Study: NCT02749292

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 58 at risk

Adverse event: Urinary Track Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 58 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 58 at risk

Adverse event: Skin infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 58 at risk

Adverse event: COVID-19
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 58 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Squamous cell carcinoma
Frequency: 1 affected / 58 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 58 at risk

Adverse event: Death
Serious: yes
Organ System: Infections and infestations
Notes: all were due to COVID-19
Frequency: 2 affected / 58 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 58 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 58 at risk

Adverse event: Pulmonary edema in setting of fluid resuscitation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 58 at risk

Adverse event: Biliary colic
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 58 at risk

Adverse event: Lumbar disc herniation, cervical and lumbar stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 58 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 58 at risk

Adverse event: New elevated IgM in setting of longstanding pancytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 58 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 58 at risk

Adverse event: Coronary artery disease- Three-vessel disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 58 at risk

Adverse event: Myocarditis and Heart failure with preserved ejection fraction
Serious: yes
Organ System: Cardiac disorders
Notes: Myocarditis was the first diagnosis. New diagnosis of HFpEF later on.
Frequency: 1 affected / 58 at risk

Adverse event: Upper Respiratory Infection (Cold)
Serious: no
Organ System: Infections and infestations
Notes: Cold, pharyngitis and other URI. Sinusitis are not included if isolated and specified in the description of event.
Frequency: 21 affected / 58 at risk

Adverse event: Urinary Track Infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 58 at risk

Adverse event: Gout
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 58 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 58 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 58 at risk

Adverse event: COVID-19 Positive
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 58 at risk

Adverse event: Allergic Reaction to Rituximab Infusion
Serious: no
Organ System: Immune system disorders
Frequency: 3 affected / 58 at risk

Adverse event: Allergic reaction unrelated to Rituximab
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 58 at risk

Adverse event: Vaginal infection
Serious: no
Organ System: Infections and infestations
Notes: One due to yeasts, for the two other the cause is unknown
Frequency: 1 affected / 58 at risk

Adverse event: Asymptomatic Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 58 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 58 at risk

Adverse event: Mild fatty replacement of the liver
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 58 at risk

Adverse event: Metacarpophalangeal tenderness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Right 1st MCP
Frequency: 1 affected / 58 at risk

Adverse event: Headache/ Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 58 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 58 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 58 at risk

Adverse event: Fall injury
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: * Hip and back pain
* thumb fracture and hit head without LOC, headaches or confusion
* shoulder injury
Frequency: 2 affected / 58 at risk

Adverse event: Nephrolithiasis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 58 at risk

Adverse event: Rash in distribution of trigeminal nerve - consistent with zoster
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 58 at risk

Adverse event: Hypotension, fatigue, cough, HA, fever, malaise, volume depletion from high dose valtrex reaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 58 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 58 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 58 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 58 at risk

Adverse event: Jaw swelling,
Serious: no
Organ System: Immune system disorders
Notes: internal swelling and sensation of fullness in jaw. Related AE, led to stop cephalexin.
Frequency: 1 affected / 58 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Notes: Stomach discomfort. Mild ache and cramping pain over last month. Patient noted start coincided with switch to amlodipine
Frequency: 1 affected / 58 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Infections and infestations
Notes: sore throat; symptoms consistent of swollen lymph node, likely secondary viral or bacterial infection.
Frequency: 1 affected / 58 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Notes: Non serious and moderate
Frequency: 2 affected / 58 at risk

Adverse event: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 58 at risk

Adverse event: Vertigo
Serious: no
Organ System: General disorders
Frequency: 1 affected / 58 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 58 at risk

Adverse event: Colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 58 at risk

Adverse event: Lung opacity and nodule
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 58 at risk

Adverse event: Dizziness
Serious: no
Organ System: Investigations
Frequency: 1 affected / 58 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 58 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 58 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 58 at risk

Adverse event: Ear pain
Serious: no
Organ System: Infections and infestations
Notes: Possibly due to infection
Frequency: 1 affected / 58 at risk

Adverse event: Surgery
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 58 at risk

Adverse event: Tooth infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 58 at risk

Adverse event: Skin rash on arms and legs
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Raised red rash on bilateral arms and legs. Not itchy or painful. Lesions come and go
Frequency: 1 affected / 58 at risk

Adverse event: Tendon pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Bilateral Achilles tendon pain. Patient had taken levaquin \~1 month prior
Frequency: 1 affected / 58 at risk

Adverse event: Prostatic obstruction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 58 at risk

Adverse event: Herpes simplex virus rash
Serious: no
Organ System: Infections and infestations
Notes: Herpes simplex virus. Vesicular rash on lower lip and chin. Mostly on left and on midline
Frequency: 1 affected / 58 at risk

Adverse event: Bilateral impacted cerumen
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 58 at risk

Adverse event: Herpes simplex cold sore
Serious: no
Organ System: Infections and infestations
Notes: Cold sore on lip, treated with valtrex
Frequency: 1 affected / 58 at risk

Adverse event: Ankle soreness and swelling post exercize
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Left ankle soreness with severe swelling after walking a lot in France
Frequency: 1 affected / 58 at risk

Adverse event: Arthritis
Serious: no
Organ System: Immune system disorders
Notes: New left acute knee arthritis. Initially thought consistent with gout, but patient on uloric for past 2 years. Uric acid 5.5
Frequency: 1 affected / 58 at risk

Adverse event: Sores in mouth
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Sores in mouth attributed to Invisalign
Frequency: 1 affected / 58 at risk

Adverse event: Infection lower eye lid
Serious: no
Organ System: Infections and infestations
Notes: Treated with polymyxin drops
Frequency: 1 affected / 58 at risk

Adverse event: Infection on left side of the face
Serious: no
Organ System: Infections and infestations
Notes: Non serious, related and treated with 5 days of antibiotics.
Frequency: 1 affected / 58 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Notes: Shingles. C4 distribution. Right
Frequency: 1 affected / 58 at risk

Adverse event: Rash on chest - Allergy
Serious: no
Organ System: Immune system disorders
Notes: Rash on chest for 5 days. Pt believes caused by perfume or lotion
Frequency: 1 affected / 58 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 57 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 57 at risk

Adverse event: Urinary Track Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 57 at risk

Adverse event: COVID-19
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 57 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Thromboembolic disease
Frequency: 1 affected / 57 at risk

Adverse event: Psychiatric Disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 57 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 57 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 57 at risk

Adverse event: Gastric haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 57 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 57 at risk

Adverse event: Urinary retention and elevated creatinine
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 57 at risk

Adverse event: Rectal bleeding status post colonoscopy
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 57 at risk

Adverse event: bleeding gastric nodule
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 57 at risk

Adverse event: Asymptomatic AKI
Serious: yes
Organ System: Renal and urinary disorders
Notes: Cr to 1.9 from baseline 1.5. Kidney biopsy 10/22/19 showed chronic active interstitial nephritis
Frequency: 1 affected / 57 at risk

Adverse event: Gallstone pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 57 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 57 at risk

Adverse event: Chest pain, LAD stenosis and RAD stenosis
Serious: yes
Organ System: Cardiac disorders
Notes: Admitted with chest pain - arteriogram at cath lab found LAD: 99% mid LAD stenosis; RCA: 95% stenosis with an early branching acute marginal.
Frequency: 1 affected / 57 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 57 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 57 at risk

Adverse event: Upper Respiratory Infection (Cold)
Serious: no
Organ System: Infections and infestations
Notes: Cold, pharyngitis and other URI. Sinusitis are not included if isolated and specified in the description of event.
Frequency: 17 affected / 57 at risk

Adverse event: Urinary Track Infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 57 at risk

Adverse event: Gout
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 57 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 57 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 57 at risk

Adverse event: COVID-19 Positive
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 57 at risk

Adverse event: Allergic Reaction to Rituximab Infusion
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 57 at risk

Adverse event: Vaginal infection
Serious: no
Organ System: Infections and infestations
Notes: One due to yeasts, for the two other the cause is unknown
Frequency: 2 affected / 57 at risk

Adverse event: Right thigh pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Mild, not injury related, for 2 days and resolved.
Frequency: 1 affected / 57 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 57 at risk

Adverse event: Heart murmurs
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 57 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 57 at risk

Adverse event: Pleural infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 57 at risk

Adverse event: Myalgias and arthralgias. Severe pains and frank arthritis in knees.
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 57 at risk

Adverse event: Pleuritic chest pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: CTA scan negative for PE but positive for pleural inflammatory process
Frequency: 1 affected / 57 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 57 at risk

Adverse event: Conduction disorder (LBBB)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 57 at risk

Adverse event: Fall injury
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: * Hip and back pain
* thumb fracture and hit head without LOC, headaches or confusion
* shoulder injury
Frequency: 2 affected / 57 at risk

Adverse event: colonoscopy finding:tubulovillous adenomatous colon poplyp
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 57 at risk

Adverse event: Urine cx positive for E.coli
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 57 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 57 at risk

Adverse event: Paronychia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 57 at risk

Adverse event: Elevated Liver Function Tests
Serious: no
Organ System: Hepatobiliary disorders
Notes: LFTs for each patients:

* ALT 144. AST 82. Patient stopped taking supplement
* ALT 62. Resolved at next visit
* ALT 225, AST 192, Alk-Phos 174
Frequency: 3 affected / 57 at risk

Adverse event: Mandibular pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 57 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 57 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 57 at risk

Adverse event: Distal Ventricular Tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: New edema and clot in lower leg near ankle
Frequency: 1 affected / 57 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Notes: Non serious and moderate
Frequency: 1 affected / 57 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 57 at risk

Adverse event: RLL possibe airspace disease and/or atelectasis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 57 at risk

Adverse event: Degenerative disk disease of c-spine
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 57 at risk

Adverse event: Dizziness
Serious: no
Organ System: Investigations
Frequency: 2 affected / 57 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 57 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 57 at risk

Adverse event: Ear pain
Serious: no
Organ System: Infections and infestations
Notes: Possibly due to infection
Frequency: 1 affected / 57 at risk

Adverse event: Surgery
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 57 at risk

Adverse event: Atrial flutter
Serious: no
Organ System: Cardiac disorders
Notes: Annual ECG with new atrial flutter. Patient asymptomatic
Frequency: 1 affected / 57 at risk

Adverse event: Shoulder cyst
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Shoulder cyst. Now large and tense
Frequency: 1 affected / 57 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Notes: Atrial fibrillation Mild
Frequency: 1 affected / 57 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 57 at risk

Adverse event: Dyspnoea exertional
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Exertional dyspnea. Requires break after 1-2 blocks; a/w diaphoresis. DDx includes poorly controlled asthma vs deconditioning vs coronary disease
Frequency: 1 affected / 57 at risk

Adverse event: Heart palpitations
Serious: no
Organ System: Cardiac disorders
Notes: 3x/week for 3 weeks lasting less than 1 min. No pain, SOB or numbness.
Frequency: 1 affected / 57 at risk

Adverse event: Adrenal neoplasm
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 57 at risk

Adverse event: Conduction disorder- Non-specific intraventricular block
Serious: no
Organ System: Cardiac disorders
Notes: Non-specific intraventricular block (conduction disorder). QRS 128ms.
Frequency: 1 affected / 57 at risk

Adverse event: Balanoposthitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 57 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 57 at risk

Adverse event: Bilateral swelling in the ankle and high blood pressure
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 57 at risk

Adverse event: Esophageal narrowing
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 57 at risk

Adverse event: Recurrent Lightheadedness
Serious: no
Organ System: Vascular disorders
Notes: Patient experienced recurrent lightheadedness after increasing Losartan HCT from 50/12.5 to 100/25.
Frequency: 1 affected / 57 at risk

Adverse event: Cardiac arrythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 57 at risk

Adverse event: Polyarthritis
Serious: no
Organ System: Immune system disorders
Notes: Developed large toe arthritis then wrist, finger, ankle swelling.
Frequency: 1 affected / 57 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Notes: epigastric pain radiating to back and RUQ. Associated with nausea and 3 episodes emesis
Frequency: 1 affected / 57 at risk

Adverse event: Eye and face swelling
Serious: no
Organ System: Infections and infestations
Notes: Present to the ED with right eye swelling and pain. Right chin swelling and pain. Subject was prescribed doxycycline cyclate 100mg tablet
Frequency: 1 affected / 57 at risk

Adverse event: Arm, shoulder and neck pains
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: On and off, for 10 minutes. Not associated with exertion.
Frequency: 1 affected / 57 at risk

Adverse event: Syncopal episode
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 57 at risk

Adverse event: Scleritis
Serious: no
Organ System: Infections and infestations
Notes: Medial right eye scleritis treated emergently with prednisolone x 2 weeks, with improvement over 24 hours and no return of symptoms after drops stopped. Presented with gritty feeling whe blinking. Attributed to foreign body in eye
Frequency: 1 affected / 57 at risk