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NCT02413008 · ADVERSE EVENTS

Adverse events

A Clinical Trial to Assess the Safety of 0.005 % Estriol Vaginal Gel in Hormone Receptor-Positive Postmenopausal Women With Early Stage Breast Cancer in Treatment With Aromatase Inhibitor in the Adjuvant Setting · Source last updated 2019-08-05

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 baseline to last visit (up to 16 weeks)
Other-event reporting threshold
5%

AE: Any new untoward medical occurrence or worsening of a pre-existing medical condition in a patient or clinical investigation subject administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
0.005% Estriol Vaginal Gel

Route: Vaginal. Administration by an applicator inserted deep inside the vagina Dose: 1 g of gel, containing 50 Mcg of estriol Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: twice weekly administration

1 / 503 / 500 / 50
Placebo Vaginal Gel

Route: Vaginal. Administration by an applicator inserted deep inside the vagina Dose: 1 g of gel. Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: twice weekly administration Placebo

0 / 111 / 110 / 11

Group identifiers: EG000: 0.005% Estriol Vaginal Gel · EG001: Placebo Vaginal Gel

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
    SYSTEMATIC_ASSESSMENT
    notes
    An unrelated Serious adverse event (lymphoma) was reported but before study treatment administration
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    term
    Lymphoma

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
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      11
    term
    Urinary tract infection
Complete source fields
description
AE: Any new untoward medical occurrence or worsening of a pre-existing medical condition in a patient or clinical investigation subject administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment.
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    50
    description
    Route: Vaginal. Administration by an applicator inserted deep inside the vagina Dose: 1 g of gel, containing 50 Mcg of estriol Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: twice weekly administration
    id
    EG000
    other Num Affected
    3
    other Num At Risk
    50
    serious Num Affected
    1
    serious Num At Risk
    50
    title
    0.005% Estriol Vaginal Gel
  2. deaths Num Affected
    0
    deaths Num At Risk
    11
    description
    Route: Vaginal. Administration by an applicator inserted deep inside the vagina Dose: 1 g of gel. Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: twice weekly administration Placebo
    id
    EG001
    other Num Affected
    1
    other Num At Risk
    11
    serious Num Affected
    0
    serious Num At Risk
    11
    title
    Placebo Vaginal Gel
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      11
    term
    Urinary tract infection
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    An unrelated Serious adverse event (lymphoma) was reported but before study treatment administration
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    term
    Lymphoma
time Frame
From baseline to last visit (up to 16 weeks)

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice