NCT01047345 · ADVERSE EVENTS

Adverse events

A Study of V503, a 9-valent Human Papillomavirus (9vHPV) Vaccine in Females 12-26 Years of Age Who Have Previously Received GARDASIL™ (V503-006) · Source last updated 2018-11-27

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: Up to 5 days after any vaccination (Non-serious injection site AEs); up to 15 days after any vaccination (Non-serious systemic AEs) and up to 7 months (Serious AEs) - Base Study and Extension Study
Other-event reporting threshold: 5%

Population included all participants who received at least 1 vaccination and had available follow-up data. Only SAEs were collected systematically in the Extension Study. Although some unsolicited non-serious AEs were reported during the Extension Study, none exceeded the 5% cut-off.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
9vHPV Vaccine - Base Study Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.	3 / 608	566 / 608	Not reported / Not reported
Placebo - Base Study Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.	3 / 305	197 / 305	Not reported / Not reported
9vHPV Vaccine - Extension Study Participants who received placebo in Base Study and elected to have open-label 9vHPV vaccination in Extension Study.	2 / 99	0 / 99	Not reported / Not reported

Group identifiers: EG000: 9vHPV Vaccine - Base Study · EG001: Placebo - Base Study · EG002: 9vHPV Vaccine - Extension Study

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
Infections and infestations
source Vocabulary
MedDRA Version 14.0
stats
group Id
EG000
num Affected
1
num At Risk
608
num Events
1
group Id
EG001
num Affected
0
num At Risk
305
num Events
0
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
term
Appendicitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 14.0
stats
group Id
EG000
num Affected
1
num At Risk
608
num Events
1
group Id
EG001
num Affected
0
num At Risk
305
num Events
0
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
term
Tonsillitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA Version 14.0
stats
group Id
EG000
num Affected
0
num At Risk
608
num Events
0
group Id
EG001
num Affected
1
num At Risk
305
num Events
1
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
term
Lumbar vertebral fracture
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA Version 14.0
stats
group Id
EG000
num Affected
0
num At Risk
608
num Events
0
group Id
EG001
num Affected
1
num At Risk
305
num Events
1
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
term
Thoracic vertebral fracture
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA Version 14.0
stats
group Id
EG000
num Affected
0
num At Risk
608
num Events
0
group Id
EG001
num Affected
1
num At Risk
305
num Events
1
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
term
Migraine
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA Version 14.0
stats
group Id
EG000
num Affected
1
num At Risk
608
num Events
1
group Id
EG001
num Affected
0
num At Risk
305
num Events
0
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
term
Syncope
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Surgical and medical procedures
source Vocabulary
MedDRA Version 14.0
stats
group Id
EG000
num Affected
0
num At Risk
608
num Events
0
group Id
EG001
num Affected
1
num At Risk
305
num Events
1
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
term
Abortion induced
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 14.0
stats
group Id
EG000
num Affected
0
num At Risk
608
num Events
0
group Id
EG001
num Affected
0
num At Risk
305
num Events
0
group Id
EG002
num Affected
1
num At Risk
99
num Events
1
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 14.0
stats
group Id
EG000
num Affected
0
num At Risk
608
num Events
0
group Id
EG001
num Affected
0
num At Risk
305
num Events
0
group Id
EG002
num Affected
1
num At Risk
99
num Events
1
term
Diarrhoea

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
Gastrointestinal disorders
source Vocabulary
MedDRA Version 14.0
stats
group Id
EG000
num Affected
52
num At Risk
608
num Events
67
group Id
EG001
num Affected
12
num At Risk
305
num Events
13
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA Version 14.0
stats
group Id
EG000
num Affected
258
num At Risk
608
num Events
420
group Id
EG001
num Affected
26
num At Risk
305
num Events
33
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
term
Injection site erythema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA Version 14.0
stats
group Id
EG000
num Affected
549
num At Risk
608
num Events
1392
group Id
EG001
num Affected
117
num At Risk
305
num Events
182
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
term
Injection site pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA Version 14.0
stats
group Id
EG000
num Affected
48
num At Risk
608
num Events
68
group Id
EG001
num Affected
4
num At Risk
305
num Events
5
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
term
Injection site pruritus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA Version 14.0
stats
group Id
EG000
num Affected
298
num At Risk
608
num Events
558
group Id
EG001
num Affected
18
num At Risk
305
num Events
27
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
term
Injection site swelling
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA Version 14.0
stats
group Id
EG000
num Affected
42
num At Risk
608
num Events
50
group Id
EG001
num Affected
10
num At Risk
305
num Events
10
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 14.0
stats
group Id
EG000
num Affected
47
num At Risk
608
num Events
55
group Id
EG001
num Affected
19
num At Risk
305
num Events
20
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
term
Nasopharyngitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA Version 14.0
stats
group Id
EG000
num Affected
31
num At Risk
608
num Events
34
group Id
EG001
num Affected
6
num At Risk
305
num Events
8
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
term
Dizziness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA Version 14.0
stats
group Id
EG000
num Affected
190
num At Risk
608
num Events
318
group Id
EG001
num Affected
81
num At Risk
305
num Events
150
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
term
Headache
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA Version 14.0
stats
group Id
EG000
num Affected
40
num At Risk
608
num Events
46
group Id
EG001
num Affected
12
num At Risk
305
num Events
14
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
term
Oropharyngeal pain

Complete source fields

description

event Groups

description
Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.
id
EG000
other Num Affected
566
other Num At Risk
608
serious Num Affected
3
serious Num At Risk
608
title
9vHPV Vaccine - Base Study
description
Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
id
EG001
other Num Affected
197
other Num At Risk
305
serious Num Affected
3
serious Num At Risk
305
title
Placebo - Base Study
description
Participants who received placebo in Base Study and elected to have open-label 9vHPV vaccination in Extension Study.
id
EG002
other Num Affected
0
other Num At Risk
99
serious Num Affected
2
serious Num At Risk
99
title
9vHPV Vaccine - Extension Study

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 14.0
stats
group Id
EG000
num Affected
52
num At Risk
608
num Events
67
group Id
EG001
num Affected
12
num At Risk
305
num Events
13
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA Version 14.0
stats
group Id
EG000
num Affected
258
num At Risk
608
num Events
420
group Id
EG001
num Affected
26
num At Risk
305
num Events
33
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
term
Injection site erythema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA Version 14.0
stats
group Id
EG000
num Affected
549
num At Risk
608
num Events
1392
group Id
EG001
num Affected
117
num At Risk
305
num Events
182
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
term
Injection site pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA Version 14.0
stats
group Id
EG000
num Affected
48
num At Risk
608
num Events
68
group Id
EG001
num Affected
4
num At Risk
305
num Events
5
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
term
Injection site pruritus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA Version 14.0
stats
group Id
EG000
num Affected
298
num At Risk
608
num Events
558
group Id
EG001
num Affected
18
num At Risk
305
num Events
27
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
term
Injection site swelling
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA Version 14.0
stats
group Id
EG000
num Affected
42
num At Risk
608
num Events
50
group Id
EG001
num Affected
10
num At Risk
305
num Events
10
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 14.0
stats
group Id
EG000
num Affected
47
num At Risk
608
num Events
55
group Id
EG001
num Affected
19
num At Risk
305
num Events
20
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
term
Nasopharyngitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA Version 14.0
stats
group Id
EG000
num Affected
31
num At Risk
608
num Events
34
group Id
EG001
num Affected
6
num At Risk
305
num Events
8
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
term
Dizziness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA Version 14.0
stats
group Id
EG000
num Affected
190
num At Risk
608
num Events
318
group Id
EG001
num Affected
81
num At Risk
305
num Events
150
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
term
Headache
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA Version 14.0
stats
group Id
EG000
num Affected
40
num At Risk
608
num Events
46
group Id
EG001
num Affected
12
num At Risk
305
num Events
14
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
term
Oropharyngeal pain

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 14.0
stats
group Id
EG000
num Affected
1
num At Risk
608
num Events
1
group Id
EG001
num Affected
0
num At Risk
305
num Events
0
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
term
Appendicitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 14.0
stats
group Id
EG000
num Affected
1
num At Risk
608
num Events
1
group Id
EG001
num Affected
0
num At Risk
305
num Events
0
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
term
Tonsillitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA Version 14.0
stats
group Id
EG000
num Affected
0
num At Risk
608
num Events
0
group Id
EG001
num Affected
1
num At Risk
305
num Events
1
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
term
Lumbar vertebral fracture
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA Version 14.0
stats
group Id
EG000
num Affected
0
num At Risk
608
num Events
0
group Id
EG001
num Affected
1
num At Risk
305
num Events
1
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
term
Thoracic vertebral fracture
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA Version 14.0
stats
group Id
EG000
num Affected
0
num At Risk
608
num Events
0
group Id
EG001
num Affected
1
num At Risk
305
num Events
1
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
term
Migraine
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA Version 14.0
stats
group Id
EG000
num Affected
1
num At Risk
608
num Events
1
group Id
EG001
num Affected
0
num At Risk
305
num Events
0
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
term
Syncope
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Surgical and medical procedures
source Vocabulary
MedDRA Version 14.0
stats
group Id
EG000
num Affected
0
num At Risk
608
num Events
0
group Id
EG001
num Affected
1
num At Risk
305
num Events
1
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
term
Abortion induced
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 14.0
stats
group Id
EG000
num Affected
0
num At Risk
608
num Events
0
group Id
EG001
num Affected
0
num At Risk
305
num Events
0
group Id
EG002
num Affected
1
num At Risk
99
num Events
1
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 14.0
stats
group Id
EG000
num Affected
0
num At Risk
608
num Events
0
group Id
EG001
num Affected
0
num At Risk
305
num Events
0
group Id
EG002
num Affected
1
num At Risk
99
num Events
1
term
Diarrhoea

time Frame

Up to 5 days after any vaccination (Non-serious injection site AEs); up to 15 days after any vaccination (Non-serious systemic AEs) and up to 7 months (Serious AEs) - Base Study and Extension Study

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