NCT02151448 · ADVERSE EVENTS

Adverse events

αDC1 Vaccine + Chemokine Modulatory Regimen (CKM) as Adjuvant Treatment of Peritoneal Surface Malignancies · Source last updated 2020-07-20

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: 3 years, 6 months
Other-event reporting threshold: 5%

Adverse events data collected at screening, during clinical visit assessments and at follow-up and off treatment visits. Two Serious Adverse Events were Attributed to Study Treatment (2 events in 2 patients; excludes events from other causes): CARDIAC DISORDERS (Heart failure) EYE DISORDERS (Other)

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Vaccine + Chemokine Modulatory Regimen Week 1 (at recovery from surgery; ≥ 6 weeks post-surgery)-Priming Vaccine dose; no chemokine modulation; 1 day: αDC1 vaccine; Oral celecoxib, 200 mg, before \& after treatment on day of vaccination; Weeks 2-3 -Rest; Week 4 (target) - Booster C1; Mon: αDC1 vaccine;Tues - Fri: Systemic Chemokine Modulation Regimen. Oral celecoxib, 200 mg, BID on vaccination days \& CKM. Celecoxib will be dced after CKM on Fri. Rintatolimod only administered on Wed \& Fri.; Week 5-7 -Rest; Week 8 (target) -Booster C2; Monday: αDC1 vaccine. Oral celecoxib, 200 mg, BID on days of vaccination and CKM. Tues - Fri:Systemic Chemokine Modulation Regimen. Rintatolimod only administered on Wed \& Fri. Celecoxib will be dced after CKM on Fri.; Week 9-11 -Rest; Week 12 (target) -Booster C3; Monday: αDC1 vaccine. Tues-Fri: Systemic Chemokine Modulation Regimen. Rintatolimod only administered on Wed \& Fri. Oral celecoxib, 200 mg, BID, given on days of vaccination and CKM. Celecoxib will be discontinued after CKM on Fri.	17 / 64	46 / 64	23 / 64

Group identifiers: EG000: Vaccine + Chemokine Modulatory Regimen

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
Attributed to Study Treatment
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
64
term
Heart failure
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Attributed to Study Treatment
organ System
Eye disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
64
term
Eye disorders - Other, specify
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Not Attributed to Study Treatment
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
64
term
Ileus
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Not Attributed to Study Treatment
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
64
term
Small intestinal obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Not Attributed to Study Treatment
organ System
Hepatobiliary disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
64
term
Hepatobiliary disorders - Other, specify
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Not Attributed to Study Treatment
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
64
term
Catheter related infection
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Not Attributed to Study Treatment
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
64
term
Infections and infestations - Other, specify
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Not Attributed to Study Treatment
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
64
term
Urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Not Attributed to Study Treatment
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
64
term
Wound infection
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Not Attributed to Study Treatment
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
64
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Not Attributed to Study Treatment
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
64
term
Blood bilirubin increased
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Not Attributed to Study Treatment
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
64
term
Lymphocyte count decreased

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
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
4
num At Risk
64
term
Sinus bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
4
num At Risk
64
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
4
num At Risk
64
term
Weight gain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
4
num At Risk
64
term
Hypokalemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
5
num At Risk
64
term
Flu like symptoms
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
5
num At Risk
64
term
Blood bilirubin increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
5
num At Risk
64
term
Creatinine increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
6
num At Risk
64
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
6
num At Risk
64
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
7
num At Risk
64
term
Lipase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
7
num At Risk
64
term
Hypertension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
8
num At Risk
64
term
General disorders and administration site conditions - Other, specify

Complete source fields

description

event Groups

deaths Num Affected
23
deaths Num At Risk
64
description
Week 1 (at recovery from surgery; ≥ 6 weeks post-surgery)-Priming Vaccine dose; no chemokine modulation; 1 day: αDC1 vaccine; Oral celecoxib, 200 mg, before \& after treatment on day of vaccination; Weeks 2-3 -Rest; Week 4 (target) - Booster C1; Mon: αDC1 vaccine;Tues - Fri: Systemic Chemokine Modulation Regimen. Oral celecoxib, 200 mg, BID on vaccination days \& CKM. Celecoxib will be dced after CKM on Fri. Rintatolimod only administered on Wed \& Fri.; Week 5-7 -Rest; Week 8 (target) -Booster C2; Monday: αDC1 vaccine. Oral celecoxib, 200 mg, BID on days of vaccination and CKM. Tues - Fri:Systemic Chemokine Modulation Regimen. Rintatolimod only administered on Wed \& Fri. Celecoxib will be dced after CKM on Fri.; Week 9-11 -Rest; Week 12 (target) -Booster C3; Monday: αDC1 vaccine. Tues-Fri: Systemic Chemokine Modulation Regimen. Rintatolimod only administered on Wed \& Fri. Oral celecoxib, 200 mg, BID, given on days of vaccination and CKM. Celecoxib will be discontinued after CKM on Fri.
id
EG000
other Num Affected
46
other Num At Risk
64
serious Num Affected
17
serious Num At Risk
64
title
Vaccine + Chemokine Modulatory Regimen

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
4
num At Risk
64
term
Sinus bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
4
num At Risk
64
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
4
num At Risk
64
term
Weight gain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
4
num At Risk
64
term
Hypokalemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
5
num At Risk
64
term
Flu like symptoms
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
5
num At Risk
64
term
Blood bilirubin increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
5
num At Risk
64
term
Creatinine increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
6
num At Risk
64
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
6
num At Risk
64
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
7
num At Risk
64
term
Lipase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
7
num At Risk
64
term
Hypertension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
8
num At Risk
64
term
General disorders and administration site conditions - Other, specify

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
notes
Attributed to Study Treatment
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
64
term
Heart failure
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Attributed to Study Treatment
organ System
Eye disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
64
term
Eye disorders - Other, specify
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Not Attributed to Study Treatment
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
64
term
Ileus
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Not Attributed to Study Treatment
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
64
term
Small intestinal obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Not Attributed to Study Treatment
organ System
Hepatobiliary disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
64
term
Hepatobiliary disorders - Other, specify
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Not Attributed to Study Treatment
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
64
term
Catheter related infection
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Not Attributed to Study Treatment
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
64
term
Infections and infestations - Other, specify
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Not Attributed to Study Treatment
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
64
term
Urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Not Attributed to Study Treatment
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
64
term
Wound infection
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Not Attributed to Study Treatment
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
64
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Not Attributed to Study Treatment
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
64
term
Blood bilirubin increased
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Not Attributed to Study Treatment
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
64
term
Lymphocyte count decreased

time Frame

3 years, 6 months

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Preserved source evidence · Not medical advice