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NCT01185782 · ADVERSE EVENTS

Adverse events

SJ-0021 (Gonalef®) Versus Purified Pituitary Gonadotropin (Fertinorm-P®) for Ovulation Induction in Japanese Infertile Women · Source last updated 2013-12-27

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
AEs were collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until the final post-treatment examination, on Day 35-42 of the post-treatment assessment period.
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
SJ-0021

SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.

1 / 12936 / 129Not reported / Not reported
u-hFSH

Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.

1 / 13240 / 132Not reported / Not reported

Group identifiers: EG000: SJ-0021 · EG001: u-hFSH

Serious adverse events

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

  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Reproductive system and breast disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      129
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      132
      num Events
      1
    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.

  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      129
      num Events
      7
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      132
      num Events
      17
    term
    Abdominal pain lower
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      129
      num Events
      10
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      132
      num Events
      7
    term
    Abdominal distension
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      129
      num Events
      4
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      132
      num Events
      7
    term
    Ascites
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      129
      num Events
      10
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      132
      num Events
      11
    term
    Nasopharyngitis
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      129
      num Events
      6
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      132
      num Events
      9
    term
    Headache
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Reproductive system and breast disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      129
      num Events
      9
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      132
      num Events
      4
    term
    Ovarian hyperstimulation syndrome
Complete source fields
event Groups
  1. description
    SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
    id
    EG000
    other Num Affected
    36
    other Num At Risk
    129
    serious Num Affected
    1
    serious Num At Risk
    129
    title
    SJ-0021
  2. description
    Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
    id
    EG001
    other Num Affected
    40
    other Num At Risk
    132
    serious Num Affected
    1
    serious Num At Risk
    132
    title
    u-hFSH
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      129
      num Events
      7
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      132
      num Events
      17
    term
    Abdominal pain lower
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      129
      num Events
      10
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      132
      num Events
      7
    term
    Abdominal distension
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      129
      num Events
      4
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      132
      num Events
      7
    term
    Ascites
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      129
      num Events
      10
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      132
      num Events
      11
    term
    Nasopharyngitis
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      129
      num Events
      6
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      132
      num Events
      9
    term
    Headache
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Reproductive system and breast disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      129
      num Events
      9
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      132
      num Events
      4
    term
    Ovarian hyperstimulation syndrome
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Reproductive system and breast disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      129
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      132
      num Events
      1
    term
    Ovarian hyperstimulation syndrome
time Frame
AEs were collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until the final post-treatment examination, on Day 35-42 of the post-treatment assessment period.

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Preserved source evidence · Not medical advice