NCT03686215 · ADVERSE EVENTS

Adverse events

Investigation of Novel Surgical Imaging for Tumor Excision · Source last updated 2023-08-24

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: All adverse events and adverse device effects, both serious and non-serious, and deaths that are encountered from initiation of study intervention, throughout the study, and within the first post-operative follow-up visit should be followed to their resolution, or until the principal investigator assesses them as stable, or the principal investigator determines the event to be irreversible, or the subject is lost to follow-up. Adverse events were assessed up to 30 days after enrollment.
Other-event reporting threshold: 1%

Serious adverse events should be reported within 24 hours of learning of the occurrence. Non-serious adverse events and non-serious adverse device effects will be reported to Lumicell on the adverse events Case Report Forms during the study.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Device Intervention: LUM Imaging System Used During Surgery The LUM Imaging Device was used to examine inside the lumpectomy cavity to determine if the dye indicated any areas that might contain residual tumor. If the imaging tested positive for the cancer cells remaining in the lumpectomy cavity, the surgeon would remove an additional piece of tissue. This process was continued until a negative reading from the device was obtained or a maximum of 2 shaves of additional tissue had been removed. Patients in this arm received the study drug, LUM015. Study Device Arm: LUM015 was administered 2 to 6 hours prior to surgery. The LUM Imaging device was used to assist in the removal of additional tumor tissue.	3 / 357	334 / 357	0 / 357
Standard of Care Arm The LUM Imaging Device was not used to guide additional tissue removal. Patients in this arm will receive the study drug, LUM015.	0 / 35	32 / 35	0 / 35
Withdrawn Before Randomization All the patients injected with LUM015 but withdrawn before randomization.	2 / 14	13 / 14	0 / 14

Group identifiers: EG000: Device Intervention: LUM Imaging System Used During Surgery · EG001: Standard of Care Arm · EG002: Withdrawn Before Randomization

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
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
1
num At Risk
357
num Events
1
group Id
EG001
num Affected
0
num At Risk
35
num Events
0
group Id
EG002
num Affected
0
num At Risk
14
num Events
0
term
Acute respiratory failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
1
num At Risk
357
num Events
1
group Id
EG001
num Affected
0
num At Risk
35
num Events
0
group Id
EG002
num Affected
0
num At Risk
14
num Events
0
term
Somnolence
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
1
num At Risk
357
num Events
1
group Id
EG001
num Affected
0
num At Risk
35
num Events
0
group Id
EG002
num Affected
0
num At Risk
14
num Events
0
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
1
num At Risk
357
num Events
1
group Id
EG001
num Affected
0
num At Risk
35
num Events
0
group Id
EG002
num Affected
0
num At Risk
14
num Events
0
term
Breast cellulitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
1
num At Risk
357
num Events
1
group Id
EG001
num Affected
0
num At Risk
35
num Events
0
group Id
EG002
num Affected
0
num At Risk
14
num Events
0
term
Vascular pseudoaneurysm
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
0
num At Risk
357
num Events
0
group Id
EG001
num Affected
0
num At Risk
35
num Events
0
group Id
EG002
num Affected
1
num At Risk
14
num Events
1
term
Hypersensitivity
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
0
num At Risk
357
num Events
0
group Id
EG001
num Affected
0
num At Risk
35
num Events
0
group Id
EG002
num Affected
1
num At Risk
14
num Events
1
term
Anaphylactic reaction

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
Renal and urinary disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
325
num At Risk
357
num Events
325
group Id
EG001
num Affected
30
num At Risk
35
num Events
30
group Id
EG002
num Affected
13
num At Risk
14
num Events
13
term
Chromaturia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Reproductive system and breast disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
20
num At Risk
357
num Events
22
group Id
EG001
num Affected
1
num At Risk
35
num Events
1
group Id
EG002
num Affected
1
num At Risk
14
num Events
2
term
Breast pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
11
num At Risk
357
num Events
11
group Id
EG001
num Affected
1
num At Risk
35
num Events
1
group Id
EG002
num Affected
2
num At Risk
14
num Events
2
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
10
num At Risk
357
num Events
10
group Id
EG001
num Affected
0
num At Risk
35
num Events
0
group Id
EG002
num Affected
0
num At Risk
14
num Events
0
term
Procedural pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
6
num At Risk
357
num Events
6
group Id
EG001
num Affected
0
num At Risk
35
num Events
0
group Id
EG002
num Affected
0
num At Risk
14
num Events
0
term
Erythema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
6
num At Risk
357
num Events
6
group Id
EG001
num Affected
0
num At Risk
35
num Events
0
group Id
EG002
num Affected
0
num At Risk
14
num Events
0
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
5
num At Risk
357
num Events
5
group Id
EG001
num Affected
0
num At Risk
35
num Events
0
group Id
EG002
num Affected
0
num At Risk
14
num Events
0
term
Contusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
5
num At Risk
357
num Events
5
group Id
EG001
num Affected
0
num At Risk
35
num Events
0
group Id
EG002
num Affected
0
num At Risk
14
num Events
0
term
Ecchymosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
4
num At Risk
357
num Events
5
group Id
EG001
num Affected
1
num At Risk
35
num Events
1
group Id
EG002
num Affected
0
num At Risk
14
num Events
0
term
Rash
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
4
num At Risk
357
num Events
4
group Id
EG001
num Affected
0
num At Risk
35
num Events
0
group Id
EG002
num Affected
0
num At Risk
14
num Events
0
term
Haematoma
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
4
num At Risk
357
num Events
4
group Id
EG001
num Affected
0
num At Risk
35
num Events
0
group Id
EG002
num Affected
0
num At Risk
14
num Events
0
term
Pruritus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
3
num At Risk
357
num Events
3
group Id
EG001
num Affected
0
num At Risk
35
num Events
0
group Id
EG002
num Affected
1
num At Risk
14
num Events
1
term
Blood creatinine decreased

Complete source fields

description

event Groups

deaths Num Affected
0
deaths Num At Risk
357
description
The LUM Imaging Device was used to examine inside the lumpectomy cavity to determine if the dye indicated any areas that might contain residual tumor. If the imaging tested positive for the cancer cells remaining in the lumpectomy cavity, the surgeon would remove an additional piece of tissue. This process was continued until a negative reading from the device was obtained or a maximum of 2 shaves of additional tissue had been removed. Patients in this arm received the study drug, LUM015. Study Device Arm: LUM015 was administered 2 to 6 hours prior to surgery. The LUM Imaging device was used to assist in the removal of additional tumor tissue.
id
EG000
other Num Affected
334
other Num At Risk
357
serious Num Affected
3
serious Num At Risk
357
title
Device Intervention: LUM Imaging System Used During Surgery
deaths Num Affected
0
deaths Num At Risk
35
description
The LUM Imaging Device was not used to guide additional tissue removal. Patients in this arm will receive the study drug, LUM015.
id
EG001
other Num Affected
32
other Num At Risk
35
serious Num Affected
0
serious Num At Risk
35
title
Standard of Care Arm
deaths Num Affected
0
deaths Num At Risk
14
description
All the patients injected with LUM015 but withdrawn before randomization.
id
EG002
other Num Affected
13
other Num At Risk
14
serious Num Affected
2
serious Num At Risk
14
title
Withdrawn Before Randomization

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
325
num At Risk
357
num Events
325
group Id
EG001
num Affected
30
num At Risk
35
num Events
30
group Id
EG002
num Affected
13
num At Risk
14
num Events
13
term
Chromaturia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Reproductive system and breast disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
20
num At Risk
357
num Events
22
group Id
EG001
num Affected
1
num At Risk
35
num Events
1
group Id
EG002
num Affected
1
num At Risk
14
num Events
2
term
Breast pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
11
num At Risk
357
num Events
11
group Id
EG001
num Affected
1
num At Risk
35
num Events
1
group Id
EG002
num Affected
2
num At Risk
14
num Events
2
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
10
num At Risk
357
num Events
10
group Id
EG001
num Affected
0
num At Risk
35
num Events
0
group Id
EG002
num Affected
0
num At Risk
14
num Events
0
term
Procedural pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
6
num At Risk
357
num Events
6
group Id
EG001
num Affected
0
num At Risk
35
num Events
0
group Id
EG002
num Affected
0
num At Risk
14
num Events
0
term
Erythema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
6
num At Risk
357
num Events
6
group Id
EG001
num Affected
0
num At Risk
35
num Events
0
group Id
EG002
num Affected
0
num At Risk
14
num Events
0
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
5
num At Risk
357
num Events
5
group Id
EG001
num Affected
0
num At Risk
35
num Events
0
group Id
EG002
num Affected
0
num At Risk
14
num Events
0
term
Contusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
5
num At Risk
357
num Events
5
group Id
EG001
num Affected
0
num At Risk
35
num Events
0
group Id
EG002
num Affected
0
num At Risk
14
num Events
0
term
Ecchymosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
4
num At Risk
357
num Events
5
group Id
EG001
num Affected
1
num At Risk
35
num Events
1
group Id
EG002
num Affected
0
num At Risk
14
num Events
0
term
Rash
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
4
num At Risk
357
num Events
4
group Id
EG001
num Affected
0
num At Risk
35
num Events
0
group Id
EG002
num Affected
0
num At Risk
14
num Events
0
term
Haematoma
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
4
num At Risk
357
num Events
4
group Id
EG001
num Affected
0
num At Risk
35
num Events
0
group Id
EG002
num Affected
0
num At Risk
14
num Events
0
term
Pruritus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
3
num At Risk
357
num Events
3
group Id
EG001
num Affected
0
num At Risk
35
num Events
0
group Id
EG002
num Affected
1
num At Risk
14
num Events
1
term
Blood creatinine decreased

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
1
num At Risk
357
num Events
1
group Id
EG001
num Affected
0
num At Risk
35
num Events
0
group Id
EG002
num Affected
0
num At Risk
14
num Events
0
term
Acute respiratory failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
1
num At Risk
357
num Events
1
group Id
EG001
num Affected
0
num At Risk
35
num Events
0
group Id
EG002
num Affected
0
num At Risk
14
num Events
0
term
Somnolence
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
1
num At Risk
357
num Events
1
group Id
EG001
num Affected
0
num At Risk
35
num Events
0
group Id
EG002
num Affected
0
num At Risk
14
num Events
0
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
1
num At Risk
357
num Events
1
group Id
EG001
num Affected
0
num At Risk
35
num Events
0
group Id
EG002
num Affected
0
num At Risk
14
num Events
0
term
Breast cellulitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
1
num At Risk
357
num Events
1
group Id
EG001
num Affected
0
num At Risk
35
num Events
0
group Id
EG002
num Affected
0
num At Risk
14
num Events
0
term
Vascular pseudoaneurysm
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
0
num At Risk
357
num Events
0
group Id
EG001
num Affected
0
num At Risk
35
num Events
0
group Id
EG002
num Affected
1
num At Risk
14
num Events
1
term
Hypersensitivity
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
0
num At Risk
357
num Events
0
group Id
EG001
num Affected
0
num At Risk
35
num Events
0
group Id
EG002
num Affected
1
num At Risk
14
num Events
1
term
Anaphylactic reaction

time Frame

All adverse events and adverse device effects, both serious and non-serious, and deaths that are encountered from initiation of study intervention, throughout the study, and within the first post-operative follow-up visit should be followed to their resolution, or until the principal investigator assesses them as stable, or the principal investigator determines the event to be irreversible, or the subject is lost to follow-up. Adverse events were assessed up to 30 days after enrollment.

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