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 @ 2:16 AM
Ignite Modification Date:
2025-12-26 @ 12:46 AM
NCT ID:
NCT00069160
Description:
None
Frequency Threshold:
0
Time Frame:
4 years and 11 months
Study:
NCT00069160
Study Brief:
Tariquidar and Docetaxel to Treat Patients With Lung, Ovarian, Renal and Cervical Cancer
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Patients on Docetaxel on Days 1, 8 & Tariquidar on Day 8, 22 | Patients receive 40 mg/m\^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on days 8 and 22. From cycle 2 and onward 75 mg/m\^2 docetaxel was administered every 21 days in combination with a single 150 mg dose. | None | None | 6 | 23 | 23 | 23 | View |
| Patients on Docetaxel on Days 1, 8 & Tariquidar on Days 1, 22 | Patients receive 40 mg/m\^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on days 8 and 22. From cycle 2 and onward 75 mg/m\^2 docetaxel was administered every 21 days in combination with a single 150 mg dose. | None | None | 8 | 25 | 25 | 25 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| BLOOD/BONE MARROW:: Leukocytes (total WBC) | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA10/CTCv2.0 | View |
| CONSTITUTIONAL SYMPTOMS:: Fatigue (lethargy, malaise, asthenia) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA10/CTCv2.0 | View |
| CARDIOVASCULAR (GENERAL):: Hypotension | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA10/CTCv2.0 | View |
| CARDIOVASCULAR (GENERAL):: Thrombosis/embolism | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA10/CTCv2.0 | View |
| GASTROINTESTINAL:: Anorexia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA10/CTCv2.0 | View |
| HEMORRHAGE:: Rectal bleeding/hematochezia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA10/CTCv2.0 | View |
| HEPATIC:: Alkaline phosphatase | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA10/CTCv2.0 | View |
| HEPATIC:: SGOT (AST) (serum glutamic oxaloacetic transaminase) | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA10/CTCv2.0 | View |
| HEPATIC:: SGPT (ALT) (serum glutamic pyruvic transaminase) | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA10/CTCv2.0 | View |
| INFECTION/FEBRILE NEUTROPENIA:: Febrile neutropenia (fever of unknown origin without clinically or m | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA10/CTCv2.0 | View |
| METABOLIC/LABORATORY:: Hyponatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA10/CTCv2.0 | View |
| MUSCULOSKELETAL:: Muscle weakness (not due to neuropathy) | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA10/CTCv2.0 | View |
| NEUROLOGY:: Depressed level of consciousness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA10/CTCv2.0 | View |
| NEUROLOGY:: Mood alteration-anxiety, agitation | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA10/CTCv2.0 | View |
| PULMONARY:: Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA10/CTCv2.0 | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA10/CTCv2.0 | View |
| Pneumothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA10/CTCv2.0 | View |
| Urinary frequency/urgency | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA10/CTCv2.0 | View |
| CONSTITUTIONAL SYMPTOMS:: | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA10/CTCv2.0 | View |
| CONSTITUTIONAL SYMPTOMS:: Rigors, chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA10/CTCv2.0 | View |
| DERMATOLOGY/SKIN:: Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA10/CTCv2.0 | View |
| MUSCULOSKELETAL:: Musculoskeletal-Other (Specify,musculoskeletal-lethargic) | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA10/CTCv2.0 | View |
| NEUROLOGY:: Dizziness/lightheadedness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA10/CTCv2.0 | View |
| PULMONARY:: Dyspnea (shortness of breath) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA10/CTCv2.0 | View |
| PULMONARY:: Pulmonary-Other (Specify,clinical deterioration) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA10/CTCv2.0 | View |
| BLOOD/BONE MARROW:: Neutrophils/granulocytes (ANC/AGC) | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA10/CTCv2.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| AUDITORY/HEARING:: Middle ear/hearing | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA10/CTCv2.0 | View |
| BLOOD/BONE MARROW:: Hemoglobin | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA10/CTCv2.0 | View |
| BLOOD/BONE MARROW:: Leukocytes (total WBC) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA10/CTCv2.0 | View |
| BLOOD/BONE MARROW:: Lymphopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA10/CTCv2.0 | View |
| BLOOD/BONE MARROW:: Neutrophils/granulocytes (ANC/AGC) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA10/CTCv2.0 | View |
| BLOOD/BONE MARROW:: Platelets | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA10/CTCv2.0 | View |
| BLOOD/BONE MARROW:: Transfusion: pRBCs | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA10/CTCv2.0 | View |
| CARDIOVASCULAR (ARRHYTHMIA):: Sinus tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA10/CTCv2.0 | View |
| CARDIOVASCULAR (GENERAL):: Edema | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA10/CTCv2.0 | View |
| CARDIOVASCULAR (GENERAL):: Hypertension | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA10/CTCv2.0 | View |
| CARDIOVASCULAR (GENERAL):: Hypotension | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA10/CTCv2.0 | View |
| CARDIOVASCULAR (GENERAL):: Phlebitis (superficial) | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA10/CTCv2.0 | View |
| CARDIOVASCULAR (GENERAL):: Thrombosis/embolism | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA10/CTCv2.0 | View |
| COAGULATION:: Partial thromboplastin time (PTT) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA10/CTCv2.0 | View |
| COAGULATION:: Prothrombin time (PT) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA10/CTCv2.0 | View |
| CONSTITUTIONAL SYMPTOMS:: Fatigue (lethargy, malaise, asthenia) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA10/CTCv2.0 | View |
| CONSTITUTIONAL SYMPTOMS:: Fever (in the absence of neutropenia, where neutropenia is defined as AGC< | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA10/CTCv2.0 | View |
| CONSTITUTIONAL SYMPTOMS:: Rigors, chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA10/CTCv2.0 | View |
| CONSTITUTIONAL SYMPTOMS:: Weight loss | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA10/CTCv2.0 | View |
| DERMATOLOGY/SKIN:: Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA10/CTCv2.0 | View |
| DERMATOLOGY/SKIN:: Dermatology/Skin-Other (Specify,_____) | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA10/CTCv2.0 | View |
| DERMATOLOGY/SKIN:: Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA10/CTCv2.0 | View |
| DERMATOLOGY/SKIN:: Erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis) | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA10/CTCv2.0 | View |
| DERMATOLOGY/SKIN:: Flushing | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA10/CTCv2.0 | View |
| DERMATOLOGY/SKIN:: Hand-foot skin reaction | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA10/CTCv2.0 | View |
| DERMATOLOGY/SKIN:: Injection site reaction | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA10/CTCv2.0 | View |
| DERMATOLOGY/SKIN:: Nail changes | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA10/CTCv2.0 | View |
| DERMATOLOGY/SKIN:: Radiation dermatitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA10/CTCv2.0 | View |
| DERMATOLOGY/SKIN:: Rash/desquamation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA10/CTCv2.0 | View |
| GASTROINTESTINAL:: Anorexia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA10/CTCv2.0 | View |
| GASTROINTESTINAL:: Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA10/CTCv2.0 | View |
| GASTROINTESTINAL:: Dehydration | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA10/CTCv2.0 | View |
| GASTROINTESTINAL:: Diarrhea patients without colostomy | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA10/CTCv2.0 | View |
| GASTROINTESTINAL:: Dyspepsia/heartburn | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA10/CTCv2.0 | View |
| GASTROINTESTINAL:: Dysphagia, esophagitis, odynophagia (painful swallowing) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA10/CTCv2.0 | View |
| GASTROINTESTINAL:: Flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA10/CTCv2.0 | View |
| GASTROINTESTINAL:: Gastrointestinal-Other (Specify,_____) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA10/CTCv2.0 | View |
| GASTROINTESTINAL:: Mouth dryness | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA10/CTCv2.0 | View |
| GASTROINTESTINAL:: Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA10/CTCv2.0 | View |
| GASTROINTESTINAL:: Stomatitis/pharyngitis (oral/pharyngeal mucositis) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA10/CTCv2.0 | View |
| GASTROINTESTINAL:: Taste disturbance (dysgeusia) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA10/CTCv2.0 | View |
| GASTROINTESTINAL:: Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA10/CTCv2.0 | View |
| HEMORRHAGE:: Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA10/CTCv2.0 | View |
| HEPATIC:: Alkaline phosphatase | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA10/CTCv2.0 | View |
| HEPATIC:: Bilirubin | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA10/CTCv2.0 | View |
| HEPATIC:: Hypoalbuminemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA10/CTCv2.0 | View |
| HEPATIC:: SGOT (AST) (serum glutamic oxaloacetic transaminase) | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA10/CTCv2.0 | View |
| HEPATIC:: SGPT (ALT) (serum glutamic pyruvic transaminase) | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA10/CTCv2.0 | View |
| INFECTION/FEBRILE NEUTROPENIA:: Catheter-related infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA10/CTCv2.0 | View |
| INFECTION/FEBRILE NEUTROPENIA:: | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA10/CTCv2.0 | View |
| INFECTION/FEBRILE NEUTROPENIA:: | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA10/CTCv2.0 | View |
| INFECTION/FEBRILE NEUTROPENIA:: Infection without neutropenia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA10/CTCv2.0 | View |
| METABOLIC/LABORATORY:: Bicarbonate | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA10/CTCv2.0 | View |
| METABOLIC/LABORATORY:: CPK (creatine phosphokinase) | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA10/CTCv2.0 | View |
| METABOLIC/LABORATORY:: Hypercalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA10/CTCv2.0 | View |
| METABOLIC/LABORATORY:: Hyperglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA10/CTCv2.0 | View |
| METABOLIC/LABORATORY:: Hyperkalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA10/CTCv2.0 | View |
| METABOLIC/LABORATORY:: Hypermagnesemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA10/CTCv2.0 | View |
| METABOLIC/LABORATORY:: Hypernatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA10/CTCv2.0 | View |
| METABOLIC/LABORATORY:: Hypocalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA10/CTCv2.0 | View |
| METABOLIC/LABORATORY:: Hypoglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA10/CTCv2.0 | View |
| METABOLIC/LABORATORY:: Hypomagnesemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA10/CTCv2.0 | View |
| METABOLIC/LABORATORY:: Hyponatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA10/CTCv2.0 | View |
| METABOLIC/LABORATORY:: Hypophosphatemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA10/CTCv2.0 | View |
| MUSCULOSKELETAL:: Muscle weakness (not due to neuropathy) | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA10/CTCv2.0 | View |
| NEUROLOGY:: Ataxia (incoordination) | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA10/CTCv2.0 | View |
| NEUROLOGY:: Confusion | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA10/CTCv2.0 | View |
| NEUROLOGY:: Depressed level of consciousness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA10/CTCv2.0 | View |
| NEUROLOGY:: Dizziness/lightheadedness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA10/CTCv2.0 | View |
| NEUROLOGY:: Extrapyramidal/involuntary movement/restlessness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA10/CTCv2.0 | View |
| NEUROLOGY:: Insomnia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA10/CTCv2.0 | View |
| NEUROLOGY:: Mood alteration-depression | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA10/CTCv2.0 | View |
| METABOLIC/LABORATORY:: Hypokalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA10/CTCv2.0 | View |
| NEUROLOGY:: Neuropathy-sensory | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA10/CTCv2.0 | View |
| NEUROLOGY:: Seizure(s) | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA10/CTCv2.0 | View |
| NEUROLOGY:: Syncope (fainting | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA10/CTCv2.0 | View |
| NEUROLOGY:: Vertigo | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA10/CTCv2.0 | View |
| OCULAR/VISUAL:: Conjunctivitis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA10/CTCv2.0 | View |
| OCULAR/VISUAL:: Dry eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA10/CTCv2.0 | View |
| OCULAR/VISUAL:: Tearing (watery eyes) | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA10/CTCv2.0 | View |
| PAIN:: Abdominal pain or cramping | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA10/CTCv2.0 | View |
| PAIN:: Arthralgia (joint pain) | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA10/CTCv2.0 | View |
| PAIN:: Bone pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA10/CTCv2.0 | View |
| PAIN:: Chest pain (non-cardiac and non-pleuritic) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA10/CTCv2.0 | View |
| PAIN:: Myalgia (muscle pain) | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA10/CTCv2.0 | View |
| PAIN:: Neuropathic pain (e.g., jaw pain, neurologic pain, phantom limb pain, post-infectious neuralg | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA10/CTCv2.0 | View |
| PAIN:: Pain-Other (Specify,___) | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA10/CTCv2.0 | View |
| PULMONARY:: Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA10/CTCv2.0 | View |
| PULMONARY:: Dyspnea (shortness of breath) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA10/CTCv2.0 | View |
| PULMONARY:: Pleural effusion (non-malignant) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA10/CTCv2.0 | View |
| PULMONARY:: Pulmonary-Other (Specify,___) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA10/CTCv2.0 | View |
| PULMONARY:: Voice changes/stridor/larynx (e.g., hoarseness, loss of voice, laryngitis) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA10/CTCv2.0 | View |
| RENAL/GENITOURINARY:: Creatinine | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA10/CTCv2.0 | View |
| PULMONARY:: Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA10/CTCv2.0 | View |
| RENAL/GENITOURINARY:: Urinary frequency/urgency | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA10/CTCv2.0 | View |
| ALLERGY/IMMUNOLOGY:: Allergic reaction/hypersensitivity (including drug fever) | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA10/CTCv2.0 | View |
| ALLERGY/IMMUNOLOGY:: Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA10/CTCv2.0 | View |
| PAIN:: Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA10/CTCv2.0 | View |
| ALLERGY/IMMUNOLOGY:: Allergy-Other (Specify,_____) | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA10/CTCv2.0 | View |
| BLOOD/BONE MARROW:: Hemoglobin | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA10/CTCv2.0 | View |
| CARDIOVASCULAR (ARRHYTHMIA):: Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA10/CTCv2.0 | View |
| DERMATOLOGY/SKIN:: Bruising (in absence of grade 3 or 4 thrombocytopenia) | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA10/CTCv2.0 | View |
| DERMATOLOGY/SKIN:: Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA10/CTCv2.0 | View |
| DERMATOLOGY/SKIN:: Wound-non-infectious | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA10/CTCv2.0 | View |
| GASTROINTESTINAL:: Mucositis due to radiation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA10/CTCv2.0 | View |
| GASTROINTESTINAL:: Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA10/CTCv2.0 | View |
| HEMORRHAGE:: CNS hemorrhage/bleeding | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA10/CTCv2.0 | View |
| HEMORRHAGE:: Hematuria (in the absence of vaginal bleeding) | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA10/CTCv2.0 | View |
| HEMORRHAGE:: Rectal bleeding/hematochezia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA10/CTCv2.0 | View |
| INFECTION/FEBRILE NEUTROPENIA:: Infection/Febrile Neutropenia-Other (Specify,____) | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA10/CTCv2.0 | View |
| METABOLIC/LABORATORY:: Hyperuricemia | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA10/CTCv2.0 | View |
| NEUROLOGY:: Mood alteration-anxiety, agitation | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA10/CTCv2.0 | View |
| OCULAR/VISUAL:: Ocular/Visual-Other (Specify,___) | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA10/CTCv2.0 | View |
| OCULAR/VISUAL:: Vision-blurred vision | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA10/CTCv2.0 | View |
| PAIN:: Earache (otalgia) | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA10/CTCv2.0 | View |
| PAIN:: Pelvic pain | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA10/CTCv2.0 | View |
| RENAL/GENITOURINARY:: Dysuria (painful urination) | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA10/CTCv2.0 | View |
| RENAL/GENITOURINARY:: Urinary retention | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA10/CTCv2.0 | View |