NCT03180684 · ADVERSE EVENTS

Adverse events

Evaluation of VGX-3100 and Electroporation Alone or in Combination With Imiquimod for the Treatment of HPV-16 and/or HPV-18 Related Vulvar HSIL (Also Referred as: VIN 2 or VIN 3) · Source last updated 2023-08-25

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: From the first injection up to Week 100
Other-event reporting threshold: 5%

Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
VGX-3100 + EP Participants with histologically confirmed vulvar HSIL associated with HPV-16 and/or 18, received four doses of 6 mg VGX-3100 as an IM injection on Day 0, Week 4, Week 12, and Week 24 followed by EP using the CELLECTRA™ 2000 device. Participants with vulvar HSIL who had a reduction in lesion size or no increase in lesion size at Week 48, received a fifth dose of VGX-3100 at Week 52.	3 / 25	23 / 25	0 / 25
VGX-3100 + EP + Imiquimod Participants with histologically confirmed vulvar HSIL associated with HPV-16 and/or 18, received four doses of 6 mg VGX-3100 as an IM injection on Day 0, Week 4, Week 12, and Week 24 followed by EP using the CELLECTRA™ 2000 device. Participants with vulvar HSIL who had a reduction in lesion size or no increase in lesion size at Week 48, received a fifth dose of VGX-3100 at Week 52.	0 / 8	8 / 8	0 / 8

Group identifiers: EG000: VGX-3100 + EP · EG001: VGX-3100 + EP + Imiquimod

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
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
25
group Id
EG001
num Affected
0
num At Risk
8
term
Back pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
25
group Id
EG001
num Affected
0
num At Risk
8
term
Ulcer
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
25
group Id
EG001
num Affected
0
num At Risk
8
term
Cellulitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
25
group Id
EG001
num Affected
0
num At Risk
8
term
Pulmonary mass

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
MedDRA 23.0
stats
group Id
EG000
num Affected
2
num At Risk
25
group Id
EG001
num Affected
0
num At Risk
8
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
25
group Id
EG001
num Affected
1
num At Risk
8
term
Ear pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
25
group Id
EG001
num Affected
1
num At Risk
8
term
Vision blurred
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
10
num At Risk
25
group Id
EG001
num Affected
3
num At Risk
8
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
3
num At Risk
25
group Id
EG001
num Affected
1
num At Risk
8
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
25
group Id
EG001
num Affected
1
num At Risk
8
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
25
group Id
EG001
num Affected
1
num At Risk
8
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
18
num At Risk
25
group Id
EG001
num Affected
6
num At Risk
8
term
Injection site pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
14
num At Risk
25
group Id
EG001
num Affected
4
num At Risk
8
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
9
num At Risk
25
group Id
EG001
num Affected
3
num At Risk
8
term
Injection site swelling
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
8
num At Risk
25
group Id
EG001
num Affected
3
num At Risk
8
term
Injection site erythema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
10
num At Risk
25
group Id
EG001
num Affected
0
num At Risk
8
term
Injection site bruising

Complete source fields

description

Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).

event Groups

deaths Num Affected
0
deaths Num At Risk
25
description
Participants with histologically confirmed vulvar HSIL associated with HPV-16 and/or 18, received four doses of 6 mg VGX-3100 as an IM injection on Day 0, Week 4, Week 12, and Week 24 followed by EP using the CELLECTRA™ 2000 device. Participants with vulvar HSIL who had a reduction in lesion size or no increase in lesion size at Week 48, received a fifth dose of VGX-3100 at Week 52.
id
EG000
other Num Affected
23
other Num At Risk
25
serious Num Affected
3
serious Num At Risk
25
title
VGX-3100 + EP
deaths Num Affected
0
deaths Num At Risk
8
description
Participants with histologically confirmed vulvar HSIL associated with HPV-16 and/or 18, received four doses of 6 mg VGX-3100 as an IM injection on Day 0, Week 4, Week 12, and Week 24 followed by EP using the CELLECTRA™ 2000 device. Participants with vulvar HSIL who had a reduction in lesion size or no increase in lesion size at Week 48, received a fifth dose of VGX-3100 at Week 52.
id
EG001
other Num Affected
8
other Num At Risk
8
serious Num Affected
0
serious Num At Risk
8
title
VGX-3100 + EP + Imiquimod

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
2
num At Risk
25
group Id
EG001
num Affected
0
num At Risk
8
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
25
group Id
EG001
num Affected
1
num At Risk
8
term
Ear pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
25
group Id
EG001
num Affected
1
num At Risk
8
term
Vision blurred
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
10
num At Risk
25
group Id
EG001
num Affected
3
num At Risk
8
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
3
num At Risk
25
group Id
EG001
num Affected
1
num At Risk
8
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
25
group Id
EG001
num Affected
1
num At Risk
8
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
25
group Id
EG001
num Affected
1
num At Risk
8
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
18
num At Risk
25
group Id
EG001
num Affected
6
num At Risk
8
term
Injection site pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
14
num At Risk
25
group Id
EG001
num Affected
4
num At Risk
8
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
9
num At Risk
25
group Id
EG001
num Affected
3
num At Risk
8
term
Injection site swelling
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
8
num At Risk
25
group Id
EG001
num Affected
3
num At Risk
8
term
Injection site erythema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
10
num At Risk
25
group Id
EG001
num Affected
0
num At Risk
8
term
Injection site bruising

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
25
group Id
EG001
num Affected
0
num At Risk
8
term
Back pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
25
group Id
EG001
num Affected
0
num At Risk
8
term
Ulcer
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
25
group Id
EG001
num Affected
0
num At Risk
8
term
Cellulitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
25
group Id
EG001
num Affected
0
num At Risk
8
term
Pulmonary mass

time Frame

From the first injection up to Week 100

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Preserved source evidence · Not medical advice