 mg/kg E-602 monotherapy administered weekly via IV infusion.
|
E-602 20 mg/kg
n=15 Participants
Participants received 20 mg/kg E-602 monotherapy administered weekly via IV infusion.
|
E-602 30 mg/kg
n=15 Participants
Participants received 30 mg/kg E-602 monotherapy administered weekly via IV infusion.
|
E-602 20 mg/kg in Combination With Cemiplimab
n=21 Participants
Participants received 20 mg/kg E-602 monotherapy administered weekly via IV infusion. They also received 350 mg cemiplimab administered every 3 weeks via IV infusion.
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Experienced AEs or SAEs
Participants with any Treatment Emergent AE
|
5 Participants
|
4 Participants
|
8 Participants
|
15 Participants
|
15 Participants
|
20 Participants
|
|
Number of Participants Who Experienced AEs or SAEs
Participants with any Serious AE
|
3 Participants
|
1 Participants
|
1 Participants
|
6 Participants
|
5 Participants
|
5 Participants
|
Adverse Events
E-602 1 mg/kg
Serious events: 3 serious events
Other events: 5 other events
Deaths: 5 deaths
E-602 3 mg/kg
Serious events: 1 serious events
Other events: 4 other events
Deaths: 1 deaths
E-602 10 mg/kg
Serious events: 1 serious events
Other events: 8 other events
Deaths: 7 deaths
E-602 20 mg/kg
Serious events: 6 serious events
Other events: 15 other events
Deaths: 9 deaths
E-602 30 mg/kg
Serious events: 5 serious events
Other events: 15 other events
Deaths: 6 deaths
E-602 20 mg/kg in Combination With Cemiplimab
Serious events: 5 serious events
Other events: 20 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
E-602 1 mg/kg
n=5 participants at risk
Participants received 1 mg/kg E-602 monotherapy administered weekly via IV infusion.
|
E-602 3 mg/kg
n=4 participants at risk
Participants received 3 mg/kg E-602 monotherapy administered weekly via IV infusion.
|
E-602 10 mg/kg
n=9 participants at risk
Participants received 10 mg/kg E-602 monotherapy administered weekly via IV infusion.
|
E-602 20 mg/kg
n=15 participants at risk
Participants received 20 mg/kg E-602 monotherapy administered weekly via IV infusion.
|
E-602 30 mg/kg
n=15 participants at risk
Participants received 30 mg/kg E-602 monotherapy administered weekly via IV infusion.
|
E-602 20 mg/kg in Combination With Cemiplimab
n=21 participants at risk
Participants received 20 mg/kg E-602 monotherapy administered weekly via IV infusion. They also received 350 mg cemiplimab administered every 3 weeks via IV infusion.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
20.0%
1/5 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/4 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/9 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/21 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/5 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/4 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
11.1%
1/9 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/21 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/5 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/4 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/9 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
6.7%
1/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
6.7%
1/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/21 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/5 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/4 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
11.1%
1/9 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/21 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/5 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/4 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/9 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
6.7%
1/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/21 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
20.0%
1/5 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/4 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/9 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/21 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/5 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/4 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/9 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
6.7%
1/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
4.8%
1/21 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.00%
0/5 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/4 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/9 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
6.7%
1/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/21 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
|
Infections and infestations
Anorectal infection
|
0.00%
0/5 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/4 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/9 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
6.7%
1/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/21 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
|
Infections and infestations
COVID-19
|
20.0%
1/5 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/4 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/9 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/21 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
|
Gastrointestinal disorders
Enterocolitis infectious
|
0.00%
0/5 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/4 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/9 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
6.7%
1/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/21 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
|
Infections and infestations
Pneumonia klebsiella
|
0.00%
0/5 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/4 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
11.1%
1/9 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/21 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
|
Infections and infestations
Sepsis
|
0.00%
0/5 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/4 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/9 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
6.7%
1/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/21 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
|
Infections and infestations
Urinary tract infection
|
20.0%
1/5 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/4 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/9 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/21 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
20.0%
1/5 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/4 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/9 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
6.7%
1/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
4.8%
1/21 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
20.0%
1/5 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/4 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
11.1%
1/9 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
13.3%
2/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
6.7%
1/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
4.8%
1/21 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/5 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/4 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/9 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
13.3%
2/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/21 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/5 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
25.0%
1/4 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/9 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/21 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
|
Renal and urinary disorders
Urinary tract obstruction
|
20.0%
1/5 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/4 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/9 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/21 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/5 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/4 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/9 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
6.7%
1/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
6.7%
1/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/21 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/5 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/4 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/9 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
6.7%
1/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/21 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
|
Vascular disorders
Embolism
|
0.00%
0/5 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/4 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/9 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
6.7%
1/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/21 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.00%
0/5 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/4 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/9 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
4.8%
1/21 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/5 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/4 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/9 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
6.7%
1/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
4.8%
1/21 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
|
General disorders
Pain
|
0.00%
0/5 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/4 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/9 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
4.8%
1/21 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
|
Infections and infestations
Pneumonia
|
0.00%
0/5 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/4 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/9 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
4.8%
1/21 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/5 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/4 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/9 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
4.8%
1/21 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/5 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/4 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/9 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
4.8%
1/21 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
|
Nervous system disorders
Aphasia
|
0.00%
0/5 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/4 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/9 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
4.8%
1/21 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
20.0%
1/5 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/4 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/9 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/21 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
Other adverse events
| Measure |
E-602 1 mg/kg
n=5 participants at risk
Participants received 1 mg/kg E-602 monotherapy administered weekly via IV infusion.
|
E-602 3 mg/kg
n=4 participants at risk
Participants received 3 mg/kg E-602 monotherapy administered weekly via IV infusion.
|
E-602 10 mg/kg
n=9 participants at risk
Participants received 10 mg/kg E-602 monotherapy administered weekly via IV infusion.
|
E-602 20 mg/kg
n=15 participants at risk
Participants received 20 mg/kg E-602 monotherapy administered weekly via IV infusion.
|
E-602 30 mg/kg
n=15 participants at risk
Participants received 30 mg/kg E-602 monotherapy administered weekly via IV infusion.
|
E-602 20 mg/kg in Combination With Cemiplimab
n=21 participants at risk
Participants received 20 mg/kg E-602 monotherapy administered weekly via IV infusion. They also received 350 mg cemiplimab administered every 3 weeks via IV infusion.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
20.0%
1/5 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/4 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
11.1%
1/9 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
40.0%
6/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
33.3%
5/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
4.8%
1/21 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
|
Gastrointestinal disorders
Abdominal pain
|
60.0%
3/5 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
25.0%
1/4 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/9 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
13.3%
2/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
26.7%
4/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
9.5%
2/21 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
|
Gastrointestinal disorders
Vomiting
|
40.0%
2/5 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/4 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
22.2%
2/9 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
6.7%
1/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
20.0%
3/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
9.5%
2/21 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
|
Gastrointestinal disorders
Constipation
|
20.0%
1/5 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/4 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/9 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
26.7%
4/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
6.7%
1/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
19.0%
4/21 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
|
Gastrointestinal disorders
Nausea
|
60.0%
3/5 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/4 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
11.1%
1/9 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
6.7%
1/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
6.7%
1/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
28.6%
6/21 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
|
Gastrointestinal disorders
Diarrhoea
|
20.0%
1/5 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/4 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/9 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
6.7%
1/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
20.0%
3/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
19.0%
4/21 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
|
General disorders
Fatigue
|
20.0%
1/5 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
25.0%
1/4 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
33.3%
3/9 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
20.0%
3/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
26.7%
4/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
33.3%
7/21 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
|
Infections and infestations
Urinary tract infection
|
20.0%
1/5 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
25.0%
1/4 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
22.2%
2/9 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
4.8%
1/21 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/5 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/4 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
11.1%
1/9 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
13.3%
2/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
9.5%
2/21 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/5 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
25.0%
1/4 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
55.6%
5/9 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
66.7%
10/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
66.7%
10/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
42.9%
9/21 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/5 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/4 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
11.1%
1/9 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
20.0%
3/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
13.3%
2/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
4.8%
1/21 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/5 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/4 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
11.1%
1/9 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
20.0%
3/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
6.7%
1/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
4.8%
1/21 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/5 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/4 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
11.1%
1/9 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
26.7%
4/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
4.8%
1/21 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/5 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/4 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/9 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
13.3%
2/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
13.3%
2/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/21 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/5 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/4 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/9 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
20.0%
3/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
4.8%
1/21 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
20.0%
1/5 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/4 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
11.1%
1/9 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
26.7%
4/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
20.0%
3/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
9.5%
2/21 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/5 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/4 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/9 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
13.3%
2/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
20.0%
3/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/21 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
|
Metabolism and nutrition disorders
Decreased appetite
|
20.0%
1/5 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/4 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/9 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
13.3%
2/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
6.7%
1/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
14.3%
3/21 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/5 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
25.0%
1/4 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/9 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
6.7%
1/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
13.3%
2/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
4.8%
1/21 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/5 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/4 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/9 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
13.3%
2/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
13.3%
2/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
9.5%
2/21 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
|
Metabolism and nutrition disorders
Dehydration
|
20.0%
1/5 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/4 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
22.2%
2/9 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
4.8%
1/21 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/5 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
25.0%
1/4 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/9 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
13.3%
2/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
13.3%
2/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
9.5%
2/21 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
20.0%
1/5 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/4 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
11.1%
1/9 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
6.7%
1/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
6.7%
1/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
4.8%
1/21 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
|
Nervous system disorders
Headache
|
0.00%
0/5 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/4 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
11.1%
1/9 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
6.7%
1/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
6.7%
1/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
4.8%
1/21 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
|
Vascular disorders
Hypertension
|
0.00%
0/5 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/4 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/9 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
20.0%
3/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
20.0%
3/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/21 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
|
Infections and infestations
COVID-19
|
20.0%
1/5 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/4 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
11.1%
1/9 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
14.3%
3/21 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/5 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
25.0%
1/4 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/9 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
6.7%
1/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
14.3%
3/21 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/5 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/4 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/9 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
6.7%
1/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
33.3%
7/21 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/5 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/4 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/9 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
0.00%
0/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
6.7%
1/15 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
19.0%
4/21 • Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.
Adverse Events were graded using CTCAE v5.0
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER