NCT00623831 · ADVERSE EVENTS

Adverse events

A Phase 1 Study of Mixed Bacteria Vaccine (MBV) in Patients With Tumors Expressing NY-ESO-1 Antigen · Source last updated 2022-10-25

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 AEs occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 3 months for each subject.
Other-event reporting threshold: 0%

AE documentation included onset/resolution dates, severity using NCI CTCAE (v3.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Cohort 1 Subjects received MBV twice weekly by subcutaneous injection at a starting dose of 250 EU (dose level 1), with intrasubject dose escalations for each subsequent administration in the absence of a DLT until the desired pyrogenic effect was observed.	1 / 13	13 / 13	Not reported / Not reported
Cohort 2 Subjects received MBV twice weekly by intralesional (preferred) or subcutaneous (if intralesional not possible) injection at the fixed dose (60,800 EU \[dose level 6\]) that was determined to be the pyrogenic dose level in Cohort 1.	1 / 4	4 / 4	Not reported / Not reported

Group identifiers: EG000: Cohort 1 · EG001: Cohort 2

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
notes
Grade 5; not related to study drug
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
Verbatim event term
stats
group Id
EG000
num Affected
1
num At Risk
13
group Id
EG001
num Affected
0
num At Risk
4
term
Rapid disease progression
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Grade 3; not related to study drug
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
Verbatim event term
stats
group Id
EG000
num Affected
0
num At Risk
13
group Id
EG001
num Affected
1
num At Risk
4
term
Increased pleural effusion

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
General disorders
source Vocabulary
Verbatim event term
stats
group Id
EG000
num Affected
4
num At Risk
13
group Id
EG001
num Affected
2
num At Risk
4
term
Pain at injection site
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
Verbatim event term
stats
group Id
EG000
num Affected
3
num At Risk
13
group Id
EG001
num Affected
2
num At Risk
4
term
CRP elevation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
Verbatim event term
stats
group Id
EG000
num Affected
4
num At Risk
13
group Id
EG001
num Affected
0
num At Risk
4
term
Edema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
Verbatim event term
stats
group Id
EG000
num Affected
2
num At Risk
13
group Id
EG001
num Affected
2
num At Risk
4
term
Weakness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
Verbatim event term
stats
group Id
EG000
num Affected
1
num At Risk
13
group Id
EG001
num Affected
2
num At Risk
4
term
Chills
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
Verbatim event term
stats
group Id
EG000
num Affected
2
num At Risk
13
group Id
EG001
num Affected
1
num At Risk
4
term
Fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
Verbatim event term
stats
group Id
EG000
num Affected
2
num At Risk
13
group Id
EG001
num Affected
1
num At Risk
4
term
Hypertension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
Verbatim event term
stats
group Id
EG000
num Affected
3
num At Risk
13
group Id
EG001
num Affected
0
num At Risk
4
term
Hypotension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
Verbatim event term
stats
group Id
EG000
num Affected
2
num At Risk
13
group Id
EG001
num Affected
1
num At Risk
4
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
Verbatim event term
stats
group Id
EG000
num Affected
2
num At Risk
13
group Id
EG001
num Affected
1
num At Risk
4
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
Verbatim event term
stats
group Id
EG000
num Affected
2
num At Risk
13
group Id
EG001
num Affected
0
num At Risk
4
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
Verbatim event term
stats
group Id
EG000
num Affected
0
num At Risk
13
group Id
EG001
num Affected
2
num At Risk
4
term
Cough

Complete source fields

description

event Groups

description
Subjects received MBV twice weekly by subcutaneous injection at a starting dose of 250 EU (dose level 1), with intrasubject dose escalations for each subsequent administration in the absence of a DLT until the desired pyrogenic effect was observed.
id
EG000
other Num Affected
13
other Num At Risk
13
serious Num Affected
1
serious Num At Risk
13
title
Cohort 1
description
Subjects received MBV twice weekly by intralesional (preferred) or subcutaneous (if intralesional not possible) injection at the fixed dose (60,800 EU \[dose level 6\]) that was determined to be the pyrogenic dose level in Cohort 1.
id
EG001
other Num Affected
4
other Num At Risk
4
serious Num Affected
1
serious Num At Risk
4
title
Cohort 2

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
Verbatim event term
stats
group Id
EG000
num Affected
4
num At Risk
13
group Id
EG001
num Affected
2
num At Risk
4
term
Pain at injection site
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
Verbatim event term
stats
group Id
EG000
num Affected
3
num At Risk
13
group Id
EG001
num Affected
2
num At Risk
4
term
CRP elevation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
Verbatim event term
stats
group Id
EG000
num Affected
4
num At Risk
13
group Id
EG001
num Affected
0
num At Risk
4
term
Edema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
Verbatim event term
stats
group Id
EG000
num Affected
2
num At Risk
13
group Id
EG001
num Affected
2
num At Risk
4
term
Weakness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
Verbatim event term
stats
group Id
EG000
num Affected
1
num At Risk
13
group Id
EG001
num Affected
2
num At Risk
4
term
Chills
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
Verbatim event term
stats
group Id
EG000
num Affected
2
num At Risk
13
group Id
EG001
num Affected
1
num At Risk
4
term
Fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
Verbatim event term
stats
group Id
EG000
num Affected
2
num At Risk
13
group Id
EG001
num Affected
1
num At Risk
4
term
Hypertension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
Verbatim event term
stats
group Id
EG000
num Affected
3
num At Risk
13
group Id
EG001
num Affected
0
num At Risk
4
term
Hypotension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
Verbatim event term
stats
group Id
EG000
num Affected
2
num At Risk
13
group Id
EG001
num Affected
1
num At Risk
4
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
Verbatim event term
stats
group Id
EG000
num Affected
2
num At Risk
13
group Id
EG001
num Affected
1
num At Risk
4
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
Verbatim event term
stats
group Id
EG000
num Affected
2
num At Risk
13
group Id
EG001
num Affected
0
num At Risk
4
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
Verbatim event term
stats
group Id
EG000
num Affected
0
num At Risk
13
group Id
EG001
num Affected
2
num At Risk
4
term
Cough

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
notes
Grade 5; not related to study drug
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
Verbatim event term
stats
group Id
EG000
num Affected
1
num At Risk
13
group Id
EG001
num Affected
0
num At Risk
4
term
Rapid disease progression
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Grade 3; not related to study drug
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
Verbatim event term
stats
group Id
EG000
num Affected
0
num At Risk
13
group Id
EG001
num Affected
1
num At Risk
4
term
Increased pleural effusion

time Frame

All AEs occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 3 months for each subject.

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