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 @ 5:50 PM
Ignite Modification Date:
2025-12-25 @ 3:16 PM
NCT ID:
NCT02427568
Description:
None
Frequency Threshold:
5
Time Frame:
Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .
Study:
NCT02427568
Study Brief:
MDMA-Assisted Psychotherapy for Anxiety Associated With a Life-Threatening Illness
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| MDMA-assisted Therapy (125 mg) (Blinded) | 125 mg 3,4-methylenedioxymethamphetamine (MDMA) administered on 2 blinded experimental sessions scheduled 2 to 4 weeks apart. Initial dose possibly followed 1.5 to 2.5 hours later by a (optional) supplemental dose of 62.5 mg MDMA. MDMA-assisted therapy: Two sessions of MDMA-assisted therapy lasting six to eight hours, scheduled two to four weeks apart. | 0 | None | 0 | 13 | 11 | 13 | View |
| Placebo Group Open-label Crossover to Unblinded MDMA-assisted Therapy (125 mg) | Unblinded Crossover 125 mg 3,4-methylenedioxymethamphetamine (MDMA) administered on 3 open-label experimental sessions scheduled 2 to 4 weeks apart. Initial dose possibly followed 1.5 to 2.5 hours later by a (optional) supplemental dose of 62.5 mg MDMA. | 0 | None | 0 | 5 | 4 | 5 | View |
| MDMA Group Open-label MDMA-assisted Therapy (125 mg) | Open-Label 125 mg 3,4-methylenedioxymethamphetamine (MDMA) administered during open-label 1 experimental session. Initial dose possibly followed 1.5 to 2.5 hours later by a (optional) supplemental dose of 62.5 mg MDMA. | 0 | None | 0 | 13 | 3 | 13 | View |
| Placebo With Therapy Group 12-month Follow-up | Follow-up with placebo with therapy group 12 months after end of Stage 2. | 0 | None | 0 | 5 | 2 | 5 | View |
| MDMA-assisted Therapy Group 12-month Follow-up | Follow-up with MDMA-assisted therapy group 12 months after end of Stage 1. | 1 | None | 3 | 13 | 3 | 13 | View |
| Placebo With Therapy (Blinded) | Inactive placebo administered on 2 blinded experimental sessions scheduled 2 to 4 weeks apart. Initial dose possibly followed 1.5 to 2.5 hours later by (optional) inactive placebo supplemental dose. Placebo with therapy: Two sessions of placebo with therapy lasting six to eight hours, scheduled two to four weeks apart. | 0 | None | 0 | 5 | 2 | 5 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Intraductal proliferative breast lesion | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Cerebrovascular accident | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Spinal cord paralysis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Chordoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Meningitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Invasive ductal breast carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal Discomfort | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Arrhythmia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Abdominal Pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Back Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Balance Disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Bruxism | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Clumsiness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Depressed mood | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Dissociation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Hyperventilation | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Hypomania | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Lymphoedema | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Nephrolithiasis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Sinus Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Skin Abrasion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Tenosynovitis stenosans | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Tinea Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Tooth Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Vaginal Discharge | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Weight Decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Chest Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Muscle Spasm | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Neuropathy peripheral | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Plantar fasciitis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Skeletal injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Viral upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Intervertebral disc degeneration | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Heart rate irregular | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Muscle contractions | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Aphthous stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Oral herpes | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Hot flush | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Tremor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Drug abuse | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Sciatica | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Oesophageal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Thermal burn | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Scleroderma | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Aphasia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Post procedural cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |