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 @ 9:10 PM
Ignite Modification Date:
2025-12-25 @ 7:00 PM
NCT ID:
NCT01218204
Description:
All AEs and SAEs for Part A were collected using Safety Population and for Part B using All Subjects Population.
Frequency Threshold:
0
Time Frame:
All AEs and SAEs were collected up to follow-up visit. For Part A- up to Day 26, for Part B (washout)- up to Day 28, for Part B (run-in)- up to day up to day 28 and Part B (treatment)- up to Day 26
Study:
NCT01218204
Study Brief:
A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Administering Multiple Oral Doses of GSK1292263 Alone and With Atorvastatin
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| 80 mg Atorvastatin + 800 mg GSK1292263 (Part A) | Participants on 80 mg atorvastatin (either for \>=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg) received 800 mg of GSK1292263 for 2 weeks once daily immediately after eating the breakfast meal. | 0 | None | 0 | 4 | 0 | 4 | View |
| 800 mg GSK1292263 (Part A) | Participants not on lipid-modifying treatment received GSK1282263 alone for 2 weeks once daily immediately after eating the breakfast meal. | 0 | None | 0 | 2 | 2 | 2 | View |
| Pre-treatment (Part B) | This was the time period prior to Day 1 of Washout Phase. | 0 | None | 0 | 281 | 14 | 281 | View |
| Washout (Part B) | During the 4 weeks washout period, participants were asked to stop their lipid-modifying drugs. | 0 | None | 0 | 281 | 37 | 281 | View |
| Atorvastatin 10 mg (Part B Run-in) | After washout participants received atorvastatin 10 mg for a 4-week stabilization Run-in Period. | 0 | None | 0 | 62 | 19 | 62 | View |
| Atorvastatin 80 mg (Part B Run-in) | After washout participants received atorvastatin 80 mg for a 4-week stabilization Run-in Period. | 0 | None | 0 | 27 | 8 | 27 | View |
| Atorvastatin 10 mg + GSK1292263 100 mg (Part B Treatment) | Participants received 10 mg atorvastatin along with GSK1292263 100 mg once daily for 2 weeks. | 0 | None | 0 | 11 | 6 | 11 | View |
| Atorvastatin 10 mg + GSK1292263 300 mg (Part B Treatment) | Participants received 10 mg atorvastatin along with GSK1292263 300 mg once daily for 2 weeks. | 0 | None | 0 | 11 | 2 | 11 | View |
| Atorvastatin 10 mg + GSK1292263 800 mg (Part B Treatment) | Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks. | 0 | None | 0 | 11 | 3 | 11 | View |
| Atorvastatin 10 mg + Placebo (Part B Treatment) | Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks. | 0 | None | 0 | 12 | 3 | 12 | View |
| Atorvastatin 10 mg + Ezetimibe 10 mg (Part B Treatment) | Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks. | 0 | None | 0 | 13 | 4 | 13 | View |
| Atorvastatin 80 mg + GSK1292263 800 mg (Part B Treatment) | Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks. | 0 | None | 0 | 12 | 6 | 12 | View |
| Atorvastatin 80 mg + Placebo (Part B Treatment) | Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks. | 0 | None | 0 | 13 | 4 | 13 | View |
| GSK1292263 100 mg (Part B Treatment) | After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks. | 0 | None | 0 | 11 | 5 | 11 | View |
| GSK1292263 300 mg (Part B Treatment) | After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks. | 0 | None | 0 | 12 | 7 | 12 | View |
| GSK1292263 800 mg (Part B Treatment) | After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks. | 0 | None | 0 | 13 | 8 | 13 | View |
| Placebo (Part B Treatment) | After washout, participants were randomized to receive placebo matching to GSK1292263 once daily for 2 weeks. | 0 | None | 0 | 11 | 4 | 11 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| Phlebitis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 14.1 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.1 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.1 | View |
| Breast abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.1 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.1 | View |
| Helicobacter infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.1 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.1 | View |
| Injection site infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.1 | View |
| Lower respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.1 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.1 | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.1 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.1 | View |
| Tooth infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.1 | View |
| Toothache | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| Abdominal distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| Abdominal pain lower | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| Flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.1 | View |
| Migraine | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.1 | View |
| Arthropod bite | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 14.1 | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 14.1 | View |
| Excoriation | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 14.1 | View |
| Muscle strain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 14.1 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | View |
| Musculoskeletal discomfort | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | View |
| Musculoskeletal stiffness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | View |
| Neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | View |
| Haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 14.1 | View |
| Pollakiuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 14.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | View |
| Sinus congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | View |
| Throat irritation | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.1 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.1 | View |
| Blood pressure increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 14.1 | View |
| Cardiac murmur | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 14.1 | View |
| Middle ear effusion | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 14.1 | View |
| Sinus headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| Tongue ulceration | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | View |
| Musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | View |
| Osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | View |
| Viral infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.1 | View |
| Viral upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.1 | View |
| Laceration | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 14.1 | View |
| Productive cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 14.1 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 14.1 | View |
| Vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 14.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.1 | View |
| Dermatitis contact | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 14.1 | View |
| Hot flush | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 14.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.1 | View |
| Hypersomnia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.1 | View |
| Somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.1 | View |
| VIIth nerve paralysis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.1 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| Gingival pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.1 | View |
| Muscular weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | View |
| Rhinorrhoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | View |
| Rhinitis allergic | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | View |
| Sneezing | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | View |
| Upper-airway cough syndrome | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | View |
| Hordeolum | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.1 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 14.1 | View |
| Dermatitis contact | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 14.1 | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 14.1 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 14.1 | View |
| Urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 14.1 | View |
| Flushing | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 14.1 | View |
| Blood calcium decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 14.1 | View |
| Blood creatine phosphokinase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 14.1 | View |
| Hypoglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 14.1 | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 14.1 | View |
| Sleep disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 14.1 | View |
| Confusional state | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 14.1 | View |
| Personality change | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 14.1 | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 14.1 | View |
| Hypoacusis | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 14.1 | View |
| Lacrimation increased | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 14.1 | View |
| Vaginal haemorrhage | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 14.1 | View |