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
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Phase 1b Cohort I: Cisplatin Eligible - Pembrolizumab 200 mg | Cisplatin-eligible subjects were received pembrolizumab at starting dose of 200mg (dose level 0) in combination with gemcitabine and cisplatin. Once the MTD is established, this portion of the study will close and the phase II will open to cohorts I and II at the recommended phase II dose (RP2D). Pembrolizumab: In this dose-finding cohort, pembrolizumab (MK-3475) were administered (cisplatin-eligible patients only) at starting dose 200mg IV every 21 days for 4 cycles to determine RP2D. Once MTD is established in phase Ib, pembrolizumab will be administered on phase II cohorts I and II at RP2D every 21 days for 5 cycles. Gemcitabine: For cisplatin-eligible patients on phase Ib, gemcitabine 1000mg/m2 IV, D1 and D8 every 21 days for 4 cycles. Cisplatin: For cisplatin-eligible patients, cisplatin 70mg/m2 IV will be administered D1 every 21 days for 4 cycles. | 1 | None | 1 | 6 | 6 | 6 | View |
| Phase II Cohort I: Cisplatin Eligible- Pembrolizumab 200 mg | Cisplatin-eligible subjects receive gemcitabine/cisplatin every 21 days, repeated for 4 cycles. (Subjects with Ccr of 50-59 mL/min must follow split dosing of cisplatin over two days) . Pembrolizumab at RP2D is given every 21 days for 5 doses starting C1D8. Note: the last dose of pembrolizumab falls on what would be day 8 of a 5th 'chemo' cycle, however gemcitabine/cisplatin is NOT GIVEN. Subjects will then have consolidative surgery to remove their primary tumor within 2-7 weeks after their last dose of neoadjuvant therapy. Pembrolizumab: Once MTD is established in phase Ib, pembrolizumab will be administered on phase II cohorts I and II at RP2D every 21 days for 5 cycles. Gemcitabine: For cisplatin-eligible patients on phase II cohort 1, gemcitabine 1000mg/m2 IV, D1 and D8 every 21 days for 4 cycles. Cisplatin: For cisplatin-eligible patients, cisplatin 70mg/m2 IV will be administered D1 every 21 days for 4 cycles. | 11 | None | 17 | 37 | 37 | 37 | View |
| Phase II Cohort II: Cisplatin Ineligible -Pembrolizumab 200 mg | Cisplatin ineligible (receive treatment in Phase II only): Cisplatin ineligible subjects receive gemcitabine every week (weekly) for three consecutive weeks, repeated every 28 days for 3 cycles. Pembrolizumab is given every 3 weeks for 5 doses starting with Cycle 1 Day 8 (C1D8). NOTE: due to the timing of gemcitabine cycles every 4 weeks, and every three week dosing of pembrolizumab, there are two doses of pembrolizumab given during cycle 2: days 1 and 22. Additionally, the last dose of pembrolizumab falls on what would be day 8 of a 4th 'chemo' cycle; however gemcitabine is NOT GIVEN. | 16 | None | 17 | 38 | 38 | 38 | View |
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| DYSPNEA | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAEv4 | View |
| HEMATURIA | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAEv4 | View |
| JEJUNAL FISTULA | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEv4 | View |
| KIDNEY INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAEv4 | View |
| LUNG INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAEv4 | View |
| MOBITZ TYPE I | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAEv4 | View |
| RASH MACULO-PAPULAR | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAEv4 | View |
| RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - OTHER, SPECIFY | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAEv4 | View |
| SINUS TACHYCARDIA | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAEv4 | View |
| SKIN AND SUBCUTANEOUS TISSUE DISORDERS - OTHER, SPECIFY | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAEv4 | View |
| SYNCOPE | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAEv4 | View |
| URINARY TRACT INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAEv4 | View |
| URINARY TRACT OBSTRUCTION | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAEv4 | View |
| ABDOMINAL PAIN | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEv4 | View |
| ALANINE AMINOTRANSFERASE INCREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAEv4 | View |
| ALKALINE PHOSPHATASE INCREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAEv4 | View |
| ASPARTATE AMINOTRANSFERASE INCREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAEv4 | View |
| CARDIAC DISORDERS - OTHER, SPECIFY | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAEv4 | View |
| COLITIS | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEv4 | View |
| CONSTIPATION | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEv4 | View |
| DYSPHASIA | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAEv4 | View |
| GENERALIZED MUSCLE WEAKNESS | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAEv4 | View |
| HEART FAILURE | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAEv4 | View |
| HYPERTHYROIDISM | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCAEv4 | View |
| HYPOTENSION | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAEv4 | View |
| INFECTIONS AND INFESTATIONS - OTHER, SPECIFY | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAEv4 | View |
| MUSCLE WEAKNESS LOWER LIMB | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAEv4 | View |
| PAIN | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAEv4 | View |
| PLATELET COUNT DECREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAEv4 | View |
| PNEUMONITIS | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAEv4 | View |
| SOFT TISSUE INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAEv4 | View |
| ACIDOSIS | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAEv4 | View |
| ACUTE KIDNEY INJURY | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAEv4 | View |
| FEVER | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAEv4 | View |
| HYPONATREMIA | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAEv4 | View |
| SEPSIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAEv4 | View |
| THROMBOEMBOLIC EVENT | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAEv4 | View |
| ACUTE CORONARY SYNDROME | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAEv4 | View |
| ANEMIA | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAEv4 | View |
| APPENDICITIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAEv4 | View |
| CONFUSION | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAEv4 | View |
| CREATININE INCREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAEv4 | View |
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| ABDOMINAL PAIN | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEv4 | View |
| ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAEv4 | View |
| ACUTE KIDNEY INJURY | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAEv4 | View |
| ADRENAL INSUFFICIENCY | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCAEv4 | View |
| ALANINE AMINOTRANSFERASE INCREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAEv4 | View |
| ALLERGIC RHINITIS | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAEv4 | View |
| ALOPECIA | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAEv4 | View |
| ANEMIA | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAEv4 | View |
| ANOREXIA | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAEv4 | View |
| ANXIETY | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAEv4 | View |
| ARTHRALGIA | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAEv4 | View |
| ASPARTATE AMINOTRANSFERASE INCREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAEv4 | View |
| BACK PAIN | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAEv4 | View |
| BLOATING | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEv4 | View |
| BLURRED VISION | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAEv4 | View |
| BRUISING | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAEv4 | View |
| CONSTIPATION | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEv4 | View |
| COUGH | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAEv4 | View |
| CREATININE INCREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAEv4 | View |
| DEHYDRATION | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAEv4 | View |
| DEPRESSION | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAEv4 | View |
| DIARRHEA | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEv4 | View |
| DIZZINESS | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAEv4 | View |
| DYSGEUSIA | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAEv4 | View |
| DYSPNEA | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAEv4 | View |
| EDEMA LIMBS | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAEv4 | View |
| FATIGUE | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAEv4 | View |
| FEVER | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAEv4 | View |
| FLANK PAIN | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAEv4 | View |
| GASTROINTESTINAL DISORDERS - OTHER, SPECIFY | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEv4 | View |
| GENERALIZED MUSCLE WEAKNESS | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAEv4 | View |
| HEARING IMPAIRED | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAEv4 | View |
| HYPERGLYCEMIA | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAEv4 | View |
| HYPERTENSION | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAEv4 | View |
| HYPOALBUMINEMIA | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAEv4 | View |
| HYPOCALCEMIA | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAEv4 | View |
| HYPOGLYCEMIA | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAEv4 | View |
| HYPOMAGNESEMIA | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAEv4 | View |
| HYPONATREMIA | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAEv4 | View |
| HYPOTENSION | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAEv4 | View |
| INSOMNIA | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAEv4 | View |
| LYMPHOCYTE COUNT DECREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAEv4 | View |
| METABOLISM AND NUTRITION DISORDERS - OTHER, SPECIFY | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAEv4 | View |
| NAUSEA | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEv4 | View |
| NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) - OTHER, SPECIFY | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAEv4 | View |
| NEUTROPHIL COUNT DECREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAEv4 | View |
| PAIN | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAEv4 | View |
| PALMAR-PLANTAR ERYTHRODYSESTHESIA SYNDROME | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAEv4 | View |
| PAPULOPUSTULAR RASH | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAEv4 | View |
| PERIPHERAL SENSORY NEUROPATHY | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAEv4 | View |
| PLATELET COUNT DECREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAEv4 | View |
| PRODUCTIVE COUGH | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAEv4 | View |
| PRURITUS | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAEv4 | View |
| RASH MACULO-PAPULAR | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAEv4 | View |
| RENAL AND URINARY DISORDERS - OTHER, SPECIFY | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAEv4 | View |
| SINUS TACHYCARDIA | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAEv4 | View |
| SKIN AND SUBCUTANEOUS TISSUE DISORDERS - OTHER, SPECIFY | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAEv4 | View |
| SKIN INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAEv4 | View |
| SMALL INTESTINAL OBSTRUCTION | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEv4 | View |
| SORE THROAT | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAEv4 | View |
| TINNITUS | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAEv4 | View |
| TREMOR | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAEv4 | View |
| URINARY FREQUENCY | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAEv4 | View |
| URINARY RETENTION | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAEv4 | View |
| URINARY TRACT INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAEv4 | View |
| URINARY TRACT PAIN | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAEv4 | View |
| VOMITING | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEv4 | View |
| WEIGHT LOSS | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAEv4 | View |
| WHITE BLOOD CELL DECREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAEv4 | View |
| ABDOMINAL DISTENSION | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEv4 | View |
| ALKALINE PHOSPHATASE INCREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAEv4 | View |
| BLADDER INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAEv4 | View |
| BLADDER SPASM | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAEv4 | View |
| BLOOD AND LYMPHATIC SYSTEM DISORDERS - OTHER, SPECIFY | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAEv4 | View |
| BLOOD BILIRUBIN INCREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAEv4 | View |
| BONE PAIN | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAEv4 | View |
| BRONCHIAL INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAEv4 | View |
| BUTTOCK PAIN | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAEv4 | View |
| CARDIAC ARREST | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAEv4 | View |
| CATARACT | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAEv4 | View |
| CHEST WALL PAIN | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAEv4 | View |
| CHOLESTEROL HIGH | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAEv4 | View |
| CHRONIC KIDNEY DISEASE | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAEv4 | View |
| COLITIS | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEv4 | View |
| DRY EYE | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAEv4 | View |
| DRY MOUTH | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEv4 | View |
| DRY SKIN | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAEv4 | View |
| DYSPEPSIA | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEv4 | View |
| DYSPHAGIA | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEv4 | View |
| EDEMA FACE | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAEv4 | View |
| ENTEROCOLITIS | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEv4 | View |
| EPISTAXIS | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAEv4 | View |
| EYE DISORDERS - OTHER, SPECIFY | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAEv4 | View |
| EYE PAIN | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAEv4 | View |
| FEBRILE NEUTROPENIA | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAEv4 | View |
| FLU LIKE SYMPTOMS | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAEv4 | View |
| FLUSHING | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAEv4 | View |
| GAIT DISTURBANCE | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAEv4 | View |
| GASTRITIS | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEv4 | View |
| GASTROESOPHAGEAL REFLUX DISEASE | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEv4 | View |
| GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS - OTHER, SPECIFY | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAEv4 | View |
| GINGIVAL PAIN | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEv4 | View |
| GLAUCOMA | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAEv4 | View |
| HEADACHE | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAEv4 | View |
| HEMATOMA | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAEv4 | View |
| HEMATURIA | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAEv4 | View |
| HICCUPS | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAEv4 | View |
| HOARSENESS | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAEv4 | View |
| HOT FLASHES | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAEv4 | View |
| HYPERCALCEMIA | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAEv4 | View |
| HYPERKALEMIA | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAEv4 | View |
| HYPERTHYROIDISM | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCAEv4 | View |
| HYPOKALEMIA | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAEv4 | View |
| HYPOPHOSPHATEMIA | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAEv4 | View |
| HYPOTHYROIDISM | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCAEv4 | View |
| ILEAL OBSTRUCTION | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEv4 | View |
| INFECTIONS AND INFESTATIONS - OTHER, SPECIFY | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAEv4 | View |
| INFUSION RELATED REACTION | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAEv4 | View |
| INFUSION SITE EXTRAVASATION | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAEv4 | View |
| INJECTION SITE REACTION | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAEv4 | View |
| INJURY TO SUPERIOR VENA CAVA | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAEv4 | View |
| LOCALIZED EDEMA | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAEv4 | View |
| MUCOSITIS ORAL | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEv4 | View |
| MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDER - OTHER, SPECIFY | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAEv4 | View |
| MYALGIA | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAEv4 | View |
| NASAL CONGESTION | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAEv4 | View |
| PAIN IN EXTREMITY | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAEv4 | View |
| PAIN OF SKIN | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAEv4 | View |
| PANCREATIC ANASTOMOTIC LEAK | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAEv4 | View |
| PELVIC PAIN | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAEv4 | View |
| PENILE PAIN | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAEv4 | View |
| PHLEBITIS | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAEv4 | View |
| PNEUMONITIS | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAEv4 | View |
| POSTNASAL DRIP | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAEv4 | View |
| PROTEINURIA | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAEv4 | View |
| PURPURA | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAEv4 | View |
| RASH ACNEIFORM | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAEv4 | View |
| RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - OTHER, SPECIFY | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAEv4 | View |
| RHINITIS INFECTIVE | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAEv4 | View |
| SCROTAL PAIN | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAEv4 | View |
| SINUS BRADYCARDIA | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAEv4 | View |
| SINUS DISORDER | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAEv4 | View |
| SNEEZING | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAEv4 | View |
| SUPERFICIAL THROMBOPHLEBITIS | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAEv4 | View |
| THROMBOEMBOLIC EVENT | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAEv4 | View |
| THROMBOTIC THROMBOCYTOPENIC PURPURA | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAEv4 | View |
| TOOTH INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAEv4 | View |
| UPPER RESPIRATORY INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAEv4 | View |
| URINARY INCONTINENCE | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAEv4 | View |
| URINARY TRACT OBSTRUCTION | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAEv4 | View |
| URINARY URGENCY | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAEv4 | View |
| URTICARIA | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAEv4 | View |
| VAGINAL DRYNESS | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAEv4 | View |
| VASCULAR DISORDERS - OTHER, SPECIFY | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAEv4 | View |
| WATERING EYES | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAEv4 | View |
| WEIGHT GAIN | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAEv4 | View |
| AKATHISIA | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAEv4 | View |
| ASCITES | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEv4 | View |
| ATRIAL FIBRILLATION | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAEv4 | View |
| ATRIAL FLUTTER | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAEv4 | View |
| CARDIAC DISORDERS - OTHER, SPECIFY | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAEv4 | View |
| CHILLS | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAEv4 | View |
| CONFUSION | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAEv4 | View |
| CYSTITIS NONINFECTIVE | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAEv4 | View |
| EAR AND LABYRINTH DISORDERS - OTHER, SPECIFY | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAEv4 | View |
| ERYTHEMA MULTIFORME | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAEv4 | View |
| FALL | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAEv4 | View |
| HEART FAILURE | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAEv4 | View |
| HEPATIC FAILURE | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAEv4 | View |
| HYPERMAGNESEMIA | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAEv4 | View |
| HYPERURICEMIA | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAEv4 | View |
| LEUKOCYTOSIS | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAEv4 | View |
| LUNG INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAEv4 | View |
| LYMPHEDEMA | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAEv4 | View |
| MALAISE | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAEv4 | View |
| MUCOSAL INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAEv4 | View |
| MUSCLE WEAKNESS LOWER LIMB | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAEv4 | View |
| NAIL DISCOLORATION | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAEv4 | View |
| NAIL INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAEv4 | View |
| NECK PAIN | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAEv4 | View |
| NERVOUS SYSTEM DISORDERS - OTHER, SPECIFY | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAEv4 | View |
| NON-CARDIAC CHEST PAIN | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAEv4 | View |
| ORAL PAIN | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEv4 | View |
| PERIPHERAL MOTOR NEUROPATHY | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAEv4 | View |
| PHARYNGEAL MUCOSITIS | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAEv4 | View |
| PLEURAL EFFUSION | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAEv4 | View |
| PULMONARY EDEMA | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAEv4 | View |
| SCROTAL INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAEv4 | View |
| SEIZURE | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAEv4 | View |
| SOFT TISSUE INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAEv4 | View |
| VAGINAL PAIN | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAEv4 | View |
| VENTRICULAR TACHYCARDIA | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAEv4 | View |
| VERTIGO | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAEv4 | View |
| WHEEZING | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAEv4 | View |