Adverse Events Possibly, Probably or Definitely Related to Study Treatment
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.
Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to 24 weeks
What was measured
Number of participants with adverse events (by Grade) that were possibly, probably or definitely related to the combined study immunotherapy regimen (αDC1 vaccines + CKM) per CTCAE v 4.0 (Common Terminology Criteria for Adverse Events).
Analysis population: Patients treated with at least 1 course of α DC1 vaccine + 1 cycle of chemokine modulatory regimen who were evaluable for for completing surgery.
Groups in this outcome
α DC1 Vaccine + 1 Cycle of Chemokine Modulatory Regimen
α DC1 Vaccine
and
Chemokine Modulatory Regimen:
Celecoxib: Administered at 200 mg, once a day orally (T-TH) Rintatolimod: Intravenous infusion of 200 mg (Wed \& and Fri, only) Interferon Alfa-2b: Intravenous infusion - 5 MU/m\^2 or 20 MU/m\^2 (T-Fri)
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
Group
Source count
α DC1 Vaccine + 1 Cycle of Chemokine Modulatory Regimen
38
Reported measurements
Anemia : Grade 1-2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
α DC1 Vaccine + 1 Cycle of Chemokine Modulatory Regimen
3
Not reported
Not reported
Not reported
Not reported
Anemia : Grade 3-4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
α DC1 Vaccine + 1 Cycle of Chemokine Modulatory Regimen
1
Not reported
Not reported
Not reported
Not reported
Blurred vision : Grade 1-2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
α DC1 Vaccine + 1 Cycle of Chemokine Modulatory Regimen
1
Not reported
Not reported
Not reported
Not reported
Blurred vision : Grade 3-4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
α DC1 Vaccine + 1 Cycle of Chemokine Modulatory Regimen
0
Not reported
Not reported
Not reported
Not reported
Bruising : Grade 1-2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
α DC1 Vaccine + 1 Cycle of Chemokine Modulatory Regimen
1
Not reported
Not reported
Not reported
Not reported
Bruising : Grade 3-4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
α DC1 Vaccine + 1 Cycle of Chemokine Modulatory Regimen
0
Not reported
Not reported
Not reported
Not reported
Chills : Grade 1-2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
α DC1 Vaccine + 1 Cycle of Chemokine Modulatory Regimen
34
Not reported
Not reported
Not reported
Not reported
Chills : Grade 3-4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
α DC1 Vaccine + 1 Cycle of Chemokine Modulatory Regimen
0
Not reported
Not reported
Not reported
Not reported
Diarrhea : Grade 1-2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
α DC1 Vaccine + 1 Cycle of Chemokine Modulatory Regimen
7
Not reported
Not reported
Not reported
Not reported
Diarrhea : Grade 3-4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
α DC1 Vaccine + 1 Cycle of Chemokine Modulatory Regimen
1
Not reported
Not reported
Not reported
Not reported
Dizziness : Grade 1-2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
α DC1 Vaccine + 1 Cycle of Chemokine Modulatory Regimen
1
Not reported
Not reported
Not reported
Not reported
Dizziness : Grade 3-4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
α DC1 Vaccine + 1 Cycle of Chemokine Modulatory Regimen
0
Not reported
Not reported
Not reported
Not reported
Eye disorders - Other, specify : Grade 1-2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
α DC1 Vaccine + 1 Cycle of Chemokine Modulatory Regimen
0
Not reported
Not reported
Not reported
Not reported
Eye disorders - Other, specify : Grade 3-4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
α DC1 Vaccine + 1 Cycle of Chemokine Modulatory Regimen
1
Not reported
Not reported
Not reported
Not reported
Fatigue : Grade 1-2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
α DC1 Vaccine + 1 Cycle of Chemokine Modulatory Regimen
15
Not reported
Not reported
Not reported
Not reported
Fatigue : Grade 3-4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
α DC1 Vaccine + 1 Cycle of Chemokine Modulatory Regimen
0
Not reported
Not reported
Not reported
Not reported
Fever : Grade 1-2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
α DC1 Vaccine + 1 Cycle of Chemokine Modulatory Regimen
7
Not reported
Not reported
Not reported
Not reported
Fever : Grade 3-4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
α DC1 Vaccine + 1 Cycle of Chemokine Modulatory Regimen
0
Not reported
Not reported
Not reported
Not reported
Flu like symptoms : Grade 1-2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
α DC1 Vaccine + 1 Cycle of Chemokine Modulatory Regimen
5
Not reported
Not reported
Not reported
Not reported
Flu like symptoms : Grade 3-4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
α DC1 Vaccine + 1 Cycle of Chemokine Modulatory Regimen
0
Not reported
Not reported
Not reported
Not reported
Flushing : Grade 1-2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
α DC1 Vaccine + 1 Cycle of Chemokine Modulatory Regimen
3
Not reported
Not reported
Not reported
Not reported
Flushing : Grade 3-4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
α DC1 Vaccine + 1 Cycle of Chemokine Modulatory Regimen
0
Not reported
Not reported
Not reported
Not reported
General disorders and administration : Grade 1-2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
α DC1 Vaccine + 1 Cycle of Chemokine Modulatory Regimen
7
Not reported
Not reported
Not reported
Not reported
General disorders and administration: Grade 3-4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
α DC1 Vaccine + 1 Cycle of Chemokine Modulatory Regimen
0
Not reported
Not reported
Not reported
Not reported
Headache : Grade 1-2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
α DC1 Vaccine + 1 Cycle of Chemokine Modulatory Regimen
10
Not reported
Not reported
Not reported
Not reported
Headache : Grade 3-4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
α DC1 Vaccine + 1 Cycle of Chemokine Modulatory Regimen
0
Not reported
Not reported
Not reported
Not reported
Heart failure : Grade 1-2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
α DC1 Vaccine + 1 Cycle of Chemokine Modulatory Regimen
0
Not reported
Not reported
Not reported
Not reported
Heart failure : Grade 3-4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
α DC1 Vaccine + 1 Cycle of Chemokine Modulatory Regimen
1
Not reported
Not reported
Not reported
Not reported
Hypotension : Grade 1-2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
α DC1 Vaccine + 1 Cycle of Chemokine Modulatory Regimen
1
Not reported
Not reported
Not reported
Not reported
Hypotension : Grade 3-4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
α DC1 Vaccine + 1 Cycle of Chemokine Modulatory Regimen
0
Not reported
Not reported
Not reported
Not reported
Hypothyroidism : Grade 1-2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
α DC1 Vaccine + 1 Cycle of Chemokine Modulatory Regimen
2
Not reported
Not reported
Not reported
Not reported
Hypothyroidism : Grade 3-4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
α DC1 Vaccine + 1 Cycle of Chemokine Modulatory Regimen
0
Not reported
Not reported
Not reported
Not reported
Lymphocyte count decreased : Grade 1-2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
α DC1 Vaccine + 1 Cycle of Chemokine Modulatory Regimen
4
Not reported
Not reported
Not reported
Not reported
Lymphocyte count decreased : Grade 3-4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
α DC1 Vaccine + 1 Cycle of Chemokine Modulatory Regimen
1
Not reported
Not reported
Not reported
Not reported
Myalgia : Grade 1-2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
α DC1 Vaccine + 1 Cycle of Chemokine Modulatory Regimen
3
Not reported
Not reported
Not reported
Not reported
Myalgia : Grade 3-4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
α DC1 Vaccine + 1 Cycle of Chemokine Modulatory Regimen
0
Not reported
Not reported
Not reported
Not reported
Nausea : Grade 1-2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
α DC1 Vaccine + 1 Cycle of Chemokine Modulatory Regimen
13
Not reported
Not reported
Not reported
Not reported
Nausea : Grade 3-4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
α DC1 Vaccine + 1 Cycle of Chemokine Modulatory Regimen
0
Not reported
Not reported
Not reported
Not reported
Neutrophil count decreased : Grade 1-2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
α DC1 Vaccine + 1 Cycle of Chemokine Modulatory Regimen
3
Not reported
Not reported
Not reported
Not reported
Neutrophil count decreased : Grade 3-4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
α DC1 Vaccine + 1 Cycle of Chemokine Modulatory Regimen
0
Not reported
Not reported
Not reported
Not reported
Pain : Grade 1-2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
α DC1 Vaccine + 1 Cycle of Chemokine Modulatory Regimen
6
Not reported
Not reported
Not reported
Not reported
Pain : Grade 3-4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
α DC1 Vaccine + 1 Cycle of Chemokine Modulatory Regimen
0
Not reported
Not reported
Not reported
Not reported
Platelet count decreased : Grade 1-2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
α DC1 Vaccine + 1 Cycle of Chemokine Modulatory Regimen
1
Not reported
Not reported
Not reported
Not reported
Platelet count decreased : Grade 3-4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
α DC1 Vaccine + 1 Cycle of Chemokine Modulatory Regimen
0
Not reported
Not reported
Not reported
Not reported
Pleural effusion : Grade 1-2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
α DC1 Vaccine + 1 Cycle of Chemokine Modulatory Regimen
1
Not reported
Not reported
Not reported
Not reported
Pleural effusion : Grade 3-4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
α DC1 Vaccine + 1 Cycle of Chemokine Modulatory Regimen
0
Not reported
Not reported
Not reported
Not reported
Serum amylase increased : Grade 1-2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
α DC1 Vaccine + 1 Cycle of Chemokine Modulatory Regimen
1
Not reported
Not reported
Not reported
Not reported
Serum amylase increased : Grade 3-4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
α DC1 Vaccine + 1 Cycle of Chemokine Modulatory Regimen
0
Not reported
Not reported
Not reported
Not reported
Sinus bradycardia : Grade 1-2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
α DC1 Vaccine + 1 Cycle of Chemokine Modulatory Regimen
2
Not reported
Not reported
Not reported
Not reported
Sinus bradycardia : Grade 3-4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
α DC1 Vaccine + 1 Cycle of Chemokine Modulatory Regimen
0
Not reported
Not reported
Not reported
Not reported
Vomiting : Grade 1-2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
α DC1 Vaccine + 1 Cycle of Chemokine Modulatory Regimen
7
Not reported
Not reported
Not reported
Not reported
Vomiting : Grade 3-4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
α DC1 Vaccine + 1 Cycle of Chemokine Modulatory Regimen
0
Not reported
Not reported
Not reported
Not reported
Weight gain : Grade 1-2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
α DC1 Vaccine + 1 Cycle of Chemokine Modulatory Regimen
1
Not reported
Not reported
Not reported
Not reported
Weight gain : Grade 3-4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
α DC1 Vaccine + 1 Cycle of Chemokine Modulatory Regimen
0
Not reported
Not reported
Not reported
Not reported
White blood cell decreased : Grade 1-2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
α DC1 Vaccine + 1 Cycle of Chemokine Modulatory Regimen
3
Not reported
Not reported
Not reported
Not reported
White blood cell decreased : Grade 3-4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
α DC1 Vaccine + 1 Cycle of Chemokine Modulatory Regimen
0
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
3
title
Anemia : Grade 1-2
categories
measurements
group Id
OG000
value
1
title
Anemia : Grade 3-4
categories
measurements
group Id
OG000
value
1
title
Blurred vision : Grade 1-2
categories
measurements
group Id
OG000
value
0
title
Blurred vision : Grade 3-4
categories
measurements
group Id
OG000
value
1
title
Bruising : Grade 1-2
categories
measurements
group Id
OG000
value
0
title
Bruising : Grade 3-4
categories
measurements
group Id
OG000
value
34
title
Chills : Grade 1-2
categories
measurements
group Id
OG000
value
0
title
Chills : Grade 3-4
categories
measurements
group Id
OG000
value
7
title
Diarrhea : Grade 1-2
categories
measurements
group Id
OG000
value
1
title
Diarrhea : Grade 3-4
categories
measurements
group Id
OG000
value
1
title
Dizziness : Grade 1-2
categories
measurements
group Id
OG000
value
0
title
Dizziness : Grade 3-4
denoms
counts
group Id
OG000
value
38
units
Participants
description
Number of participants with adverse events (by Grade) that were possibly, probably or definitely related to the combined study immunotherapy regimen (αDC1 vaccines + CKM) per CTCAE v 4.0 (Common Terminology Criteria for Adverse Events).
groups
description
α DC1 Vaccine
and
Chemokine Modulatory Regimen:
Celecoxib: Administered at 200 mg, once a day orally (T-TH) Rintatolimod: Intravenous infusion of 200 mg (Wed \& and Fri, only) Interferon Alfa-2b: Intravenous infusion - 5 MU/m\^2 or 20 MU/m\^2 (T-Fri)
id
OG000
title
α DC1 Vaccine + 1 Cycle of Chemokine Modulatory Regimen
param Type
COUNT_OF_PARTICIPANTS
population Description
Patients treated with at least 1 course of α DC1 vaccine + 1 cycle of chemokine modulatory regimen who were evaluable for for completing surgery.
reporting Status
POSTED
time Frame
Up to 24 weeks
title
Adverse Events Possibly, Probably or Definitely Related to Study Treatment
Triangle