Carbon Nanoparticle-Loaded Iron [CNSI-Fe(II)] in the Treatment of Advanced Solid Tumor

Draft scope assessment: unclear. Attached because the study's own record describes locally advanced disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

This primary outcome measure is centered on the assessment of CNSI-Fe(II)'s safety and tolerability throughout the study. It encompasses the following assessments: Dose-Limiting Toxicity (DLT): This assessment involves the ongoing monitoring of adverse events, with a focus on determining their nature, severity, and frequency. Adverse events will be systematically categorized and reported according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Maximum Tolerated Dose (MTD): The MTD is a critical outcome measure representing the highest injectable dose in humans that can be safely administered without causing excessive adverse effects. The determination of MTD will be based on the careful observation and analysis of DLT data. The MTD was not determined in this Phase I study, and the MAD is 150mg. Units of Measure: DLT: Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0. MTD: Milligrams (mg) of CNSI-Fe(II).

Source null

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secondary · POSTED

This secondary outcome measure focuses on assessing the pharmacokinetic (PK) profile of CNSI-Fe(II) in patients with advanced solid tumors. Assessment Details: PK Parameters Assessment: This assessment involves the analysis of the drug's absorption, distribution, metabolism, and excretion (ADME) in patients. It will provide insights into how CNSI-Fe(II) behaves in the human body. The first assessed parameter is maximum plasma concentration (Cmax). Cmax of first dosage Units of Measure: Cmax: Nanograms per milliliter (ng/mL) (serum iron ion concentrations changes from baseline)

Source null

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secondary · POSTED

This secondary outcome measure focuses on assessing the pharmacokinetic (PK) profile of CNSI-Fe(II) in patients with advanced solid tumors. Assessment Details: PK Parameters Assessment: This assessment involves the analysis of the drug's absorption, distribution, metabolism, and excretion (ADME) in patients. It will provide insights into how CNSI-Fe(II) behaves in the human body. The second assessed parameter is time to maximum plasma concentration (Tmax). Tmax of first dosage Units of Measure: Tmax: Hours (h)

Source null

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secondary · POSTED

This secondary outcome measure focuses on assessing the pharmacokinetic (PK) profile of CNSI-Fe(II) in patients with advanced solid tumors. Assessment Details: PK Parameters Assessment: This assessment involves the analysis of the drug's absorption, distribution, metabolism, and excretion (ADME) in patients. It will provide insights into how CNSI-Fe(II) behaves in the human body. The third assessed parameter is area under the concentration-time curve (AUC). AUC of first dosage Units of Measure: AUC: Nanograms per hour per milliliter (ng•h/mL)

Source null

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secondary · POSTED

This secondary outcome measure focuses on assessing the pharmacokinetic (PK) profile of CNSI-Fe(II) in patients with advanced solid tumors. Assessment Details: PK Parameters Assessment: This assessment involves the analysis of the drug's absorption, distribution, metabolism, and excretion (ADME) in patients. It will provide insights into how CNSI-Fe(II) behaves in the human body. The fourth assessed parameter is elimination half-life (t1/2). t1/2 of first dosage Units of Measure: t1/2: Hours (h)

Source null

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secondary · POSTED

Complete Response (CR): According to the modified Response Evaluation Criteria in Solid Tumors (RECIST v1.1) (lesions treated with local injection are defined as target lesions, and lesions not treated with local injection are defined as non-target lesions), target lesions are evaluated by contrast-enhanced CT/MRI. All target lesions must disappear, and the short diameter of all pathological lymph nodes must decrease to \<10 mm.

Source null

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Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-cervical-cancer-keytruda-d88e44f2
nct id: NCT06048367
trial label: Carbon Nanoparticle-Loaded Iron [CNSI-Fe(II)] in the Treatment of Advanced Solid Tumor
applicability: unclear
applicability note: Attached because the study's own record describes locally advanced disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 6
harms Count: 5
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-keytruda-d88e44f2
nct id
NCT06048367
outcome key
om-0000
source section id
NCT06048367-om-0000
source outcome index
0
endpoint
Safety and Tolerability Assessment of CNSI-Fe(II)
endpoint definition
This primary outcome measure is centered on the assessment of CNSI-Fe(II)'s safety and tolerability throughout the study. It encompasses the following assessments: Dose-Limiting Toxicity (DLT): This assessment involves the ongoing monitoring of adverse events, with a focus on determining their nature, severity, and frequency. Adverse events will be systematically categorized and reported according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Maximum Tolerated Dose (MTD): The MTD is a critical outcome measure representing the highest injectable dose in humans that can be safely administered without causing excessive adverse effects. The determination of MTD will be based on the careful observation and analysis of DLT data. The MTD was not determined in this Phase I study, and the MAD is 150mg. Units of Measure: DLT: Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0. MTD: Milligrams (mg) of CNSI-Fe(II).
time origin
21 days
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-keytruda-d88e44f2
nct id
NCT06048367
outcome key
om-0001
source section id
NCT06048367-om-0001
source outcome index
1
endpoint
PK Parameters Assessment: Cmax (ng/mL) Profile Assessment of CNSI-Fe(II) of First Dosage
endpoint definition
This secondary outcome measure focuses on assessing the pharmacokinetic (PK) profile of CNSI-Fe(II) in patients with advanced solid tumors. Assessment Details: PK Parameters Assessment: This assessment involves the analysis of the drug's absorption, distribution, metabolism, and excretion (ADME) in patients. It will provide insights into how CNSI-Fe(II) behaves in the human body. The first assessed parameter is maximum plasma concentration (Cmax). Cmax of first dosage Units of Measure: Cmax: Nanograms per milliliter (ng/mL) (serum iron ion concentrations changes from baseline)
time origin
72 h
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-keytruda-d88e44f2
nct id
NCT06048367
outcome key
om-0002
source section id
NCT06048367-om-0002
source outcome index
2
endpoint
PK Parameters Assessment: Tmax (h) Profile Assessment of CNSI-Fe(II) of First Dosage
endpoint definition
This secondary outcome measure focuses on assessing the pharmacokinetic (PK) profile of CNSI-Fe(II) in patients with advanced solid tumors. Assessment Details: PK Parameters Assessment: This assessment involves the analysis of the drug's absorption, distribution, metabolism, and excretion (ADME) in patients. It will provide insights into how CNSI-Fe(II) behaves in the human body. The second assessed parameter is time to maximum plasma concentration (Tmax). Tmax of first dosage Units of Measure: Tmax: Hours (h)
time origin
72 h
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-keytruda-d88e44f2
nct id
NCT06048367
outcome key
om-0003
source section id
NCT06048367-om-0003
source outcome index
3
endpoint
PK Parameters Assessment: AUC (ng•h/mL) Profile Assessment of CNSI-Fe(II) of First Dosage
endpoint definition
This secondary outcome measure focuses on assessing the pharmacokinetic (PK) profile of CNSI-Fe(II) in patients with advanced solid tumors. Assessment Details: PK Parameters Assessment: This assessment involves the analysis of the drug's absorption, distribution, metabolism, and excretion (ADME) in patients. It will provide insights into how CNSI-Fe(II) behaves in the human body. The third assessed parameter is area under the concentration-time curve (AUC). AUC of first dosage Units of Measure: AUC: Nanograms per hour per milliliter (ng•h/mL)
time origin
72 h
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-keytruda-d88e44f2
nct id
NCT06048367
outcome key
om-0004
source section id
NCT06048367-om-0004
source outcome index
4
endpoint
PK Parameters Assessment: t1/2 (h) Profile Assessment of CNSI-Fe(II) of First Dosage
endpoint definition
This secondary outcome measure focuses on assessing the pharmacokinetic (PK) profile of CNSI-Fe(II) in patients with advanced solid tumors. Assessment Details: PK Parameters Assessment: This assessment involves the analysis of the drug's absorption, distribution, metabolism, and excretion (ADME) in patients. It will provide insights into how CNSI-Fe(II) behaves in the human body. The fourth assessed parameter is elimination half-life (t1/2). t1/2 of first dosage Units of Measure: t1/2: Hours (h)
time origin
72 h
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-keytruda-d88e44f2
nct id
NCT06048367
outcome key
om-0005
source section id
NCT06048367-om-0005
source outcome index
5
endpoint
Evaluated as CR (Complete Response) in the Preliminary Efficacy Assessment.
endpoint definition
Complete Response (CR): According to the modified Response Evaluation Criteria in Solid Tumors (RECIST v1.1) (lesions treated with local injection are defined as target lesions, and lesions not treated with local injection are defined as non-target lesions), target lesions are evaluated by contrast-enhanced CT/MRI. All target lesions must disappear, and the short diameter of all pathological lymph nodes must decrease to \<10 mm.
time origin
Observation period for a single dose is 21~28 days, the observation period for two doses is doubled.
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-keytruda-d88e44f2
nct id
NCT06048367
outcome key
om-0000
arm key
OG000
arm label
CNSI-Fe(II) 30 mg
regimen
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. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT06048367-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-keytruda-d88e44f2
nct id
NCT06048367
outcome key
om-0000
arm key
OG001
arm label
CNSI-Fe(II) 60 mg
regimen
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. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT06048367-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-keytruda-d88e44f2
nct id
NCT06048367
outcome key
om-0000
arm key
OG002
arm label
CNSI-Fe(II) 90 mg
regimen
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. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT06048367-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-keytruda-d88e44f2
nct id
NCT06048367
outcome key
om-0000
arm key
OG003
arm label
CNSI-Fe(II) 120 mg
regimen
120 mg CNSI-Fe(II) 120 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT06048367-om-0000#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-keytruda-d88e44f2
nct id
NCT06048367
outcome key
om-0000
arm key
OG004
arm label
CNSI-Fe(II) 150 mg
regimen
150 mg CNSI-Fe(II) 150 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT06048367-om-0000#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-keytruda-d88e44f2
nct id
NCT06048367
outcome key
om-0001
arm key
OG000
arm label
CNSI-Fe(II) 30 mg
regimen
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. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT06048367-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-keytruda-d88e44f2
nct id
NCT06048367
outcome key
om-0001
arm key
OG001
arm label
CNSI-Fe(II) 60 mg
regimen
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. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.
analyzed count
4
analyzed unit
Participants
is comparator
Source null
source pointer
NCT06048367-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-keytruda-d88e44f2
nct id
NCT06048367
outcome key
om-0001
arm key
OG002
arm label
CNSI-Fe(II) 90 mg
regimen
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. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT06048367-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-keytruda-d88e44f2
nct id
NCT06048367
outcome key
om-0001
arm key
OG003
arm label
CNSI-Fe(II) 120 mg
regimen
120 mg CNSI-Fe(II) 120 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT06048367-om-0001#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-keytruda-d88e44f2
nct id
NCT06048367
outcome key
om-0001
arm key
OG004
arm label
CNSI-Fe(II) 150 mg
regimen
150 mg CNSI-Fe(II) 150 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT06048367-om-0001#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-keytruda-d88e44f2
nct id
NCT06048367
outcome key
om-0002
arm key
OG000
arm label
CNSI-Fe(II) 30 mg
regimen
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. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT06048367-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-keytruda-d88e44f2
nct id
NCT06048367
outcome key
om-0002
arm key
OG001
arm label
CNSI-Fe(II) 60 mg
regimen
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. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.
analyzed count
4
analyzed unit
Participants
is comparator
Source null
source pointer
NCT06048367-om-0002#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-keytruda-d88e44f2
nct id
NCT06048367
harm key
EG000
source section id
NCT06048367-ae
event group key
EG000
event group label
CNSI-Fe(II) 30 mg
serious affected
1
serious at risk
3
other affected
3
other at risk
3
frequency threshold
5
collection period
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.
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-keytruda-d88e44f2
nct id
NCT06048367
harm key
EG001
source section id
NCT06048367-ae
event group key
EG001
event group label
CNSI-Fe(II) 60 mg
serious affected
1
serious at risk
4
other affected
4
other at risk
4
frequency threshold
5
collection period
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.
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-keytruda-d88e44f2
nct id
NCT06048367
harm key
EG002
source section id
NCT06048367-ae
event group key
EG002
event group label
CNSI-Fe(II) 90 mg
serious affected
5
serious at risk
6
other affected
6
other at risk
6
frequency threshold
5
collection period
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.
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-keytruda-d88e44f2
nct id
NCT06048367
harm key
EG003
source section id
NCT06048367-ae
event group key
EG003
event group label
CNSI-Fe(II) 120 mg
serious affected
0
serious at risk
3
other affected
3
other at risk
3
frequency threshold
5
collection period
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.
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-keytruda-d88e44f2
nct id
NCT06048367
harm key
EG004
source section id
NCT06048367-ae
event group key
EG004
event group label
CNSI-Fe(II) 150 mg
serious affected
1
serious at risk
3
other affected
3
other at risk
3
frequency threshold
5
collection period
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.
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice