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 @ 11:43 PM
Ignite Modification Date:
2025-12-25 @ 9:35 PM
NCT ID:
NCT03334851
Description:
None
Frequency Threshold:
5
Time Frame:
From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Study:
NCT03334851
Study Brief:
Safety and Tolerability Study Of PF-06835375 In Subjects With Seropositive Systemic Lupus Erythematosus Or Rheumatoid Arthritis
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| PF-06835375 0.03 mg IV SAD | Participants received single dose of PF-06835375 0.03 mg on Day 1 as an IV infusion. | 0 | None | 1 | 3 | 3 | 3 | View |
| PF-06835375 0.1 mg IV SAD | Participants received single dose of PF-06835375 0.1 mg on Day 1 as an IV infusion. | 0 | None | 0 | 3 | 3 | 3 | View |
| PF-06835375 0.3 mg IV SAD | Participants received single dose of PF-06835375 0.3 mg on Day 1 as an IV infusion. | 0 | None | 1 | 3 | 2 | 3 | View |
| PF-06835375 1 mg IV SAD | Participants received single dose of PF-06835375 1 mg on Day 1 as an IV infusion. | 0 | None | 0 | 3 | 3 | 3 | View |
| PF-06835375 3 mg IV SAD | Participants received single dose of PF-06835375 3 mg on Day 1 as an IV infusion. | 0 | None | 0 | 6 | 6 | 6 | View |
| PF-06835375 6 mg IV SAD | Participants received single dose of PF-06835375 6 mg on Day 1 as an IV infusion. | 0 | None | 0 | 5 | 5 | 5 | View |
| Placebo SC MAD | Participants received two doses of placebo subcutaneously (SC) with first dose on Day 1 and the repeated dose on Day 29. | 0 | None | 0 | 11 | 9 | 11 | View |
| PF-06835375 0.3 mg SC MAD | Participants received two doses of PF-06835375 0.3 mg SC with first dose on Day 1 and the repeated dose on Day 29. | 0 | None | 0 | 6 | 4 | 6 | View |
| PF-06835375 1 mg SC MAD | Participants received two doses of PF-06835375 1 mg SC with first dose on Day 1 and the repeated dose on Day 29. | 0 | None | 0 | 6 | 4 | 6 | View |
| PF-06835375 3 mg SC MAD | Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29. | 0 | None | 0 | 7 | 5 | 7 | View |
| PF-06835375 6 mg SC MAD | Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29. | 0 | None | 0 | 6 | 4 | 6 | View |
| PF-06835375 10 mg SC MAD | Participants received two doses of PF-06835375 10 mg SC with first dose on Day 1 and the repeated dose on Day 29. | 0 | None | 0 | 6 | 6 | 6 | View |
| Placebo IV SAD | Participants received single dose of placebo on Day 1 as an intravenous (IV) infusion. | 0 | None | 1 | 8 | 8 | 8 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Acute myocardial infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v24.1 | View |
| Chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v24.1 | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | View |
| Neck pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v24.1 | View |
| Arteriosclerosis coronary artery | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v24.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Lymphopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v24.1 | View |
| Neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v24.1 | View |
| Palpitations | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v24.1 | View |
| Sinus tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v24.1 | View |
| Tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v24.1 | View |
| Eye irritation | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v24.1 | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v24.1 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v24.1 | View |
| Lip swelling | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v24.1 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v24.1 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v24.1 | View |
| Chest discomfort | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v24.1 | View |
| Chills | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v24.1 | View |
| Feeling hot | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v24.1 | View |
| Influenza like illness | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v24.1 | View |
| Injection site bruising | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v24.1 | View |
| Injection site pruritus | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v24.1 | View |
| Injection site scab | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v24.1 | View |
| Injection site swelling | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v24.1 | View |
| Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v24.1 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v24.1 | View |
| Cytokine release syndrome | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA v24.1 | View |
| Hypersensitivity | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA v24.1 | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| Contusion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v24.1 | View |
| Electrocardiogram T wave amplitude decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v24.1 | View |
| Heart rate increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v24.1 | View |
| Hepatic enzyme increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v24.1 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v24.1 | View |
| Dysgeusia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v24.1 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v24.1 | View |
| Confusional state | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v24.1 | View |
| Pollakiuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v24.1 | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | View |
| Nasal congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | View |
| Sinus congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v24.1 | View |
| Skin burning sensation | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v24.1 | View |
| Flushing | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v24.1 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v24.1 | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v24.1 | View |
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v24.1 | View |
| Iron deficiency anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v24.1 | View |
| Angina pectoris | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v24.1 | View |
| Ear pain | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA v24.1 | View |
| Hyperparathyroidism secondary | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA v24.1 | View |
| Keratitis | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v24.1 | View |
| Ocular hyperaemia | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v24.1 | View |
| Abdominal distension | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v24.1 | View |
| Abdominal pain lower | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v24.1 | View |
| Abdominal pain upper | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v24.1 | View |
| Anal haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v24.1 | View |
| Colitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v24.1 | View |
| Dry mouth | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v24.1 | View |
| Dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v24.1 | View |
| Dysphagia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v24.1 | View |
| Gastrointestinal disorder | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v24.1 | View |
| Gastrointestinal inflammation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v24.1 | View |
| Gastrooesophageal reflux disease | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v24.1 | View |
| Haemorrhoids | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v24.1 | View |
| Melaena | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v24.1 | View |
| Mouth ulceration | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v24.1 | View |
| Oesophageal stenosis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v24.1 | View |
| Rectal haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v24.1 | View |
| Disease progression | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v24.1 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v24.1 | View |
| Injection site erythema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v24.1 | View |
| Injection site pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v24.1 | View |
| Injection site reaction | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v24.1 | View |
| Malaise | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v24.1 | View |
| Mass | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v24.1 | View |
| Oedema peripheral | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v24.1 | View |
| Swelling | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v24.1 | View |
| Tenderness | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v24.1 | View |
| Vaccination site erythema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v24.1 | View |
| Vaccination site induration | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v24.1 | View |
| Vaccination site nodule | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v24.1 | View |
| Vaccination site pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v24.1 | View |
| Vaccination site swelling | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v24.1 | View |
| Vaccination site warmth | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v24.1 | View |
| Cholelithiasis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA v24.1 | View |
| Gallbladder disorder | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA v24.1 | View |
| Allergy to vaccine | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA v24.1 | View |
| Acute sinusitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| Bacterial vulvovaginitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| Gastroenteritis viral | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| Gastrointestinal viral infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| Herpes simplex | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| Oral herpes | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| Otitis media | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| Sinusitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| Tonsillitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| Tooth abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| Viral infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| Viral upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| Fall | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v24.1 | View |
| Ligament sprain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v24.1 | View |
| Muscle strain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v24.1 | View |
| Skin abrasion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v24.1 | View |
| Vaccination complication | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v24.1 | View |
| Blood creatine phosphokinase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v24.1 | View |
| Liver function test increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v24.1 | View |
| Hypercholesterolaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v24.1 | View |
| Hypocalcaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v24.1 | View |
| Hypokalaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v24.1 | View |
| Vitamin B12 deficiency | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v24.1 | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | View |
| Bone pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | View |
| Bursitis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | View |
| Flank pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | View |
| Joint swelling | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | View |
| Rheumatoid arthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | View |
| Spinal osteoarthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | View |
| Systemic lupus erythematosus | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | View |
| Migraine | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v24.1 | View |
| Paraesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v24.1 | View |
| Presyncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v24.1 | View |
| Device malfunction | NON_SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA v24.1 | View |
| Depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v24.1 | View |
| Hallucination, visual | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v24.1 | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v24.1 | View |
| Haematuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v24.1 | View |
| Hydronephrosis | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v24.1 | View |
| Hypercalciuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v24.1 | View |
| Nocturia | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v24.1 | View |
| Renal colic | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v24.1 | View |
| Stag horn calculus | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v24.1 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | View |
| Oropharyngeal pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | View |
| Pulmonary mass | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | View |
| Dermatitis contact | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v24.1 | View |
| Dry skin | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v24.1 | View |
| Erythema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v24.1 | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v24.1 | View |
| Tooth extraction | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA v24.1 | View |
| Thrombosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v24.1 | View |