Adverse Events Module

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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 @ 2:54 PM
Ignite Modification Date: 2025-12-25 @ 1:19 PM
NCT ID: NCT00114959
Description: None
Frequency Threshold: 0
Time Frame: Day 1 up to 3 years (30 days past last dose)
Study: NCT00114959
Study Brief: Homoharringtonine With Oral Gleevec in Chronic, Accelerated and Blast Phase Chronic Myeloid Leukemia (CML)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Homoharringtonine + Imatinib Mesylate Participants are administered homoharringtonine (omacetaxine) 2.5 mg/m\^2 by continuous 24-hour intravenous infusion daily on Days 1-5 of each 4 week treatment cycle, and imatinib mesylate (Gleevec) by mouth with a daily dose of 400 mg for participants in the chronic phase of chronic myeloid leukemia (CML) or 600 mg for participants in the accelerated or blast phase of CML. None None 12 15 15 15 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Pain, upper extremities SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Fever SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Gastrointestinal bleeding SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Hemorrhage, gastrointestinal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Fatal car accident SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Cerebral vascular event (fatal) SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Acute renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Sudden death SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Leukocytosis SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Neutropenic fever SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Infection SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Weakness SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Intra-cranial hemorrhage SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Pain, low back SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Allergies SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Bacteremia SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Bleeding at CVC site SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Bleeding at PICC line insertion site SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Bleeding at port site SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Bruising SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Chills, intermittent SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Citrobacter freundii positive SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Mild fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Severe fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Fever SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Fibromyalgia syndrome SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Fluid retention SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Generalized achiness SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Infection, Staphylococcus aureus SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Intermittent fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Intermittent fever SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pain, right hip SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pallor SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pseudomonas aeruginosa SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Runny nose SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Weakness SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Mildly weak SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Edema SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Edema, intermittent SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Edema, pedal SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Edema, ankle SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Edema, bilateral SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Edema, bilateral pedal SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Edema, bilateral legs + 2 pitting SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Edema, bilateral lower extremity SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Edema, lower extremity SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Edema, peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Edema, Intermittent trace peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Periorbital edema SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Right Arm Swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Right side face swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Severe thrombocytopenia SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Swelling, hands and feet SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Swelling, right arm SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Acanthosis nigricans SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Bruising skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Erythema, left foot SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Erythema, tonsils SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Hypopigmentation facial SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Itching due to transfusion SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Itching impaired SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Generalized skin itching SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Itchy ears SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Keratoderma, pedal SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Pedal calluses SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Mild rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Mouth sores SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Mouth sores, intermittent SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Mouth ulcerations SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Oral white patches SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Peeling skin, groin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Plantar surface skin sensitive SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Rash abdomen SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Rash, macular / facial SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Seborrheic keratosis, upper extremity SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Skin nodule SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Swelling, face SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Tinea SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Punctate lesion right foot dorsom SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Vesicular lesions, right buttock SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Yeast infection, buttock SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Abdominal bloating SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal discomfort intermittent SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal pain, interrmittent left sided SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Anorexia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Colon polyps SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Constipation, intermittent SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dry heaves SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Flatus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
GERD SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Hemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Hepatic Dysfunction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Indigestion SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Lack of appetite SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Poor appetite SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Suppressed appetite SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Loose stools SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Melena SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Mild nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Nausea, intermittent SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Pandiverticulosis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Rectal bleeding SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Renal failure SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Stomach discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Upset stomach SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vomiting, occasional SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Bruising SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Abdominal bruising, secondary to SC injections SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Decreased prothrombinemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Ecchymoses, mouth and arms SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Decreased hemaglobin SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Hematoma SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Hepatitis A SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Hypertriglyceridemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Intermittent anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Myelosuppression SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Neutropenic fever SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Nosebleed SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Pancytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Petechiae SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Petechiae abdomen SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Petechiae head, arms, neck, oral SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Petechiae thigh SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Thrombocytopenia, intermittent SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Elevated LDH SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Goiter, nodular SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hot flashes SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hyperphosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypermagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypomagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypomagnesium SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Uricemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Aching all over SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Bilateral upper pain - extremities SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Cellulitis, left arm SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Chest pressure SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Cramps right leg, right arm SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Cramps, muscle SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Diffused bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Left hip and leg pain, secondary to bone marrow aspiration SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Leg muscle soreness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Leg trembling on standing SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Pain, bilateral knee SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Pain, bilateral shoulder SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Pain, bone SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Pain, muscle SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Pain, back and shoulder SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Pain, neck SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Headache, sinus SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Insomnia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Light headed SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Neuropathy, bipedal SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Neuropathy, hands and feet SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Peripheral neuropathy, secondary to diabetes SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Night sweats SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Numbness, toe SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Dry throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Klebsiella pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pulmonary edema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Respiratory infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Short of breath SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Shortness of breath on exertion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Sinus congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Sinus pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Nasal congestion intermittent, secondary to allergies SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Sore throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Upper respiratory infection nasal allergies SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Allergic rhinitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Bleeding gums SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Conjunctival melanosis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Dental extraction SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Gum soreness SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Gum tenderness SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Itchy eyes SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Lip bleeding SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Loss of taste SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Malodor, secondary to right groin hematoma SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Mucositis SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Oral ulcer SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Right Ear Pressure SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Sinus drainage SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Staph infection right nostril SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Throat pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Worsening otitis media SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Dark urine SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Urinary tract infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Pain, low back SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Pain, upper extremities SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Teeth sensitivity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Tooth pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Anxiety SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Bad dreams SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Confusion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Mild confusion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Dizziness, fentanyl SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Dysphagia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Headache/migraine, intermittent right side SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Numbness/tingling in extremities SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Atelectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Mild fever SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pain, left flank SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pain, left upper quadrant SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Hemoglobin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Leukocytosis SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Palpitations SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Painful, red, swollen rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Elevated BUN SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Elevated PTT SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Elevated creatinine SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Cramps, neck SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Cramps, pedal muscle bilateral SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Dental abscesses SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Pain, knee SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Pain, left knee SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Pain, left great toe SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View