NCT01653743 · ADVERSE EVENTS

Adverse events

Trial to Assess the Clinical Efficacy and Safety of MSJ-0011 in Inducing Ovulation in Anovulatory or Oligo-ovulatory Japanese Women · Source last updated 2016-01-07

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 signing of the informed consent document until Day 28-31 (for subjects who had a negative serum β-hCG pregnancy test on Day 15-20), or up to the Day 35-42 post hCG treatment (for subjects who have a positive serum β-hCG pregnancy test on Day 15-20).
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
MSJ-0011 Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 International Units (IU) subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received a single dose of 250 microgram (mcg) MSJ-0011 subcutaneously (SC) within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of greater than or equal to (\>=) 18 millimeter (mm); not more than 3 follicles each with a mean diameter of \>=16 mm and serum Estradiol (E2) level within an acceptable range for the number of follicle present, and not more than 2,000 picogram per milliliter (pg/mL).	1 / 54	32 / 54	Not reported / Not reported
u-hCG Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 IIU subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received a single dose of 5,000 IU u-hCG intramuscularly dose within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of \>=18 mm; not more than 3 follicles each with a mean diameter of \>=16 mm and serum E2 level within an acceptable range for the number of follicle present, and not more than 2,000 pg/mL.	0 / 27	11 / 27	Not reported / Not reported

Group identifiers: EG000: MSJ-0011 · EG001: u-hCG

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Reproductive system and breast disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
1
num At Risk
54
group Id
EG001
num Affected
0
num At Risk
27
term
Ovarian hyperstimulation syndrome

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
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
0
num At Risk
54
group Id
EG001
num Affected
1
num At Risk
27
term
Abdominal distension
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
2
num At Risk
54
group Id
EG001
num Affected
0
num At Risk
27
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
1
num At Risk
54
group Id
EG001
num Affected
0
num At Risk
27
term
Abdominal pain upper
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
1
num At Risk
54
group Id
EG001
num Affected
0
num At Risk
27
term
Ascites
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
2
num At Risk
54
group Id
EG001
num Affected
0
num At Risk
27
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
1
num At Risk
54
group Id
EG001
num Affected
0
num At Risk
27
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
1
num At Risk
54
group Id
EG001
num Affected
0
num At Risk
27
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
1
num At Risk
54
group Id
EG001
num Affected
0
num At Risk
27
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
1
num At Risk
54
group Id
EG001
num Affected
0
num At Risk
27
term
Injection site bruising
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
5
num At Risk
54
group Id
EG001
num Affected
2
num At Risk
27
term
Injection site erythema
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
2
num At Risk
54
group Id
EG001
num Affected
3
num At Risk
27
term
Injection site pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
1
num At Risk
54
group Id
EG001
num Affected
0
num At Risk
27
term
Injection site swelling

Complete source fields

event Groups

description
Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 International Units (IU) subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received a single dose of 250 microgram (mcg) MSJ-0011 subcutaneously (SC) within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of greater than or equal to (\>=) 18 millimeter (mm); not more than 3 follicles each with a mean diameter of \>=16 mm and serum Estradiol (E2) level within an acceptable range for the number of follicle present, and not more than 2,000 picogram per milliliter (pg/mL).
id
EG000
other Num Affected
32
other Num At Risk
54
serious Num Affected
1
serious Num At Risk
54
title
MSJ-0011
description
Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 IIU subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received a single dose of 5,000 IU u-hCG intramuscularly dose within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of \>=18 mm; not more than 3 follicles each with a mean diameter of \>=16 mm and serum E2 level within an acceptable range for the number of follicle present, and not more than 2,000 pg/mL.
id
EG001
other Num Affected
11
other Num At Risk
27
serious Num Affected
0
serious Num At Risk
27
title
u-hCG

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
0
num At Risk
54
group Id
EG001
num Affected
1
num At Risk
27
term
Abdominal distension
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
2
num At Risk
54
group Id
EG001
num Affected
0
num At Risk
27
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
1
num At Risk
54
group Id
EG001
num Affected
0
num At Risk
27
term
Abdominal pain upper
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
1
num At Risk
54
group Id
EG001
num Affected
0
num At Risk
27
term
Ascites
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
2
num At Risk
54
group Id
EG001
num Affected
0
num At Risk
27
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
1
num At Risk
54
group Id
EG001
num Affected
0
num At Risk
27
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
1
num At Risk
54
group Id
EG001
num Affected
0
num At Risk
27
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
1
num At Risk
54
group Id
EG001
num Affected
0
num At Risk
27
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
1
num At Risk
54
group Id
EG001
num Affected
0
num At Risk
27
term
Injection site bruising
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
5
num At Risk
54
group Id
EG001
num Affected
2
num At Risk
27
term
Injection site erythema
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
2
num At Risk
54
group Id
EG001
num Affected
3
num At Risk
27
term
Injection site pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
1
num At Risk
54
group Id
EG001
num Affected
0
num At Risk
27
term
Injection site swelling

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Reproductive system and breast disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
1
num At Risk
54
group Id
EG001
num Affected
0
num At Risk
27
term
Ovarian hyperstimulation syndrome

time Frame

From signing of the informed consent document until Day 28-31 (for subjects who had a negative serum β-hCG pregnancy test on Day 15-20), or up to the Day 35-42 post hCG treatment (for subjects who have a positive serum β-hCG pregnancy test on Day 15-20).

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Preserved source evidence · Not medical advice