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:
2025-12-25 @ 12:57 AM
Ignite Modification Date:
2025-12-25 @ 11:12 PM
NCT ID:
NCT02352493
Description:
None
Frequency Threshold:
0
Time Frame:
Part A: through day 658; Part B: through day 532; Part C: through day 280
Study:
NCT02352493
Study Brief:
A Phase 1/2 Study of an Investigational Drug, ALN-CC5, in Healthy Adult Volunteers and Patients With PNH
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Placebo - Single Ascending Dose | Healthy volunteers received a single dose of placebo (normal saline) | 0 | None | 0 | 8 | 6 | 8 | View |
| ALN-CC5 50mg (Japanese) - Single Ascending Dose | Japanese healthy volunteers received a single dose of ALN-CC5 50mg | 0 | None | 0 | 3 | 3 | 3 | View |
| ALN-CC5 200mg - Single Ascending Dose | Healthy volunteers received a single dose of ALN-CC5 200mg | 0 | None | 0 | 3 | 2 | 3 | View |
| ALN-CC5 200mg (Japanese) - Single Ascending Dose | Japanese healthy volunteers received a single dose of ALN-CC5 200mg | 0 | None | 0 | 3 | 2 | 3 | View |
| ALN-CC5 400mg - Single Ascending Dose | Healthy volunteers received a single dose of ALN-CC5 400mg | 0 | None | 0 | 3 | 3 | 3 | View |
| ALN-CC5 600mg - Single Ascending Dose | Healthy volunteers received a single dose of ALN-CC5 600mg | 0 | None | 0 | 3 | 3 | 3 | View |
| ALN-CC5 600mg (Japanese) - Single Ascending Dose | Japanese healthy volunteers received a single dose of ALN-CC5 600mg | 0 | None | 0 | 3 | 2 | 3 | View |
| ALN-CC5 900mg - Single Ascending Dose | Healthy volunteers received a single dose of ALN-CC5 900mg | 0 | None | 0 | 3 | 3 | 3 | View |
| Placebo - Multiple Ascending Dose | Healthy volunteers received multiple doses of placebo (normal saline) per corresponding active drug regimen | 0 | None | 0 | 6 | 6 | 6 | View |
| ALN-CC5 100mg Weekly - Multiple Ascending Dose | Healthy volunteers received weekly doses of ALN-CC5 100mg for 5 doses | 0 | None | 0 | 3 | 2 | 3 | View |
| ALN-CC5 200mg Weekly - Multiple Ascending Dose | Healthy volunteers received weekly doses of ALN-CC5 200mg for 5 doses | 0 | None | 0 | 3 | 3 | 3 | View |
| ALN-CC5 400mg Weekly - Multiple Ascending Dose | Healthy volunteers received weekly doses of ALN-CC5 400mg for 5 doses | 0 | None | 0 | 3 | 3 | 3 | View |
| ALN-CC5 600mg Biweekly - Multiple Ascending Dose | Healthy volunteers received biweekly doses of ALN-CC5 600mg for 7 doses | 0 | None | 0 | 3 | 3 | 3 | View |
| ALN-CC5 200mg Weekly/Biweekly - Multiple Ascending Dose | Healthy volunteers received weekly doses of ALN-CC5 200mg for 5 doses followed by biweekly doses of 200mg for 4 doses | 0 | None | 0 | 3 | 2 | 3 | View |
| ALN-CC5 Multiple Dose - Eculizumab Naive | Patients naive to eculizumab received weekly doses of ALN-CC5 400mg for 8 doses or weekly doses of ALN-CC5 200mg for 13 doses followed by weekly doses of ALN-CC5 400mg for 4 doses | 0 | None | 0 | 3 | 3 | 3 | View |
| ALN-CC5 50mg - Single Ascending Dose | Healthy volunteers received a single dose of ALN-CC5 50mg | 0 | None | 0 | 3 | 0 | 3 | View |
| ALN-CC5 200mg Weekly/Monthly - Multiple Ascending Dose | Healthy volunteers received weekly doses of ALN-CC5 200mg for 5 doses followed by monthly doses of 200mg for 2 doses | 0 | None | 0 | 3 | 3 | 3 | View |
| ALN-CC5 Multiple Dose - Eculizumab Treated | Patients received weekly doses of ALN-CC5 200mg or ALN-CC5 400mg for up to 12 weeks concomitantly with eculizumab | 0 | None | 0 | 3 | 3 | 3 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Fibroadenoma of breast | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.1) | View |
| Influenza like illness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.1) | View |
| Injection site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.1) | View |
| Injection site rash | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.1) | View |
| Injection site oedema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.1) | View |
| Chest discomfort | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.1) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.1) | View |
| Injection site bruising | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.1) | View |
| Injection site erythema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.1) | View |
| Injection site pruritus | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.1) | View |
| Injection site discomfort | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.1) | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.1) | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (17.1) | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (17.1) | View |
| Tendon injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (17.1) | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (17.1) | View |
| Sunburn | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (17.1) | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (17.1) | View |
| Amylase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (17.1) | View |
| Transaminases increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (17.1) | View |
| Haemolysis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (17.1) | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | View |
| Rhinorrhoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (17.1) | View |
| Somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (17.1) | View |
| Migraine | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (17.1) | View |
| VIIth nerve paralysis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (17.1) | View |
| Eye pruritus | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (17.1) | View |
| Vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (17.1) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.1) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.1) | View |
| Toothache | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.1) | View |
| Cheilitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.1) | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.1) | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.1) | View |
| Aphthous stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.1) | View |
| Abdominal discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.1) | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.1) | View |
| Choluria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (17.1) | View |
| Rash pruritic | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (17.1) | View |
| Drug eruption | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (17.1) | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (17.1) | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | View |
| Neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | View |
| Flank pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.1) | View |
| Vulvovaginal candidiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.1) | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.1) | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.1) | View |
| Lower respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.1) | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.1) | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.1) | View |
| Sensory disturbance | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (17.1) | View |
| Vessel puncture site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.1) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.1) | View |
| Eye discharge | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (17.1) | View |
| Eye swelling | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (17.1) | View |
| Vision blurred | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (17.1) | View |
| Throat irritation | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (17.1) | View |
| Ligament sprain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (17.1) | View |
| Head injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (17.1) | View |
| Seasonal allergy | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (17.1) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (17.1) | View |