NCT06048367 · ADVERSE EVENTS

Adverse events

Carbon Nanoparticle-Loaded Iron [CNSI-Fe(II)] in the Treatment of Advanced Solid Tumor · Source last updated 2025-08-03

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
CNSI-Fe(II) 30 mg 30 mg CNSI-Fe(II) 30 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. Five dose groups are planned \[based on Fe(II)\]: 30 mg, 60 mg, 90 mg, 120 mg and 150 mg. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The corresponding dose will be administered by intratumoral injection, with the injection volume determined according to the size of the injection lesion.	1 / 3	3 / 3	0 / 3
CNSI-Fe(II) 60 mg 60 mg CNSI-Fe(II) 60 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. Five dose groups are planned \[based on Fe(II)\]: 30 mg, 60 mg, 90 mg, 120 mg and 150 mg. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The corresponding dose will be administered by intratumoral injection, with the injection volume determined according to the size of the injection lesion.	1 / 4	4 / 4	0 / 4
CNSI-Fe(II) 90 mg 90 mg CNSI-Fe(II) 90 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. Five dose groups are planned \[based on Fe(II)\]: 30 mg, 60 mg, 90 mg, 120 mg and 150 mg. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The corresponding dose will be administered by intratumoral injection, with the injection volume determined according to the size of the injection lesion.	5 / 6	6 / 6	2 / 6
CNSI-Fe(II) 120 mg 120 mg CNSI-Fe(II) 120 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. Five dose groups are planned \[based on Fe(II)\]: 30 mg, 60 mg, 90 mg, 120 mg and 150 mg. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The corresponding dose will be administered by intratumoral injection, with the injection volume determined according to the size of the injection lesion.	0 / 3	3 / 3	0 / 3
CNSI-Fe(II) 150 mg 150 mg CNSI-Fe(II) 150 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. Five dose groups are planned \[based on Fe(II)\]: 30 mg, 60 mg, 90 mg, 120 mg and 150 mg. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The corresponding dose will be administered by intratumoral injection, with the injection volume determined according to the size of the injection lesion.	1 / 3	3 / 3	0 / 3

Group identifiers: EG000: CNSI-Fe(II) 30 mg · EG001: CNSI-Fe(II) 60 mg · EG002: CNSI-Fe(II) 90 mg · EG003: CNSI-Fe(II) 120 mg · EG004: CNSI-Fe(II) 150 mg

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
term
abdominal wall abscess
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
3
num Events
1
term
pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
term
focal peritonitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
term
oral infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
3
num At Risk
6
num Events
3
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
term
malignant tumor progression
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
2
num At Risk
6
num Events
2
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
term
cancer pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
term
pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
term
weakness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
term
injection site reaction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
term
injection site pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
term
colonic fistula
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
term
emesis

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Surgical and medical procedures
stats
group Id
EG000
num Affected
3
num At Risk
3
num Events
3
group Id
EG001
num Affected
4
num At Risk
4
num Events
5
group Id
EG002
num Affected
5
num At Risk
6
num Events
6
group Id
EG003
num Affected
3
num At Risk
3
num Events
3
group Id
EG004
num Affected
2
num At Risk
3
num Events
2
term
injection site pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
2
num At Risk
4
num Events
4
group Id
EG002
num Affected
3
num At Risk
6
num Events
4
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
3
num Events
1
term
weak
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
3
num At Risk
6
num Events
4
group Id
EG003
num Affected
2
num At Risk
3
num Events
3
group Id
EG004
num Affected
1
num At Risk
3
num Events
3
term
fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
3
num Events
1
term
pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Surgical and medical procedures
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
2
num At Risk
4
num Events
2
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
term
injection site swelling
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Surgical and medical procedures
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
2
num At Risk
6
num Events
2
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
term
injection site reaction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
2
num At Risk
6
num Events
2
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
term
Facial edema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
3
num Events
1
term
Peripheral edema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
term
stethalgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
1
num At Risk
3
num Events
1
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
term
foreign body sensation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Surgical and medical procedures
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
term
Injection site warmth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
3
group Id
EG001
num Affected
2
num At Risk
4
num Events
3
group Id
EG002
num Affected
2
num At Risk
6
num Events
3
group Id
EG003
num Affected
2
num At Risk
3
num Events
2
group Id
EG004
num Affected
3
num At Risk
3
num Events
3
term
elevation of blood pressure

Complete source fields

event Groups

deaths Num Affected
0
deaths Num At Risk
3
description
30 mg CNSI-Fe(II) 30 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. Five dose groups are planned \[based on Fe(II)\]: 30 mg, 60 mg, 90 mg, 120 mg and 150 mg. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The corresponding dose will be administered by intratumoral injection, with the injection volume determined according to the size of the injection lesion.
id
EG000
other Num Affected
3
other Num At Risk
3
serious Num Affected
1
serious Num At Risk
3
title
CNSI-Fe(II) 30 mg
deaths Num Affected
0
deaths Num At Risk
4
description
60 mg CNSI-Fe(II) 60 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. Five dose groups are planned \[based on Fe(II)\]: 30 mg, 60 mg, 90 mg, 120 mg and 150 mg. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The corresponding dose will be administered by intratumoral injection, with the injection volume determined according to the size of the injection lesion.
id
EG001
other Num Affected
4
other Num At Risk
4
serious Num Affected
1
serious Num At Risk
4
title
CNSI-Fe(II) 60 mg
deaths Num Affected
2
deaths Num At Risk
6
description
90 mg CNSI-Fe(II) 90 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. Five dose groups are planned \[based on Fe(II)\]: 30 mg, 60 mg, 90 mg, 120 mg and 150 mg. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The corresponding dose will be administered by intratumoral injection, with the injection volume determined according to the size of the injection lesion.
id
EG002
other Num Affected
6
other Num At Risk
6
serious Num Affected
5
serious Num At Risk
6
title
CNSI-Fe(II) 90 mg
deaths Num Affected
0
deaths Num At Risk
3
description
120 mg CNSI-Fe(II) 120 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. Five dose groups are planned \[based on Fe(II)\]: 30 mg, 60 mg, 90 mg, 120 mg and 150 mg. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The corresponding dose will be administered by intratumoral injection, with the injection volume determined according to the size of the injection lesion.
id
EG003
other Num Affected
3
other Num At Risk
3
serious Num Affected
0
serious Num At Risk
3
title
CNSI-Fe(II) 120 mg
deaths Num Affected
0
deaths Num At Risk
3
description
150 mg CNSI-Fe(II) 150 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. Five dose groups are planned \[based on Fe(II)\]: 30 mg, 60 mg, 90 mg, 120 mg and 150 mg. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The corresponding dose will be administered by intratumoral injection, with the injection volume determined according to the size of the injection lesion.
id
EG004
other Num Affected
3
other Num At Risk
3
serious Num Affected
1
serious Num At Risk
3
title
CNSI-Fe(II) 150 mg

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Surgical and medical procedures
stats
group Id
EG000
num Affected
3
num At Risk
3
num Events
3
group Id
EG001
num Affected
4
num At Risk
4
num Events
5
group Id
EG002
num Affected
5
num At Risk
6
num Events
6
group Id
EG003
num Affected
3
num At Risk
3
num Events
3
group Id
EG004
num Affected
2
num At Risk
3
num Events
2
term
injection site pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
2
num At Risk
4
num Events
4
group Id
EG002
num Affected
3
num At Risk
6
num Events
4
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
3
num Events
1
term
weak
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
3
num At Risk
6
num Events
4
group Id
EG003
num Affected
2
num At Risk
3
num Events
3
group Id
EG004
num Affected
1
num At Risk
3
num Events
3
term
fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
3
num Events
1
term
pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Surgical and medical procedures
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
2
num At Risk
4
num Events
2
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
term
injection site swelling
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Surgical and medical procedures
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
2
num At Risk
6
num Events
2
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
term
injection site reaction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
2
num At Risk
6
num Events
2
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
term
Facial edema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
3
num Events
1
term
Peripheral edema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
term
stethalgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
1
num At Risk
3
num Events
1
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
term
foreign body sensation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Surgical and medical procedures
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
term
Injection site warmth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
3
group Id
EG001
num Affected
2
num At Risk
4
num Events
3
group Id
EG002
num Affected
2
num At Risk
6
num Events
3
group Id
EG003
num Affected
2
num At Risk
3
num Events
2
group Id
EG004
num Affected
3
num At Risk
3
num Events
3
term
elevation of blood pressure

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
term
abdominal wall abscess
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
3
num Events
1
term
pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
term
focal peritonitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
term
oral infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
3
num At Risk
6
num Events
3
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
term
malignant tumor progression
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
2
num At Risk
6
num Events
2
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
term
cancer pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
term
pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
term
weakness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
term
injection site reaction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
term
injection site pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
term
colonic fistula
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
term
emesis

time Frame

From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.

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Preserved source evidence · Not medical advice