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 @ 12:30 PM
Ignite Modification Date:
2025-12-25 @ 12:09 PM
NCT ID:
NCT02408861
Description:
All adverse events, irrespective of their attribution have been included.
Frequency Threshold:
5
Time Frame:
Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event.
Study:
NCT02408861
Study Brief:
Nivolumab and Ipilimumab in Treating Patients With HIV Associated Relapsed or Refractory Classical Hodgkin Lymphoma or Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Dose De-escalation Nivolumab 3mg/kg (Stratum 1) | Nivolumab 3 mg/kg body weight (Dose level 1) Stratum 1: Participants with CD4+ count \> 200/mm3. Start with a full dose of nivolumab 3 mg/kg (dose level 1) and one dose de-escalation is allowed; after evaluating dosing for single agent nivolumab then participants will be treated with 240 mg of nivolumab. No intra-participant dose escalations will be allowed. The safety evaluation period is 6 weeks at a given dose level. | 0 | None | 3 | 6 | 4 | 6 | View |
| Dose De-escalation Nivolumab 3 mg/kg (Stratum 2) | Nivolumab 3 mg/kg body weight (Dose level 1) Stratum 2 : Participants with CD4+ count between 100-200/mm3. Enrollment Stratum 2 will begin after Stratum 1 has completed. Stratum 2 dosing will begin at the single-agent therapy MTD for Stratum 1 (dose level 1 or -1). Stratum 2 will not be allowed to escalate beyond the MTD for Stratum 1. Only 1 dose de-escalation will be allowed. | 3 | None | 6 | 9 | 7 | 9 | View |
| Dose De-escalation Nivolumab 240mg and Ipilimumab 1 mg/kg (Stratum 1) | Nivolumab 240mg and Ipilimumab 1 mg/kg (Dose level 2); Stratum 1: CD4 count \>200 per mm3; No intra-participant dose escalations will be allowed. The safety evaluation period is 6 weeks at a given dose level. | 1 | None | 3 | 7 | 6 | 7 | View |
| Dose De-escalation Nivolumab 240 mg and Ipilimumab 1mg/kg (Stratum 2) | Nivolumab 240 mg and Ipilimumab 1mg/kg (Dose level 2); Stratum 2: participants with lymphocyte T CD4+ count between 100-200/mm3; Participants will be treated with 240 mg of nivolumab and 1 mg/kg of ipilimumab will be added to evaluate combination therapy (dose level 2) with one dose de- escalation allowed. No intra-participant dose escalations will be allowed. The safety evaluation period is 6 weeks at a given dose level. | 2 | None | 2 | 4 | 3 | 4 | View |
| Dose Expansion Nivolumab 240 mg q2w in Solid Tumors | Participants with incurable solid tumors will be treated at single agent nivolumab 240 mg every 2 weeks. Only those histologies that are not known to respond to single agent nivolumab will be excluded (i.e., pancreas, prostate, MSS colorectal cancer, unless results from another clinical trial showing non-response in another tumor type become available in the future). Up to 24 participants will be enrolled. | 5 | None | 9 | 24 | 16 | 24 | View |
| Dose Expansion Nivolumab 240 mg and Ipilimumab 1 mg/kg | The combination therapy MTD will be studied in a dose expansion cohort (up to 12 participants) limited to only participants with Kaposi sarcoma, lung cancer, and anal cancer. | 1 | None | 5 | 20 | 15 | 20 | View |
| Nivolumab 240 mg q2w in Classical Hodgkin Lymphoma | Single agent Nivolumab therapy will be administered in participants with classical Hodgkin's Lymphoma with a fixed dose of 240 mg q 2 week. | 0 | None | 2 | 9 | 6 | 9 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| CARDIAC ARREST | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (Unspecified) | View |
| CARDIAC DISORDERS - OTHER, SPECIFY | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (Unspecified) | View |
| PERICARDIAL TAMPONADE | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (Unspecified) | View |
| ADRENAL INSUFFICIENCY | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCAE (Unspecified) | View |
| HYPOTHYROIDISM | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCAE (Unspecified) | View |
| ABDOMINAL PAIN | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| ASCITES | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| COLITIS | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| CONSTIPATION | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| DIARRHEA | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| ORAL HEMORRHAGE | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| DEATH NOS | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (Unspecified) | View |
| DISEASE PROGRESSION | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (Unspecified) | View |
| HEPATIC FAILURE | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE (Unspecified) | View |
| INFECTIONS AND INFESTATIONS - OTHER, SPECIFY | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (Unspecified) | View |
| INFECTIONS AND INFESTATIONS - OTHER, SPECIFY | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (Unspecified) | View |
| LUNG INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (Unspecified) | View |
| RASH PUSTULAR | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (Unspecified) | View |
| SEPSIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (Unspecified) | View |
| SKIN INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (Unspecified) | View |
| UPPER RESPIRATORY INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (Unspecified) | View |
| URINARY TRACT INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (Unspecified) | View |
| FRACTURE | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (Unspecified) | View |
| INJURY, POISONING AND PROCEDURAL COMPLICATIONS - OTHER, SPECIFY | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (Unspecified) | View |
| ALANINE AMINOTRANSFERASE INCREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (Unspecified) | View |
| ASPARTATE AMINOTRANSFERASE INCREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (Unspecified) | View |
| HYPERGLYCEMIA | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (Unspecified) | View |
| HYPONATREMIA | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (Unspecified) | View |
| PAIN IN EXTREMITY | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | View |
| NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) - OTHER, SPECIFY | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (Unspecified) | View |
| NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) - OTHER, SPECIFY | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (Unspecified) | View |
| ENCEPHALOPATHY | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (Unspecified) | View |
| ACUTE KIDNEY INJURY | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (Unspecified) | View |
| ASPIRATION | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | View |
| ATELECTASIS | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | View |
| DYSPNEA | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | View |
| PLEURAL EFFUSION | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | View |
| RESPIRATORY FAILURE | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | View |
| SKIN AND SUBCUTANEOUS TISSUE DISORDERS - OTHER, SPECIFY | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | View |
| HYPOTENSION | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (Unspecified) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| MALAISE | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (Unspecified) | View |
| HEADACHE | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (Unspecified) | View |
| LETHARGY | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (Unspecified) | View |
| PARESTHESIA | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (Unspecified) | View |
| PERIPHERAL SENSORY NEUROPATHY | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (Unspecified) | View |
| PRESYNCOPE | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (Unspecified) | View |
| SYNCOPE | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (Unspecified) | View |
| VASOVAGAL REACTION | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (Unspecified) | View |
| ANXIETY | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (Unspecified) | View |
| INSOMNIA | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (Unspecified) | View |
| PSYCHIATRIC DISORDERS - OTHER, SPECIFY | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (Unspecified) | View |
| CHRONIC KIDNEY DISEASE | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (Unspecified) | View |
| DYSURIA | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (Unspecified) | View |
| RENAL AND URINARY DISORDERS - OTHER, SPECIFY | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (Unspecified) | View |
| URINARY FREQUENCY | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (Unspecified) | View |
| URINARY RETENTION | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (Unspecified) | View |
| URINARY URGENCY | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (Unspecified) | View |
| GENITAL EDEMA | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE (Unspecified) | View |
| VAGINAL HEMORRHAGE | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE (Unspecified) | View |
| BRONCHIAL OBSTRUCTION | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | View |
| COUGH | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | View |
| DYSPNEA | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | View |
| EPISTAXIS | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | View |
| HOARSENESS | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | View |
| NASAL CONGESTION | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | View |
| PLEURAL EFFUSION | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | View |
| PNEUMONITIS | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | View |
| POSTNASAL DRIP | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | View |
| PRODUCTIVE COUGH | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | View |
| RHINORRHEA | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | View |
| SNEEZING | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | View |
| SORE THROAT | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | View |
| ALOPECIA | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | View |
| DRY SKIN | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | View |
| HYPERHIDROSIS | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | View |
| HYPERTRICHOSIS | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | View |
| PRURITUS | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | View |
| RASH ACNEIFORM | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | View |
| RASH MACULO-PAPULAR | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | View |
| SKIN AND SUBCUTANEOUS TISSUE DISORDERS - OTHER, SPECIFY | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | View |
| SKIN AND SUBCUTANEOUS TISSUE DISORDERS - OTHER, SPECIFY | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | View |
| SKIN AND SUBCUTANEOUS TISSUE DISORDERS - OTHER, SPECIFY | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | View |
| SURGICAL AND MEDICAL PROCEDURES - OTHER, SPECIFY | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | CTCAE (Unspecified) | View |
| HOT FLASHES | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (Unspecified) | View |
| HYPERTENSION | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (Unspecified) | View |
| HYPOTENSION | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (Unspecified) | View |
| THROMBOEMBOLIC EVENT | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (Unspecified) | View |
| COLITIS | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| CONSTIPATION | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| DENTAL CARIES | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| DIARRHEA | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| DRY MOUTH | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| DYSPEPSIA | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| FLATULENCE | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| Dysphagia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| GINGIVAL PAIN | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| MUCOSITIS ORAL | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| NAUSEA | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| ORAL DYSESTHESIA | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| ORAL HEMORRHAGE | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| RECTAL FISTULA | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| SMALL INTESTINAL OBSTRUCTION | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| TOOTHACHE | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| VOMITING | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| CHILLS | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (Unspecified) | View |
| EDEMA FACE | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (Unspecified) | View |
| EDEMA LIMBS | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (Unspecified) | View |
| FATIGUE | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (Unspecified) | View |
| FEVER | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (Unspecified) | View |
| FLU LIKE SYMPTOMS | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (Unspecified) | View |
| GAIT DISTURBANCE | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (Unspecified) | View |
| NON-CARDIAC CHEST PAIN | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (Unspecified) | View |
| PAIN | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (Unspecified) | View |
| ANORECTAL INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (Unspecified) | View |
| BLADDER INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (Unspecified) | View |
| BRONCHIAL INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (Unspecified) | View |
| INFECTIONS AND INFESTATIONS - OTHER, SPECIFY | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (Unspecified) | View |
| INFECTIONS AND INFESTATIONS - OTHER, SPECIFY | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (Unspecified) | View |
| INFECTIONS AND INFESTATIONS - OTHER, SPECIFY | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (Unspecified) | View |
| LUNG INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (Unspecified) | View |
| PAPULOPUSTULAR RASH | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (Unspecified) | View |
| SINUSITIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (Unspecified) | View |
| SKIN INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (Unspecified) | View |
| THRUSH | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (Unspecified) | View |
| TOOTH INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (Unspecified) | View |
| UPPER RESPIRATORY INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (Unspecified) | View |
| BRUISING | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (Unspecified) | View |
| FALL | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (Unspecified) | View |
| INFUSION RELATED REACTION | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (Unspecified) | View |
| ALANINE AMINOTRANSFERASE INCREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (Unspecified) | View |
| ALKALINE PHOSPHATASE INCREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (Unspecified) | View |
| ASPARTATE AMINOTRANSFERASE INCREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (Unspecified) | View |
| BLOOD LACTATE DEHYDROGENASE INCREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (Unspecified) | View |
| CD4 LYMPHOCYTES DECREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (Unspecified) | View |
| CREATININE INCREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (Unspecified) | View |
| INVESTIGATIONS - OTHER, SPECIFY | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (Unspecified) | View |
| INVESTIGATIONS - OTHER, SPECIFY | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (Unspecified) | View |
| INVESTIGATIONS - OTHER, SPECIFY | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (Unspecified) | View |
| LIPASE INCREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (Unspecified) | View |
| LYMPHOCYTE COUNT DECREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (Unspecified) | View |
| NEUTROPHIL COUNT DECREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (Unspecified) | View |
| PLATELET COUNT DECREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (Unspecified) | View |
| SERUM AMYLASE INCREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (Unspecified) | View |
| THYROID STIMULATING HORMONE INCREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (Unspecified) | View |
| WEIGHT GAIN | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (Unspecified) | View |
| WEIGHT LOSS | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (Unspecified) | View |
| WHITE BLOOD CELL DECREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (Unspecified) | View |
| ANOREXIA | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (Unspecified) | View |
| DEHYDRATION | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (Unspecified) | View |
| HYPERGLYCEMIA | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (Unspecified) | View |
| HYPERKALEMIA | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (Unspecified) | View |
| HYPERNATREMIA | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (Unspecified) | View |
| HYPOALBUMINEMIA | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (Unspecified) | View |
| HYPOCALCEMIA | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (Unspecified) | View |
| HYPOGLYCEMIA | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (Unspecified) | View |
| HYPONATREMIA | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (Unspecified) | View |
| HYPOPHOSPHATEMIA | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (Unspecified) | View |
| METABOLISM AND NUTRITION DISORDERS - OTHER, SPECIFY | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (Unspecified) | View |
| ARTHRALGIA | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | View |
| ARTHRITIS | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | View |
| BACK PAIN | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | View |
| FLANK PAIN | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | View |
| GENERALIZED MUSCLE WEAKNESS | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | View |
| MUSCLE CRAMP | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | View |
| MYALGIA | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | View |
| NECK PAIN | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | View |
| PAIN IN EXTREMITY | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | View |
| TUMOR PAIN | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (Unspecified) | View |
| DIZZINESS | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (Unspecified) | View |
| DYSGEUSIA | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (Unspecified) | View |
| ANAL PAIN | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| BLOATING | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| ANEMIA | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (Unspecified) | View |
| BLOOD AND LYMPHATIC SYSTEM DISORDERS - OTHER, SPECIFY | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (Unspecified) | View |
| SINUS BRADYCARDIA | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (Unspecified) | View |
| EAR AND LABYRINTH DISORDERS - OTHER, SPECIFY | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAE (Unspecified) | View |
| EAR PAIN | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAE (Unspecified) | View |
| HYPOTHYROIDISM | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCAE (Unspecified) | View |
| BLURRED VISION | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (Unspecified) | View |
| DRY EYE | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (Unspecified) | View |
| EYE DISORDERS - OTHER, SPECIFY | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (Unspecified) | View |
| EYE DISORDERS - OTHER, SPECIFY | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (Unspecified) | View |
| RETINAL VASCULAR DISORDER | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (Unspecified) | View |
| UVEITIS | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (Unspecified) | View |
| ABDOMINAL PAIN | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| ANAL HEMORRHAGE | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |