Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2025-12-25 @ 5:17 PM
NCT ID:
NCT03692403
Description:
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
Frequency Threshold:
5
Time Frame:
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Study:
NCT03692403
Study Brief:
Randomized Trial Assessing Quinagolide Vaginal Ring for Endometriosis-related Pain
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Quinagolide 720 µg - Part A | Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases. Part A is cycle 1-4. | 0 | None | 0 | 5 | 3 | 5 | View |
| Placebo - Part A | Vaginal ring containing matching placebo Placebo: Matching placebo. Only Part A. No participants were exposed to placebo vaginal ring during Part B of the trial. | 0 | None | 0 | 3 | 2 | 3 | View |
| Quinagolide 360 µg - Part B | Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases Part B is cycle 5-8. | 0 | None | 0 | 3 | 1 | 3 | View |
| Quinagolide 1080 µg - Part A | Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases. Part A is cycle 1-4. | 0 | None | 0 | 8 | 2 | 8 | View |
| Quinagolide 720 µg - Part B | Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases. Part B is cycle 5-8. 2 participants received Quinagolide 720 µg for both Part A and Part B (8 cycles total) and 1 participant received placebo for Part A (4 cycles) and Quinagolide 720 µg for Part B (4 cycles). | 0 | None | 0 | 3 | 2 | 3 | View |
| Quinagolide 1080 µg - Part B | Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases. Part B is cycle 5-8. 6 participants received Quinagolide 1080 µg for both Part A and Part B (8 cycles total) and 1 participant received placebo for Part A (4 cycles) and Quinagolide 1080 µg for Part B (4 cycles). | 0 | None | 0 | 7 | 5 | 7 | View |
| Quinagolide 360 µg - Part A | Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases Part A is cycle 1-4. | 0 | None | 0 | 6 | 4 | 6 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.0 | View |
| Vulvovaginal mycotic infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Conjunctivitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Gastroenteritis viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Pharyngitis streptococcal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Viral upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Exposure during pregnancy | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.0 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 20.0 | View |
| Pollakiuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 20.0 | View |
| Genital burning sensation | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 20.0 | View |
| Ovarian cyst | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 20.0 | View |
| Vaginal haemorrhage | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 20.0 | View |
| Vaginal odour | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 20.0 | View |
| Vulvovaginal pruritus | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 20.0 | View |
| Dermal cyst | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.0 | View |
| Dermatitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.0 | View |
| Dermatitis allergic | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.0 | View |
| Corona virus infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Fungal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Mastitis bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Pharyngitis bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Arthropod bite | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.0 | View |
| Foot fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.0 | View |
| Umbilical granuloma | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 20.0 | View |
| obsessive-compulsive symptom | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 20.0 | View |
| Major depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 20.0 | View |
| Bacterial vaginosis | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 20.0 | View |
| Uterine disorder | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 20.0 | View |