Time Frame |
Up to 5 years
|
Adverse Event Reporting Description |
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
|
|
Arm/Group Title
|
Part A: 3 mg/kg Nivolumab
|
Part A PK: 3 mg/kg Nivolumab
|
Part B: 3 mg/kg Nivolumab
|
Part C: 1mg/kg Nivolumab and 1mg/kg Ipilimumab
|
Part C: 3mg/kg Nivolumab and 1mg/kg Ipilimumab
|
Part C PK: 3mg/kg Nivolumab and 1mg/kg Ipilimumab
|
Part D: 3mg/kg Nivolumab and 1mg/kg Ipilimumab
|
Part E: 1mg/kg Nivolumab and 3mg/kg Ipilimumab
|
Arm/Group Description |
Phase 1: Patients with solid tumors...
|
Phase 1: Patients with solid tumors...
|
Patients with relapsed or refractor...
|
Phase 1: patients with solid tumors...
|
Phase 1: patients with solid tumors...
|
Phase 1: patients with solid tumors...
|
Patients with relapsed or refractor...
|
Patients with relapsed or refractor...
|
Arm/Group Description |
Phase 1: Patients with solid tumors, excluding brain and CNS tumors
|
Phase 1: Patients with solid tumors, excluding brain and CNS tumors receive
|
Patients with relapsed or refractory neuroblastoma, osteosarcoma, rhabdomyosarcoma, Ewing Sarcoma or Peripheral PNET, Hodgkin Lymphoma, Non-Hodgkin Lymphoma, unresectable melanoma or metastatic melanoma or relapsed melanoma or refractory melanoma, neuroblastoma (MIBG evaluable without RECIST evaluable disease)
|
Phase 1: patients with solid tumors, excluding brain and CNS tumors
|
Phase 1: patients with solid tumors, excluding brain and CNS tumors
|
Phase 1: patients with solid tumors, excluding brain and CNS tumors
|
Patients with relapsed or refractory neuroblastoma, osteosarcoma, rhabdomyosarcoma, Ewing Sarcoma or Peripheral PNET, Non-Hodgkin Lymphoma, neuroblastoma (MIBG evaluable without RECIST evaluable disease)
|
Patients with relapsed or refractory rhabdomyosarcoma, Ewing Sarcoma, or Peripheral PNET
|
|
|
Part A: 3 mg/kg Nivolumab
|
Part A PK: 3 mg/kg Nivolumab
|
Part B: 3 mg/kg Nivolumab
|
Part C: 1mg/kg Nivolumab and 1mg/kg Ipilimumab
|
Part C: 3mg/kg Nivolumab and 1mg/kg Ipilimumab
|
Part C PK: 3mg/kg Nivolumab and 1mg/kg Ipilimumab
|
Part D: 3mg/kg Nivolumab and 1mg/kg Ipilimumab
|
Part E: 1mg/kg Nivolumab and 3mg/kg Ipilimumab
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
3/7 (42.86%) |
3/6 (50.00%) |
38/72 (52.78%) |
2/6 (33.33%) |
4/6 (66.67%) |
4/6 (66.67%) |
19/29 (65.52%) |
1/8 (12.50%) |
|
|
Part A: 3 mg/kg Nivolumab
|
Part A PK: 3 mg/kg Nivolumab
|
Part B: 3 mg/kg Nivolumab
|
Part C: 1mg/kg Nivolumab and 1mg/kg Ipilimumab
|
Part C: 3mg/kg Nivolumab and 1mg/kg Ipilimumab
|
Part C PK: 3mg/kg Nivolumab and 1mg/kg Ipilimumab
|
Part D: 3mg/kg Nivolumab and 1mg/kg Ipilimumab
|
Part E: 1mg/kg Nivolumab and 3mg/kg Ipilimumab
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
6/7 (85.71%) |
6/6 (100.00%) |
70/72 (97.22%) |
4/6 (66.67%) |
6/6 (100.00%) |
5/6 (83.33%) |
26/29 (89.66%) |
7/8 (87.50%) |
Blood and lymphatic system disorders |
|
|
|
|
|
|
|
|
Anemia |
0/7 (0.00%) |
2/6 (33.33%) |
25/72 (34.72%) |
1/6 (16.67%) |
1/6 (16.67%) |
2/6 (33.33%) |
8/29 (27.59%) |
2/8 (25.00%) |
Febrile neutropenia |
1/7 (14.29%) |
0/6 (0.00%) |
9/72 (12.50%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
1/29 (3.45%) |
0/8 (0.00%) |
Cardiac disorders |
|
|
|
|
|
|
|
|
Cardiac arrest |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
1/8 (12.50%) |
Cardiac disorders - Other, TAMPONADE PHYSIOLOGY |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Restrictive cardiomyopathy |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Sinus bradycardia |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Ventricular arrhythmia |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
1/8 (12.50%) |
Ventricular fibrillation |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
1/8 (12.50%) |
Ear and labyrinth disorders |
|
|
|
|
|
|
|
|
Hearing impaired |
1/7 (14.29%) |
0/6 (0.00%) |
3/72 (4.17%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Endocrine disorders |
|
|
|
|
|
|
|
|
Hyperthyroidism |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
1/8 (12.50%) |
Eye disorders |
|
|
|
|
|
|
|
|
Eye disorders - Other, DECREASED VISION |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Eye disorders - Other, PRE-SEPTAL CELLULITIS |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Eye disorders - Other, REDUCED VISION |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Eye disorders - Other, RIGHT EYE SWELLING |
1/7 (14.29%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Eye disorders - Other, VISION LOSS |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Gastrointestinal disorders |
|
|
|
|
|
|
|
|
Abdominal distension |
0/7 (0.00%) |
0/6 (0.00%) |
2/72 (2.78%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Abdominal pain |
0/7 (0.00%) |
0/6 (0.00%) |
4/72 (5.56%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
3/29 (10.34%) |
0/8 (0.00%) |
Ascites |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Colitis |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
1/8 (12.50%) |
Colonic hemorrhage |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Colonic obstruction |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Diarrhea |
0/7 (0.00%) |
0/6 (0.00%) |
2/72 (2.78%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/29 (0.00%) |
1/8 (12.50%) |
Duodenal ulcer |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
1/8 (12.50%) |
Dysphagia |
0/7 (0.00%) |
1/6 (16.67%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Gastritis |
0/7 (0.00%) |
1/6 (16.67%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Gastrointestinal disorders - Other, DUODENITIS |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Malabsorption |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Mucositis oral |
0/7 (0.00%) |
1/6 (16.67%) |
4/72 (5.56%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Nausea |
0/7 (0.00%) |
0/6 (0.00%) |
3/72 (4.17%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
1/29 (3.45%) |
1/8 (12.50%) |
Obstruction gastric |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Pancreatitis |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Rectal fistula |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Upper gastrointestinal hemorrhage |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Vomiting |
0/7 (0.00%) |
0/6 (0.00%) |
6/72 (8.33%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/29 (0.00%) |
1/8 (12.50%) |
General disorders |
|
|
|
|
|
|
|
|
Death NOS |
0/7 (0.00%) |
0/6 (0.00%) |
2/72 (2.78%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
2/29 (6.90%) |
0/8 (0.00%) |
Edema limbs |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Fatigue |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
2/29 (6.90%) |
0/8 (0.00%) |
Fever |
1/7 (14.29%) |
0/6 (0.00%) |
3/72 (4.17%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/29 (0.00%) |
1/8 (12.50%) |
Gait disturbance |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Multi-organ failure |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Non-cardiac chest pain |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Pain |
0/7 (0.00%) |
0/6 (0.00%) |
4/72 (5.56%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Immune system disorders |
|
|
|
|
|
|
|
|
Allergic reaction |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
1/8 (12.50%) |
Autoimmune disorder |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Immune system disorders - Other, GVHD IN THE SETTING OF ALLOTRANSPLANT |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Infections and infestations |
|
|
|
|
|
|
|
|
Anorectal infection |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
1/8 (12.50%) |
Bronchial infection |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Catheter related infection |
1/7 (14.29%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Enterocolitis infectious |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Infections and infestations - Other, BLOOD |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Infections and infestations - Other, Enterococcus and Pseudomonas pyelonephritis |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
1/8 (12.50%) |
Kidney infection |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Lung infection |
0/7 (0.00%) |
1/6 (16.67%) |
4/72 (5.56%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Sepsis |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Skin infection |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
1/8 (12.50%) |
Upper respiratory infection |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Urinary tract infection |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
1/29 (3.45%) |
1/8 (12.50%) |
Vaginal infection |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Wound infection |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Injury, poisoning and procedural complications |
|
|
|
|
|
|
|
|
Dermatitis radiation |
0/7 (0.00%) |
1/6 (16.67%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Fall |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Fracture |
0/7 (0.00%) |
0/6 (0.00%) |
2/72 (2.78%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Intestinal stoma leak |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Vascular access complication |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
1/8 (12.50%) |
Investigations |
|
|
|
|
|
|
|
|
Alanine aminotransferase increased |
0/7 (0.00%) |
0/6 (0.00%) |
5/72 (6.94%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/6 (0.00%) |
2/29 (6.90%) |
2/8 (25.00%) |
Alkaline phosphatase increased |
0/7 (0.00%) |
0/6 (0.00%) |
5/72 (6.94%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Aspartate aminotransferase increased |
0/7 (0.00%) |
0/6 (0.00%) |
4/72 (5.56%) |
0/6 (0.00%) |
2/6 (33.33%) |
0/6 (0.00%) |
3/29 (10.34%) |
1/8 (12.50%) |
Blood bilirubin increased |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Creatinine increased |
0/7 (0.00%) |
0/6 (0.00%) |
3/72 (4.17%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Ejection fraction decreased |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
1/8 (12.50%) |
Electrocardiogram QT corrected interval prolonged |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
1/8 (12.50%) |
GGT increased |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Hemoglobin increased |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Investigations - Other, CRP INCREASED |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Investigations - Other, SIADH |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Lipase increased |
0/7 (0.00%) |
1/6 (16.67%) |
2/72 (2.78%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
4/29 (13.79%) |
1/8 (12.50%) |
Lymphocyte count decreased |
3/7 (42.86%) |
3/6 (50.00%) |
35/72 (48.61%) |
1/6 (16.67%) |
3/6 (50.00%) |
0/6 (0.00%) |
12/29 (41.38%) |
5/8 (62.50%) |
Neutrophil count decreased |
3/7 (42.86%) |
1/6 (16.67%) |
26/72 (36.11%) |
0/6 (0.00%) |
1/6 (16.67%) |
1/6 (16.67%) |
2/29 (6.90%) |
2/8 (25.00%) |
Platelet count decreased |
3/7 (42.86%) |
0/6 (0.00%) |
21/72 (29.17%) |
0/6 (0.00%) |
1/6 (16.67%) |
1/6 (16.67%) |
4/29 (13.79%) |
1/8 (12.50%) |
Serum amylase increased |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Urine output decreased |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
2/29 (6.90%) |
0/8 (0.00%) |
Weight gain |
0/7 (0.00%) |
0/6 (0.00%) |
4/72 (5.56%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Weight loss |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
1/29 (3.45%) |
0/8 (0.00%) |
White blood cell decreased |
1/7 (14.29%) |
2/6 (33.33%) |
19/72 (26.39%) |
0/6 (0.00%) |
1/6 (16.67%) |
1/6 (16.67%) |
3/29 (10.34%) |
2/8 (25.00%) |
Metabolism and nutrition disorders |
|
|
|
|
|
|
|
|
Acidosis |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Anorexia |
0/7 (0.00%) |
0/6 (0.00%) |
8/72 (11.11%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
4/29 (13.79%) |
0/8 (0.00%) |
Dehydration |
0/7 (0.00%) |
1/6 (16.67%) |
5/72 (6.94%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/6 (0.00%) |
4/29 (13.79%) |
1/8 (12.50%) |
Glucose intolerance |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/29 (0.00%) |
0/8 (0.00%) |
Hypercalcemia |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Hyperglycemia |
0/7 (0.00%) |
0/6 (0.00%) |
2/72 (2.78%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/29 (0.00%) |
0/8 (0.00%) |
Hyperkalemia |
0/7 (0.00%) |
0/6 (0.00%) |
3/72 (4.17%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
1/8 (12.50%) |
Hypermagnesemia |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
1/8 (12.50%) |
Hypoalbuminemia |
1/7 (14.29%) |
0/6 (0.00%) |
4/72 (5.56%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Hypocalcemia |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Hypokalemia |
1/7 (14.29%) |
0/6 (0.00%) |
8/72 (11.11%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
3/29 (10.34%) |
0/8 (0.00%) |
Hyponatremia |
1/7 (14.29%) |
1/6 (16.67%) |
5/72 (6.94%) |
2/6 (33.33%) |
1/6 (16.67%) |
0/6 (0.00%) |
4/29 (13.79%) |
0/8 (0.00%) |
Hypophosphatemia |
1/7 (14.29%) |
0/6 (0.00%) |
4/72 (5.56%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
3/29 (10.34%) |
1/8 (12.50%) |
Obesity |
0/7 (0.00%) |
1/6 (16.67%) |
2/72 (2.78%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
1/29 (3.45%) |
0/8 (0.00%) |
Musculoskeletal and connective tissue disorders |
|
|
|
|
|
|
|
|
Arthralgia |
0/7 (0.00%) |
0/6 (0.00%) |
2/72 (2.78%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Back pain |
0/7 (0.00%) |
0/6 (0.00%) |
6/72 (8.33%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Bone pain |
0/7 (0.00%) |
0/6 (0.00%) |
3/72 (4.17%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Chest wall pain |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Flank pain |
0/7 (0.00%) |
0/6 (0.00%) |
3/72 (4.17%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Generalized muscle weakness |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Joint range of motion decreased |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Muscle weakness lower limb |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Musculoskeletal and connective tissue disorder - Other, MUSCLE SPASMS |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Musculoskeletal and connective tissue disorder - Other, OSTEOPENIA |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Neck pain |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Pain in extremity |
0/7 (0.00%) |
0/6 (0.00%) |
3/72 (4.17%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/6 (0.00%) |
3/29 (10.34%) |
0/8 (0.00%) |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
|
|
|
|
|
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, DISEASE PROGRESSION |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, NEUROBLASTOMA PROGRESSI |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, PROGRESSIVE DISEASE |
2/7 (28.57%) |
2/6 (33.33%) |
30/72 (41.67%) |
2/6 (33.33%) |
3/6 (50.00%) |
4/6 (66.67%) |
9/29 (31.03%) |
0/8 (0.00%) |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, PROGRESSIVE DISEASE (EW |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, Progressive Disease |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, due to disease |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, tumor progression |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Tumor pain |
0/7 (0.00%) |
1/6 (16.67%) |
11/72 (15.28%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
1/8 (12.50%) |
Nervous system disorders |
|
|
|
|
|
|
|
|
Cognitive disturbance |
0/7 (0.00%) |
0/6 (0.00%) |
2/72 (2.78%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Depressed level of consciousness |
0/7 (0.00%) |
1/6 (16.67%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Encephalopathy |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/29 (0.00%) |
0/8 (0.00%) |
Hydrocephalus |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Nervous system disorders - Other, Altered mental status (AMS) |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Nervous system disorders - Other, Central nervous system dysfunction |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Nervous system disorders - Other, SPINAL CORD COMPRESSION - CERVICAL SPINE |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Nervous system disorders - Other, SPINAL CORD COMPRESSION - THORACIC SPINE |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Neuralgia |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Paresthesia |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Peripheral motor neuropathy |
0/7 (0.00%) |
1/6 (16.67%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Peripheral sensory neuropathy |
0/7 (0.00%) |
0/6 (0.00%) |
2/72 (2.78%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Phantom pain |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Seizure |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/29 (0.00%) |
1/8 (12.50%) |
Syncope |
0/7 (0.00%) |
0/6 (0.00%) |
2/72 (2.78%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Vasovagal reaction |
0/7 (0.00%) |
0/6 (0.00%) |
2/72 (2.78%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Psychiatric disorders |
|
|
|
|
|
|
|
|
Anxiety |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Depression |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Psychiatric disorders - Other, AUTISM |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Renal and urinary disorders |
|
|
|
|
|
|
|
|
Acute kidney injury |
0/7 (0.00%) |
0/6 (0.00%) |
3/72 (4.17%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Hematuria |
0/7 (0.00%) |
0/6 (0.00%) |
3/72 (4.17%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Renal and urinary disorders - Other, Left Hydronephrosis |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Renal and urinary disorders - Other, RENAL IMPAIRMENT |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Renal and urinary disorders - Other, RIGHT HYDRONEPHROSIS |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Renal calculi |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Renal colic |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Urinary retention |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Urinary tract obstruction |
1/7 (14.29%) |
0/6 (0.00%) |
4/72 (5.56%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
1/29 (3.45%) |
2/8 (25.00%) |
Reproductive system and breast disorders |
|
|
|
|
|
|
|
|
Irregular menstruation |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/29 (0.00%) |
0/8 (0.00%) |
Penile pain |
0/7 (0.00%) |
1/6 (16.67%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Vaginal hemorrhage |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Respiratory, thoracic and mediastinal disorders |
|
|
|
|
|
|
|
|
Adult respiratory distress syndrome |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Bronchopulmonary hemorrhage |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Cough |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Dyspnea |
0/7 (0.00%) |
0/6 (0.00%) |
6/72 (8.33%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
6/29 (20.69%) |
1/8 (12.50%) |
Epistaxis |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Hoarseness |
0/7 (0.00%) |
1/6 (16.67%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Hypoxia |
0/7 (0.00%) |
0/6 (0.00%) |
5/72 (6.94%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/6 (0.00%) |
5/29 (17.24%) |
0/8 (0.00%) |
Laryngeal edema |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Pleural effusion |
1/7 (14.29%) |
2/6 (33.33%) |
4/72 (5.56%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
5/29 (17.24%) |
1/8 (12.50%) |
Pneumonitis |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
1/8 (12.50%) |
Respiratory failure |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
2/29 (6.90%) |
0/8 (0.00%) |
Respiratory, thoracic and mediastinal disorders - Other, ASTHMA |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Sleep apnea |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/29 (0.00%) |
0/8 (0.00%) |
Sore throat |
0/7 (0.00%) |
0/6 (0.00%) |
2/72 (2.78%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Stridor |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Skin and subcutaneous tissue disorders |
|
|
|
|
|
|
|
|
Hyperhidrosis |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Pruritus |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Rash acneiform |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/29 (0.00%) |
0/8 (0.00%) |
Rash maculo-papular |
0/7 (0.00%) |
0/6 (0.00%) |
2/72 (2.78%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/29 (0.00%) |
1/8 (12.50%) |
Skin and subcutaneous tissue disorders - Other, CYSTIC ACNE RASH |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Stevens-Johnson syndrome |
1/7 (14.29%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Surgical and medical procedures |
|
|
|
|
|
|
|
|
Surgical and medical procedures - Other, NEPHROSTOMY |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Surgical and medical procedures - Other, SIGMOID LOOP COLOSTOMY |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Surgical and medical procedures - Other, ULTRASOUND GUIDED CATHETER LUMBAR PLEXUS NERVE BLOCK |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Vascular disorders |
|
|
|
|
|
|
|
|
Hematoma |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Hypertension |
0/7 (0.00%) |
0/6 (0.00%) |
2/72 (2.78%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
3/29 (10.34%) |
1/8 (12.50%) |
Hypotension |
1/7 (14.29%) |
0/6 (0.00%) |
2/72 (2.78%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
1/8 (12.50%) |
Thromboembolic event |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Indicates events were collected by systematic assessment
|
|
Frequency Threshold for Reporting Other Adverse Events
|
0%
|
|
Part A: 3 mg/kg Nivolumab
|
Part A PK: 3 mg/kg Nivolumab
|
Part B: 3 mg/kg Nivolumab
|
Part C: 1mg/kg Nivolumab and 1mg/kg Ipilimumab
|
Part C: 3mg/kg Nivolumab and 1mg/kg Ipilimumab
|
Part C PK: 3mg/kg Nivolumab and 1mg/kg Ipilimumab
|
Part D: 3mg/kg Nivolumab and 1mg/kg Ipilimumab
|
Part E: 1mg/kg Nivolumab and 3mg/kg Ipilimumab
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
7/7 (100.00%) |
6/6 (100.00%) |
72/72 (100.00%) |
6/6 (100.00%) |
6/6 (100.00%) |
6/6 (100.00%) |
29/29 (100.00%) |
8/8 (100.00%) |
Blood and lymphatic system disorders |
|
|
|
|
|
|
|
|
Anemia |
6/7 (85.71%) |
6/6 (100.00%) |
62/72 (86.11%) |
5/6 (83.33%) |
6/6 (100.00%) |
6/6 (100.00%) |
20/29 (68.97%) |
6/8 (75.00%) |
Blood and lymphatic system disorders - Other, CRP ELEVATED |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Blood and lymphatic system disorders - Other, LEFT INGUINAL LYMPHADENOPATHY |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Blood and lymphatic system disorders - Other, MACROCYTOSIS |
1/7 (14.29%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Bone marrow hypocellular |
0/7 (0.00%) |
1/6 (16.67%) |
2/72 (2.78%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Disseminated intravascular coagulation |
1/7 (14.29%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Lymph node pain |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Cardiac disorders |
|
|
|
|
|
|
|
|
Cardiac disorders - Other, BENIGN CARDIAC MURMUR |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Cardiac disorders - Other, ECTOPIC ATRIAL RHYTHM |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Cardiac disorders - Other, HYPERTROPHIC CARDIOMYOPATHY |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Cardiac disorders - Other, RIGHT ATRIAL HYPERTROPHY |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Conduction disorder |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Heart failure |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
1/8 (12.50%) |
Mitral valve disease |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Palpitations |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Paroxysmal atrial tachycardia |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
1/8 (12.50%) |
Pericardial effusion |
0/7 (0.00%) |
0/6 (0.00%) |
6/72 (8.33%) |
2/6 (33.33%) |
1/6 (16.67%) |
0/6 (0.00%) |
3/29 (10.34%) |
0/8 (0.00%) |
Sinus bradycardia |
0/7 (0.00%) |
0/6 (0.00%) |
3/72 (4.17%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/6 (0.00%) |
4/29 (13.79%) |
1/8 (12.50%) |
Sinus tachycardia |
5/7 (71.43%) |
3/6 (50.00%) |
28/72 (38.89%) |
2/6 (33.33%) |
2/6 (33.33%) |
3/6 (50.00%) |
19/29 (65.52%) |
3/8 (37.50%) |
Supraventricular tachycardia |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Tricuspid valve disease |
0/7 (0.00%) |
1/6 (16.67%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Ventricular arrhythmia |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
1/8 (12.50%) |
Ear and labyrinth disorders |
|
|
|
|
|
|
|
|
Ear and labyrinth disorders - Other, EAR INFECTION |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Ear pain |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
External ear pain |
0/7 (0.00%) |
1/6 (16.67%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Hearing impaired |
1/7 (14.29%) |
1/6 (16.67%) |
3/72 (4.17%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
4/29 (13.79%) |
1/8 (12.50%) |
Tinnitus |
0/7 (0.00%) |
0/6 (0.00%) |
2/72 (2.78%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Endocrine disorders |
|
|
|
|
|
|
|
|
Cushingoid |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/6 (0.00%) |
3/29 (10.34%) |
0/8 (0.00%) |
Delayed puberty |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Endocrine disorders - Other, ASYMPTOMATIC TSH ELEVATION |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Endocrine disorders - Other, ELEVATED T3 |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Endocrine disorders - Other, ELEVATED TSH |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Endocrine disorders - Other, TSH ELEVATION |
0/7 (0.00%) |
1/6 (16.67%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Endocrine disorders - Other, TSH decreased |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
1/8 (12.50%) |
Endocrine disorders - Other, thyroiditis |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
1/8 (12.50%) |
Hyperparathyroidism |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Hyperthyroidism |
0/7 (0.00%) |
1/6 (16.67%) |
8/72 (11.11%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
2/29 (6.90%) |
2/8 (25.00%) |
Hypothyroidism |
3/7 (42.86%) |
1/6 (16.67%) |
19/72 (26.39%) |
0/6 (0.00%) |
2/6 (33.33%) |
2/6 (33.33%) |
9/29 (31.03%) |
2/8 (25.00%) |
Eye disorders |
|
|
|
|
|
|
|
|
Blurred vision |
0/7 (0.00%) |
0/6 (0.00%) |
4/72 (5.56%) |
1/6 (16.67%) |
1/6 (16.67%) |
0/6 (0.00%) |
5/29 (17.24%) |
1/8 (12.50%) |
Conjunctivitis |
0/7 (0.00%) |
0/6 (0.00%) |
3/72 (4.17%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Dry eye |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
2/29 (6.90%) |
0/8 (0.00%) |
Eye disorders - Other, ANISOCORIA |
1/7 (14.29%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Eye disorders - Other, ASTIGMATISM |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Eye disorders - Other, ASYMMETRIC PUPILS |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Eye disorders - Other, CRUSTY EYES |
1/7 (14.29%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Eye disorders - Other, DIPLOPIA |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Eye disorders - Other, EYE DISCHARGE |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Eye disorders - Other, Epicleritis |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
1/8 (12.50%) |
Eye disorders - Other, HORNER'S SYNDROME |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Eye disorders - Other, LEFT ORBIT RECONSTRUCTION |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Eye disorders - Other, MYOPIA |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Eye disorders - Other, PAIN, PHOTOPHOBIA AND LID SWELLING OF OD) |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Eye disorders - Other, PTOSIS |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/29 (0.00%) |
0/8 (0.00%) |
Eye disorders - Other, REFRACTIVE ERROR REQUIRING GLASSES |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Eye disorders - Other, VISION BLACK OUTS |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Eye disorders - Other, VISUAL IMPAIREMENT |
1/7 (14.29%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Eye pain |
1/7 (14.29%) |
0/6 (0.00%) |
3/72 (4.17%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/6 (0.00%) |
2/29 (6.90%) |
0/8 (0.00%) |
Eyelid function disorder |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Flashing lights |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Floaters |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Keratitis |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Optic nerve disorder |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Photophobia |
1/7 (14.29%) |
0/6 (0.00%) |
0/72 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Retinopathy |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Scleral disorder |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Uveitis |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Watering eyes |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Gastrointestinal disorders |
|
|
|
|
|
|
|
|
Abdominal distension |
0/7 (0.00%) |
0/6 (0.00%) |
2/72 (2.78%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
6/29 (20.69%) |
3/8 (37.50%) |
Abdominal pain |
1/7 (14.29%) |
2/6 (33.33%) |
22/72 (30.56%) |
1/6 (16.67%) |
2/6 (33.33%) |
1/6 (16.67%) |
8/29 (27.59%) |
6/8 (75.00%) |
Anal fistula |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Ascites |
0/7 (0.00%) |
0/6 (0.00%) |
2/72 (2.78%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
1/8 (12.50%) |
Bloating |
0/7 (0.00%) |
0/6 (0.00%) |
3/72 (4.17%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Cheilitis |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Colitis |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
1/8 (12.50%) |
Colonic obstruction |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Constipation |
3/7 (42.86%) |
6/6 (100.00%) |
28/72 (38.89%) |
2/6 (33.33%) |
3/6 (50.00%) |
2/6 (33.33%) |
14/29 (48.28%) |
3/8 (37.50%) |
Dental caries |
0/7 (0.00%) |
0/6 (0.00%) |
7/72 (9.72%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
2/29 (6.90%) |
0/8 (0.00%) |
Diarrhea |
3/7 (42.86%) |
1/6 (16.67%) |
17/72 (23.61%) |
1/6 (16.67%) |
0/6 (0.00%) |
1/6 (16.67%) |
8/29 (27.59%) |
4/8 (50.00%) |
Dry mouth |
0/7 (0.00%) |
0/6 (0.00%) |
2/72 (2.78%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
6/29 (20.69%) |
1/8 (12.50%) |
Dyspepsia |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Dysphagia |
1/7 (14.29%) |
0/6 (0.00%) |
2/72 (2.78%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Esophageal pain |
0/7 (0.00%) |
1/6 (16.67%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Esophagitis |
0/7 (0.00%) |
1/6 (16.67%) |
2/72 (2.78%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Fecal incontinence |
0/7 (0.00%) |
0/6 (0.00%) |
2/72 (2.78%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
2/29 (6.90%) |
0/8 (0.00%) |
Flatulence |
1/7 (14.29%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
3/29 (10.34%) |
0/8 (0.00%) |
Gastritis |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
2/29 (6.90%) |
0/8 (0.00%) |
Gastroesophageal reflux disease |
0/7 (0.00%) |
0/6 (0.00%) |
4/72 (5.56%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
4/29 (13.79%) |
1/8 (12.50%) |
Gastrointestinal disorders - Other, ABDOMINAL CRAMPING |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Gastrointestinal disorders - Other, BURPING |
1/7 (14.29%) |
1/6 (16.67%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Gastrointestinal disorders - Other, HEARTBURN |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Gastrointestinal disorders - Other, INCREASED ORAL SECRETIONS |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Gastrointestinal disorders - Other, LOOSE TEETH |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Gastrointestinal disorders - Other, MOUTH SORE |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Gastrointestinal disorders - Other, ORAL PLAQUES |
1/7 (14.29%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Gastrointestinal disorders - Other, THRUSH |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Gastrointestinal disorders - Other, TOOTH SENSITIVITY |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Gastrointestinal pain |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
2/29 (6.90%) |
0/8 (0.00%) |
Gingival pain |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/29 (0.00%) |
0/8 (0.00%) |
Hemorrhoidal hemorrhage |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Hemorrhoids |
0/7 (0.00%) |
0/6 (0.00%) |
2/72 (2.78%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Lip pain |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Mucositis oral |
0/7 (0.00%) |
0/6 (0.00%) |
2/72 (2.78%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
1/8 (12.50%) |
Nausea |
4/7 (57.14%) |
4/6 (66.67%) |
36/72 (50.00%) |
1/6 (16.67%) |
1/6 (16.67%) |
2/6 (33.33%) |
15/29 (51.72%) |
4/8 (50.00%) |
Obstruction gastric |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Oral hemorrhage |
0/7 (0.00%) |
1/6 (16.67%) |
2/72 (2.78%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Oral pain |
0/7 (0.00%) |
1/6 (16.67%) |
4/72 (5.56%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
2/29 (6.90%) |
1/8 (12.50%) |
Pancreatitis |
0/7 (0.00%) |
1/6 (16.67%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Periodontal disease |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Rectal hemorrhage |
0/7 (0.00%) |
0/6 (0.00%) |
2/72 (2.78%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Rectal pain |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Stomach pain |
0/7 (0.00%) |
1/6 (16.67%) |
5/72 (6.94%) |
0/6 (0.00%) |
1/6 (16.67%) |
1/6 (16.67%) |
5/29 (17.24%) |
0/8 (0.00%) |
Tooth discoloration |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Toothache |
0/7 (0.00%) |
1/6 (16.67%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Vomiting |
1/7 (14.29%) |
3/6 (50.00%) |
30/72 (41.67%) |
2/6 (33.33%) |
1/6 (16.67%) |
2/6 (33.33%) |
17/29 (58.62%) |
4/8 (50.00%) |
General disorders |
|
|
|
|
|
|
|
|
Chills |
2/7 (28.57%) |
0/6 (0.00%) |
5/72 (6.94%) |
0/6 (0.00%) |
1/6 (16.67%) |
1/6 (16.67%) |
6/29 (20.69%) |
2/8 (25.00%) |
Edema face |
0/7 (0.00%) |
1/6 (16.67%) |
4/72 (5.56%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
1/8 (12.50%) |
Edema limbs |
2/7 (28.57%) |
0/6 (0.00%) |
8/72 (11.11%) |
0/6 (0.00%) |
1/6 (16.67%) |
1/6 (16.67%) |
7/29 (24.14%) |
3/8 (37.50%) |
Edema trunk |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Facial pain |
0/7 (0.00%) |
1/6 (16.67%) |
2/72 (2.78%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Fatigue |
4/7 (57.14%) |
4/6 (66.67%) |
48/72 (66.67%) |
2/6 (33.33%) |
4/6 (66.67%) |
3/6 (50.00%) |
20/29 (68.97%) |
8/8 (100.00%) |
Fever |
2/7 (28.57%) |
4/6 (66.67%) |
33/72 (45.83%) |
2/6 (33.33%) |
3/6 (50.00%) |
2/6 (33.33%) |
14/29 (48.28%) |
3/8 (37.50%) |
Flu like symptoms |
0/7 (0.00%) |
0/6 (0.00%) |
2/72 (2.78%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
1/29 (3.45%) |
1/8 (12.50%) |
Gait disturbance |
3/7 (42.86%) |
2/6 (33.33%) |
9/72 (12.50%) |
1/6 (16.67%) |
0/6 (0.00%) |
1/6 (16.67%) |
5/29 (17.24%) |
1/8 (12.50%) |
General disorders and administration site conditions - Other, DECREASED FUNCTIONAL MOBILITY/ACTIVITY |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
General disorders and administration site conditions - Other, GUM SWELLING, LOWER LEFT SIDE |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
General disorders and administration site conditions - Other, HEAD ABRASION |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Hypothermia |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Injection site reaction |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Irritability |
1/7 (14.29%) |
2/6 (33.33%) |
5/72 (6.94%) |
1/6 (16.67%) |
0/6 (0.00%) |
1/6 (16.67%) |
4/29 (13.79%) |
0/8 (0.00%) |
Localized edema |
0/7 (0.00%) |
0/6 (0.00%) |
3/72 (4.17%) |
2/6 (33.33%) |
0/6 (0.00%) |
1/6 (16.67%) |
5/29 (17.24%) |
0/8 (0.00%) |
Malaise |
0/7 (0.00%) |
0/6 (0.00%) |
5/72 (6.94%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/29 (0.00%) |
1/8 (12.50%) |
Non-cardiac chest pain |
0/7 (0.00%) |
2/6 (33.33%) |
10/72 (13.89%) |
1/6 (16.67%) |
2/6 (33.33%) |
0/6 (0.00%) |
7/29 (24.14%) |
4/8 (50.00%) |
Pain |
1/7 (14.29%) |
3/6 (50.00%) |
19/72 (26.39%) |
1/6 (16.67%) |
1/6 (16.67%) |
1/6 (16.67%) |
6/29 (20.69%) |
4/8 (50.00%) |
Immune system disorders |
|
|
|
|
|
|
|
|
Allergic reaction |
0/7 (0.00%) |
1/6 (16.67%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Cytokine release syndrome |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Immune system disorders - Other, HYPOGAMMAGLOBULINEMIA |
1/7 (14.29%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Infections and infestations |
|
|
|
|
|
|
|
|
Enterocolitis infectious |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Eye infection |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Infections and infestations - Other, C. DIFFICILE |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Infections and infestations - Other, BACTEREMIA |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Infections and infestations - Other, C.DIFF |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Infections and infestations - Other, E.COLI |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Infections and infestations - Other, ESR ELEVATED |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Infections and infestations - Other, INFLUENZA B |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Infections and infestations - Other, KLEBSIELLA BACTEREMIA |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Infections and infestations - Other, POS blood CX |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Infections and infestations - Other, RESPIRATORY SYNCYTIAL VIRUS RNA |
0/7 (0.00%) |
1/6 (16.67%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Infections and infestations - Other, RHINORREA |
0/7 (0.00%) |
1/6 (16.67%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Infections and infestations - Other, RHINOVIRUS/ENTEROVIRUS |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Infections and infestations - Other, STERILE ABCESS |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Infections and infestations - Other, Strep throat |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Infections and infestations - Other, THRUSH |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Infections and infestations - Other, UPPER RESPIRATORY INFECTION |
0/7 (0.00%) |
1/6 (16.67%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Lip infection |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Lung infection |
1/7 (14.29%) |
0/6 (0.00%) |
3/72 (4.17%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
2/29 (6.90%) |
0/8 (0.00%) |
Mucosal infection |
0/7 (0.00%) |
1/6 (16.67%) |
3/72 (4.17%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
2/29 (6.90%) |
0/8 (0.00%) |
Otitis media |
0/7 (0.00%) |
1/6 (16.67%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Paronychia |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Pharyngitis |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Rash pustular |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
1/8 (12.50%) |
Rhinitis infective |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
2/29 (6.90%) |
0/8 (0.00%) |
Sinusitis |
0/7 (0.00%) |
0/6 (0.00%) |
2/72 (2.78%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
3/29 (10.34%) |
0/8 (0.00%) |
Skin infection |
0/7 (0.00%) |
0/6 (0.00%) |
2/72 (2.78%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Soft tissue infection |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Upper respiratory infection |
0/7 (0.00%) |
0/6 (0.00%) |
8/72 (11.11%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/6 (0.00%) |
5/29 (17.24%) |
1/8 (12.50%) |
Urinary tract infection |
0/7 (0.00%) |
0/6 (0.00%) |
5/72 (6.94%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/29 (0.00%) |
2/8 (25.00%) |
Wound infection |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Injury, poisoning and procedural complications |
|
|
|
|
|
|
|
|
Ankle fracture |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Bruising |
1/7 (14.29%) |
1/6 (16.67%) |
8/72 (11.11%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
3/29 (10.34%) |
0/8 (0.00%) |
Burn |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Dermatitis radiation |
1/7 (14.29%) |
0/6 (0.00%) |
3/72 (4.17%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Fall |
1/7 (14.29%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
2/8 (25.00%) |
Fracture |
0/7 (0.00%) |
0/6 (0.00%) |
4/72 (5.56%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Infusion related reaction |
1/7 (14.29%) |
0/6 (0.00%) |
4/72 (5.56%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
1/29 (3.45%) |
1/8 (12.50%) |
Injury, poisoning and procedural complications - Other, Forehead laceration |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
1/8 (12.50%) |
Intestinal stoma leak |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Seroma |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Spinal fracture |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Wound complication |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
1/8 (12.50%) |
Wound dehiscence |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Investigations |
|
|
|
|
|
|
|
|
Activated partial thromboplastin time prolonged |
1/7 (14.29%) |
0/6 (0.00%) |
10/72 (13.89%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
6/29 (20.69%) |
1/8 (12.50%) |
Alanine aminotransferase increased |
3/7 (42.86%) |
2/6 (33.33%) |
34/72 (47.22%) |
3/6 (50.00%) |
3/6 (50.00%) |
2/6 (33.33%) |
11/29 (37.93%) |
4/8 (50.00%) |
Alkaline phosphatase increased |
3/7 (42.86%) |
0/6 (0.00%) |
16/72 (22.22%) |
2/6 (33.33%) |
2/6 (33.33%) |
1/6 (16.67%) |
6/29 (20.69%) |
2/8 (25.00%) |
Aspartate aminotransferase increased |
5/7 (71.43%) |
3/6 (50.00%) |
36/72 (50.00%) |
3/6 (50.00%) |
3/6 (50.00%) |
4/6 (66.67%) |
10/29 (34.48%) |
6/8 (75.00%) |
Blood bilirubin increased |
1/7 (14.29%) |
0/6 (0.00%) |
11/72 (15.28%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
4/29 (13.79%) |
2/8 (25.00%) |
CPK increased |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Cardiac troponin I increased |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
1/8 (12.50%) |
Cholesterol high |
0/7 (0.00%) |
0/6 (0.00%) |
2/72 (2.78%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
2/29 (6.90%) |
1/8 (12.50%) |
Creatinine increased |
2/7 (28.57%) |
1/6 (16.67%) |
20/72 (27.78%) |
3/6 (50.00%) |
1/6 (16.67%) |
2/6 (33.33%) |
9/29 (31.03%) |
3/8 (37.50%) |
Electrocardiogram QT corrected interval prolonged |
0/7 (0.00%) |
0/6 (0.00%) |
5/72 (6.94%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
3/29 (10.34%) |
0/8 (0.00%) |
Fibrinogen decreased |
1/7 (14.29%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
GGT increased |
1/7 (14.29%) |
0/6 (0.00%) |
5/72 (6.94%) |
1/6 (16.67%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/29 (0.00%) |
1/8 (12.50%) |
Hemoglobin increased |
2/7 (28.57%) |
0/6 (0.00%) |
2/72 (2.78%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
2/29 (6.90%) |
0/8 (0.00%) |
INR increased |
0/7 (0.00%) |
0/6 (0.00%) |
6/72 (8.33%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
4/29 (13.79%) |
2/8 (25.00%) |
Investigations - Other, |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
4/8 (50.00%) |
Investigations - Other, BICARBONATE LOW |
1/7 (14.29%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Investigations - Other, (ELEVATED CRP) |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Investigations - Other, ALT DECREASED |
1/7 (14.29%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Investigations - Other, AMYLASE DECREASED |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Investigations - Other, AMYLASE, DECREASED |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Investigations - Other, ANION GAP INCREASED |
1/7 (14.29%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Investigations - Other, Amylase Increase |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Investigations - Other, BICARB INCREASED |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Investigations - Other, BICARBONATE |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Investigations - Other, BICARBONATE SERUM LOW |
0/7 (0.00%) |
0/6 (0.00%) |
2/72 (2.78%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Investigations - Other, BLOOD LDH INCREASED |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Investigations - Other, BUN DECREASED |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Investigations - Other, BUN HIGH |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Investigations - Other, BUN INCREASED |
1/7 (14.29%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Investigations - Other, C REACTIVE PROTEIN |
0/7 (0.00%) |
0/6 (0.00%) |
6/72 (8.33%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Investigations - Other, C REACTIVE PROTEIN ELEVATED |
0/7 (0.00%) |
1/6 (16.67%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Investigations - Other, C REACTIVE PROTEIN INCREASED |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Investigations - Other, C-REACTIVE PROT |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Investigations - Other, C-REACTIVE PROTEIN |
0/7 (0.00%) |
0/6 (0.00%) |
3/72 (4.17%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Investigations - Other, C-REACTIVE PROTEIN ELEVATED |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Investigations - Other, C-REACTIVE PROTEIN INCREASED |
0/7 (0.00%) |
0/6 (0.00%) |
8/72 (11.11%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
4/29 (13.79%) |
0/8 (0.00%) |
Investigations - Other, C-REATIVE PROTEIN INCREASED |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Investigations - Other, C-Reactive Prot. |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Investigations - Other, C-Reactive prot. increase |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Investigations - Other, C-Reactive protein |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Investigations - Other, C-Reactive protein increase |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Investigations - Other, C02 LOW |
1/7 (14.29%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Investigations - Other, CARBON DIOXIDE |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Investigations - Other, CHLORIDE |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Investigations - Other, CHLORIDE DECREASED |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Investigations - Other, CHLORIDE INCREASED |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Investigations - Other, CHLORIDE LOW |
1/7 (14.29%) |
0/6 (0.00%) |
1/72 (1.39%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Investigations - Other, CO2 LOW |
1/7 (14.29%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Investigations - Other, CREATININE DECREASED |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Investigations - Other, CREATININE, DECREASED |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Investigations - Other, CRP |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Investigations - Other, CRP ELEVATED |
0/7 (0.00%) |
0/6 (0.00%) |
7/72 (9.72%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Investigations - Other, CRP HIGH |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Investigations - Other, CRP INCREASE |
0/7 (0.00%) |
0/6 (0.00%) |
2/72 (2.78%) |
0/6 (0.00%) |
0/6 (0.00%) |
3/6 (50.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Investigations - Other, CRP INCREASED |
0/7 (0.00%) |
1/6 (16.67%) |
16/72 (22.22%) |
1/6 (16.67%) |
0/6 (0.00%) |
1/6 (16.67%) |
5/29 (17.24%) |
0/8 (0.00%) |
Investigations - Other, CRP increase |
0/7 (0.00%) |
0/6 (0.00%) |
2/72 (2.78%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Investigations - Other, CRP increased |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
1/8 (12.50%) |
Investigations - Other, CRP, ELEVATED |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Investigations - Other, DECREASE CHLORIDE |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Investigations - Other, DECREASED BICARBONATE |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Investigations - Other, ELEVATED BUN |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Investigations - Other, ELEVATED C REACTIVE PROTEIN |
0/7 (0.00%) |
1/6 (16.67%) |
1/72 (1.39%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Investigations - Other, ELEVATED C-REACTIVE PROTEIN |
2/7 (28.57%) |
0/6 (0.00%) |
6/72 (8.33%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/6 (0.00%) |
3/29 (10.34%) |
0/8 (0.00%) |
Investigations - Other, ELEVATED C-REATIVE PROTEIN |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Investigations - Other, ELEVATED CRP |
1/7 (14.29%) |
2/6 (33.33%) |
9/72 (12.50%) |
1/6 (16.67%) |
1/6 (16.67%) |
0/6 (0.00%) |
8/29 (27.59%) |
0/8 (0.00%) |
Investigations - Other, ELEVATED ESR |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Investigations - Other, ELEVATED LDH |
2/7 (28.57%) |
1/6 (16.67%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
1/29 (3.45%) |
0/8 (0.00%) |
Investigations - Other, EOSINOPHIL COUNT INCREASED |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Investigations - Other, ESR INCREASED |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Investigations - Other, FREE T4 LOW |
1/7 (14.29%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Investigations - Other, GLUCOSE IN URINE |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Investigations - Other, HIGH CRP VALUE |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Investigations - Other, HYPERBILIRUBINEMIA |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Investigations - Other, HYPERCHLOREMIA |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Investigations - Other, HYPERPHOSPHATEMIA |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
2/29 (6.90%) |
0/8 (0.00%) |
Investigations - Other, HYPOCHLOREMIA |
2/7 (28.57%) |
0/6 (0.00%) |
3/72 (4.17%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Investigations - Other, HYPOURICEMIA |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Investigations - Other, Hypochloremia |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
1/8 (12.50%) |
Investigations - Other, INCREASED ANION GAP |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Investigations - Other, INCREASED C REACTIVE PROTEIN |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Investigations - Other, INCREASED C-REACTIVE PROTEIN |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Investigations - Other, INCREASED CARBON DIOXIDE LEVEL |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Investigations - Other, INCREASED CHLORIDE |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Investigations - Other, INCREASED CRP |
1/7 (14.29%) |
0/6 (0.00%) |
3/72 (4.17%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
4/29 (13.79%) |
0/8 (0.00%) |
Investigations - Other, INCREASED TSH |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Investigations - Other, INCREASED WBC |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Investigations - Other, INFLUENZA (A) |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Investigations - Other, Increased Bands |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
1/8 (12.50%) |
Investigations - Other, LDH ELEVATED |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Investigations - Other, LDH INCREASE |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Investigations - Other, LDH INCREASED |
1/7 (14.29%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Investigations - Other, LI[PASE, DECREASED |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Investigations - Other, LOW BICARB |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Investigations - Other, LOW BICARBONATE |
0/7 (0.00%) |
0/6 (0.00%) |
2/72 (2.78%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Investigations - Other, LOW C-REACTIVE PROTEIN |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Investigations - Other, LOW CO2 |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Investigations - Other, LOW VITAMIN D |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Investigations - Other, LYMPHOPENIA |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Investigations - Other, MCHC DECREASED |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Investigations - Other, NEUROPHILA |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Investigations - Other, NON FASTING GLUCOSE |
1/7 (14.29%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Investigations - Other, PHOSPHORUS INCREASED |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Investigations - Other, PLATELET COUNT INCREASED |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Investigations - Other, PT PROLONGED |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Investigations - Other, PTT SHORTENED |
1/7 (14.29%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Investigations - Other, RIGHT LOWER BACK PRESSURE |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Investigations - Other, SERUM OSMOLARITY DECEASE |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Investigations - Other, SERUM PROTEIN DECREASED |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Investigations - Other, TINGLING IN HANDS/NEURO PAIN |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Investigations - Other, TOTAL PROTEIN |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Investigations - Other, TOTAL PROTEIN DECREASED |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Investigations - Other, TSH ELEVATED |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Investigations - Other, TSH HIGH |
1/7 (14.29%) |
0/6 (0.00%) |
1/72 (1.39%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Investigations - Other, TSH INCREASED |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Investigations - Other, TSH LOW |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Investigations - Other, VIT D DEFICIENCY |
0/7 (0.00%) |
1/6 (16.67%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Investigations - Other, VITAMIN D DEFICIENCY |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Investigations - Other, Vitamin D decrease |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
1/8 (12.50%) |
Investigations - Other, lipase increase |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Lipase increased |
0/7 (0.00%) |
0/6 (0.00%) |
5/72 (6.94%) |
0/6 (0.00%) |
1/6 (16.67%) |
2/6 (33.33%) |
5/29 (17.24%) |
1/8 (12.50%) |
Lymphocyte count decreased |
5/7 (71.43%) |
3/6 (50.00%) |
37/72 (51.39%) |
3/6 (50.00%) |
2/6 (33.33%) |
2/6 (33.33%) |
17/29 (58.62%) |
7/8 (87.50%) |
Lymphocyte count increased |
0/7 (0.00%) |
1/6 (16.67%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Neutrophil count decreased |
3/7 (42.86%) |
4/6 (66.67%) |
23/72 (31.94%) |
2/6 (33.33%) |
3/6 (50.00%) |
0/6 (0.00%) |
8/29 (27.59%) |
4/8 (50.00%) |
Pancreatic enzymes decreased |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Platelet count decreased |
4/7 (57.14%) |
4/6 (66.67%) |
37/72 (51.39%) |
3/6 (50.00%) |
3/6 (50.00%) |
2/6 (33.33%) |
10/29 (34.48%) |
2/8 (25.00%) |
Serum amylase increased |
0/7 (0.00%) |
0/6 (0.00%) |
5/72 (6.94%) |
1/6 (16.67%) |
2/6 (33.33%) |
3/6 (50.00%) |
1/29 (3.45%) |
1/8 (12.50%) |
Weight gain |
2/7 (28.57%) |
0/6 (0.00%) |
3/72 (4.17%) |
1/6 (16.67%) |
0/6 (0.00%) |
1/6 (16.67%) |
1/29 (3.45%) |
2/8 (25.00%) |
Weight loss |
1/7 (14.29%) |
3/6 (50.00%) |
14/72 (19.44%) |
3/6 (50.00%) |
2/6 (33.33%) |
2/6 (33.33%) |
10/29 (34.48%) |
3/8 (37.50%) |
White blood cell decreased |
4/7 (57.14%) |
4/6 (66.67%) |
40/72 (55.56%) |
2/6 (33.33%) |
3/6 (50.00%) |
1/6 (16.67%) |
11/29 (37.93%) |
4/8 (50.00%) |
Metabolism and nutrition disorders |
|
|
|
|
|
|
|
|
Acidosis |
0/7 (0.00%) |
1/6 (16.67%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Alkalosis |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
2/29 (6.90%) |
0/8 (0.00%) |
Anorexia |
3/7 (42.86%) |
4/6 (66.67%) |
28/72 (38.89%) |
1/6 (16.67%) |
4/6 (66.67%) |
2/6 (33.33%) |
17/29 (58.62%) |
5/8 (62.50%) |
Dehydration |
1/7 (14.29%) |
0/6 (0.00%) |
5/72 (6.94%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/6 (0.00%) |
5/29 (17.24%) |
1/8 (12.50%) |
Hypercalcemia |
0/7 (0.00%) |
1/6 (16.67%) |
8/72 (11.11%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
4/29 (13.79%) |
0/8 (0.00%) |
Hyperglycemia |
3/7 (42.86%) |
3/6 (50.00%) |
29/72 (40.28%) |
3/6 (50.00%) |
3/6 (50.00%) |
3/6 (50.00%) |
11/29 (37.93%) |
7/8 (87.50%) |
Hyperkalemia |
1/7 (14.29%) |
0/6 (0.00%) |
13/72 (18.06%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
5/29 (17.24%) |
1/8 (12.50%) |
Hypermagnesemia |
1/7 (14.29%) |
1/6 (16.67%) |
13/72 (18.06%) |
1/6 (16.67%) |
2/6 (33.33%) |
0/6 (0.00%) |
4/29 (13.79%) |
0/8 (0.00%) |
Hypernatremia |
0/7 (0.00%) |
0/6 (0.00%) |
8/72 (11.11%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
3/29 (10.34%) |
0/8 (0.00%) |
Hypertriglyceridemia |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
2/6 (33.33%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
1/8 (12.50%) |
Hyperuricemia |
0/7 (0.00%) |
0/6 (0.00%) |
4/72 (5.56%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/29 (0.00%) |
1/8 (12.50%) |
Hypoalbuminemia |
2/7 (28.57%) |
4/6 (66.67%) |
43/72 (59.72%) |
3/6 (50.00%) |
3/6 (50.00%) |
5/6 (83.33%) |
14/29 (48.28%) |
6/8 (75.00%) |
Hypocalcemia |
4/7 (57.14%) |
3/6 (50.00%) |
36/72 (50.00%) |
3/6 (50.00%) |
3/6 (50.00%) |
2/6 (33.33%) |
9/29 (31.03%) |
6/8 (75.00%) |
Hypoglycemia |
1/7 (14.29%) |
1/6 (16.67%) |
10/72 (13.89%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
2/29 (6.90%) |
2/8 (25.00%) |
Hypokalemia |
3/7 (42.86%) |
3/6 (50.00%) |
22/72 (30.56%) |
3/6 (50.00%) |
2/6 (33.33%) |
1/6 (16.67%) |
10/29 (34.48%) |
3/8 (37.50%) |
Hypomagnesemia |
0/7 (0.00%) |
0/6 (0.00%) |
25/72 (34.72%) |
0/6 (0.00%) |
1/6 (16.67%) |
1/6 (16.67%) |
7/29 (24.14%) |
4/8 (50.00%) |
Hyponatremia |
2/7 (28.57%) |
4/6 (66.67%) |
40/72 (55.56%) |
4/6 (66.67%) |
2/6 (33.33%) |
3/6 (50.00%) |
13/29 (44.83%) |
4/8 (50.00%) |
Hypophosphatemia |
1/7 (14.29%) |
3/6 (50.00%) |
28/72 (38.89%) |
2/6 (33.33%) |
1/6 (16.67%) |
2/6 (33.33%) |
10/29 (34.48%) |
3/8 (37.50%) |
Metabolism and nutrition disorders - Other, BICARBONATE DECREASE |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Metabolism and nutrition disorders - Other, CRP ELEVATED |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Metabolism and nutrition disorders - Other, DECREASED CARBON DIOXIDE (CO2), |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Metabolism and nutrition disorders - Other, DECREASED PROTEIN |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Metabolism and nutrition disorders - Other, ELEVATED BICARBONATE |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Metabolism and nutrition disorders - Other, ELEVATED TSH |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Metabolism and nutrition disorders - Other, HYPOCHLOREMIA |
1/7 (14.29%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Obesity |
1/7 (14.29%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Musculoskeletal and connective tissue disorders |
|
|
|
|
|
|
|
|
Arthralgia |
0/7 (0.00%) |
1/6 (16.67%) |
6/72 (8.33%) |
0/6 (0.00%) |
3/6 (50.00%) |
0/6 (0.00%) |
2/29 (6.90%) |
3/8 (37.50%) |
Arthritis |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Back pain |
1/7 (14.29%) |
1/6 (16.67%) |
22/72 (30.56%) |
1/6 (16.67%) |
2/6 (33.33%) |
1/6 (16.67%) |
11/29 (37.93%) |
4/8 (50.00%) |
Bone pain |
0/7 (0.00%) |
0/6 (0.00%) |
5/72 (6.94%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
1/8 (12.50%) |
Buttock pain |
0/7 (0.00%) |
1/6 (16.67%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Chest wall pain |
0/7 (0.00%) |
0/6 (0.00%) |
3/72 (4.17%) |
0/6 (0.00%) |
0/6 (0.00%) |
2/6 (33.33%) |
0/29 (0.00%) |
0/8 (0.00%) |
Flank pain |
0/7 (0.00%) |
0/6 (0.00%) |
5/72 (6.94%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
2/29 (6.90%) |
1/8 (12.50%) |
Generalized muscle weakness |
0/7 (0.00%) |
0/6 (0.00%) |
6/72 (8.33%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
6/29 (20.69%) |
1/8 (12.50%) |
Joint effusion |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Joint range of motion decreased |
2/7 (28.57%) |
0/6 (0.00%) |
6/72 (8.33%) |
2/6 (33.33%) |
0/6 (0.00%) |
0/6 (0.00%) |
8/29 (27.59%) |
0/8 (0.00%) |
Joint range of motion decreased cervical spine |
0/7 (0.00%) |
1/6 (16.67%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Kyphosis |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Muscle weakness left-sided |
0/7 (0.00%) |
1/6 (16.67%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Muscle weakness lower limb |
0/7 (0.00%) |
0/6 (0.00%) |
5/72 (6.94%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
3/29 (10.34%) |
1/8 (12.50%) |
Muscle weakness upper limb |
1/7 (14.29%) |
0/6 (0.00%) |
2/72 (2.78%) |
2/6 (33.33%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Musculoskeletal and connective tissue disorder - Other, AMBULATES WITH LIMP |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Musculoskeletal and connective tissue disorder - Other, ANKLE PAIN |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Musculoskeletal and connective tissue disorder - Other, CHEST WALL MASS |
1/7 (14.29%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Musculoskeletal and connective tissue disorder - Other, CRACKING/SQUEAKING |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Musculoskeletal and connective tissue disorder - Other, DECONDITIONING |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Musculoskeletal and connective tissue disorder - Other, HAND AND LEG CRAMPING |
1/7 (14.29%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Musculoskeletal and connective tissue disorder - Other, HEAD - LARGE INDENTION IN OCCIPITAL SCALP |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Musculoskeletal and connective tissue disorder - Other, HIP PAIN |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Musculoskeletal and connective tissue disorder - Other, LIMBS MUSCLE CRAMPING |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Musculoskeletal and connective tissue disorder - Other, MUSCLE SPASMS |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
2/29 (6.90%) |
0/8 (0.00%) |
Musculoskeletal and connective tissue disorder - Other, SHOULDER PAIN |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Musculoskeletal and connective tissue disorder - Other, SWELLING |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Musculoskeletal and connective tissue disorder - Other, SWELLING OF LT MID BACK |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Musculoskeletal deformity |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Myalgia |
0/7 (0.00%) |
0/6 (0.00%) |
5/72 (6.94%) |
0/6 (0.00%) |
2/6 (33.33%) |
1/6 (16.67%) |
3/29 (10.34%) |
2/8 (25.00%) |
Neck pain |
1/7 (14.29%) |
2/6 (33.33%) |
4/72 (5.56%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
2/29 (6.90%) |
1/8 (12.50%) |
Pain in extremity |
1/7 (14.29%) |
4/6 (66.67%) |
26/72 (36.11%) |
3/6 (50.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
15/29 (51.72%) |
1/8 (12.50%) |
Scoliosis |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
1/6 (16.67%) |
0/29 (0.00%) |
0/8 (0.00%) |
Trismus |
0/7 (0.00%) |
0/6 (0.00%) |
2/72 (2.78%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
|
|
|
|
|
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, INTRATUMOR HEMORRHAGE |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, TUMOR SWELLING, LEFT FO |
1/7 (14.29%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, TUMOR SWELLING: LEFT TH |
1/7 (14.29%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Tumor pain |
2/7 (28.57%) |
1/6 (16.67%) |
9/72 (12.50%) |
2/6 (33.33%) |
0/6 (0.00%) |
1/6 (16.67%) |
4/29 (13.79%) |
1/8 (12.50%) |
Nervous system disorders |
|
|
|
|
|
|
|
|
Akathisia |
0/7 (0.00%) |
1/6 (16.67%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Amnesia |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
1/8 (12.50%) |
Cognitive disturbance |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Concentration impairment |
0/7 (0.00%) |
0/6 (0.00%) |
3/72 (4.17%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Depressed level of consciousness |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
1/29 (3.45%) |
0/8 (0.00%) |
Dizziness |
1/7 (14.29%) |
1/6 (16.67%) |
7/72 (9.72%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
2/8 (25.00%) |
Dysarthria |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Dysgeusia |
0/7 (0.00%) |
1/6 (16.67%) |
3/72 (4.17%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Encephalopathy |
0/7 (0.00%) |
1/6 (16.67%) |
0/72 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Facial nerve disorder |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
2/29 (6.90%) |
0/8 (0.00%) |
Headache |
3/7 (42.86%) |
1/6 (16.67%) |
26/72 (36.11%) |
4/6 (66.67%) |
4/6 (66.67%) |
2/6 (33.33%) |
11/29 (37.93%) |
3/8 (37.50%) |
Hypersomnia |
1/7 (14.29%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Hypoglossal nerve disorder |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Lethargy |
0/7 (0.00%) |
1/6 (16.67%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Movements involuntary |
0/7 (0.00%) |
1/6 (16.67%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Nervous system disorders - Other, DECREASED REFLEXES |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Nervous system disorders - Other, HYPERALGESIA |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/29 (0.00%) |
0/8 (0.00%) |
Nervous system disorders - Other, LIGHT-HEADED |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Nervous system disorders - Other, MENTAL STATUS CHANGES |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Nervous system disorders - Other, PARAPLEGIC IN LEGS |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Nervous system disorders - Other, SPINAL CORD COMPRESSION |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Nervous system disorders - Other, WEARS GLASSES |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Neuralgia |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
2/29 (6.90%) |
0/8 (0.00%) |
Nystagmus |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Oculomotor nerve disorder |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Paresthesia |
0/7 (0.00%) |
0/6 (0.00%) |
5/72 (6.94%) |
1/6 (16.67%) |
1/6 (16.67%) |
1/6 (16.67%) |
2/29 (6.90%) |
2/8 (25.00%) |
Peripheral motor neuropathy |
0/7 (0.00%) |
0/6 (0.00%) |
2/72 (2.78%) |
1/6 (16.67%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Peripheral sensory neuropathy |
0/7 (0.00%) |
3/6 (50.00%) |
9/72 (12.50%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
5/29 (17.24%) |
2/8 (25.00%) |
Phantom pain |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
1/29 (3.45%) |
0/8 (0.00%) |
Presyncope |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
1/8 (12.50%) |
Radiculitis |
0/7 (0.00%) |
1/6 (16.67%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Seizure |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
1/8 (12.50%) |
Somnolence |
0/7 (0.00%) |
2/6 (33.33%) |
6/72 (8.33%) |
1/6 (16.67%) |
0/6 (0.00%) |
1/6 (16.67%) |
3/29 (10.34%) |
0/8 (0.00%) |
Tremor |
1/7 (14.29%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
1/8 (12.50%) |
Trigeminal nerve disorder |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Psychiatric disorders |
|
|
|
|
|
|
|
|
Agitation |
0/7 (0.00%) |
2/6 (33.33%) |
2/72 (2.78%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
2/29 (6.90%) |
2/8 (25.00%) |
Anxiety |
3/7 (42.86%) |
1/6 (16.67%) |
18/72 (25.00%) |
2/6 (33.33%) |
2/6 (33.33%) |
1/6 (16.67%) |
14/29 (48.28%) |
4/8 (50.00%) |
Confusion |
0/7 (0.00%) |
1/6 (16.67%) |
3/72 (4.17%) |
0/6 (0.00%) |
0/6 (0.00%) |
2/6 (33.33%) |
2/29 (6.90%) |
1/8 (12.50%) |
Delirium |
0/7 (0.00%) |
1/6 (16.67%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
2/29 (6.90%) |
0/8 (0.00%) |
Depression |
1/7 (14.29%) |
1/6 (16.67%) |
12/72 (16.67%) |
0/6 (0.00%) |
2/6 (33.33%) |
1/6 (16.67%) |
6/29 (20.69%) |
2/8 (25.00%) |
Euphoria |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Hallucinations |
0/7 (0.00%) |
1/6 (16.67%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Insomnia |
0/7 (0.00%) |
0/6 (0.00%) |
15/72 (20.83%) |
0/6 (0.00%) |
0/6 (0.00%) |
2/6 (33.33%) |
8/29 (27.59%) |
3/8 (37.50%) |
Personality change |
1/7 (14.29%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Psychiatric disorders - Other, ADHD |
0/7 (0.00%) |
1/6 (16.67%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Psychiatric disorders - Other, DYSPHORIA |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Psychiatric disorders - Other, EXCORIATION/SKIN PICKING |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Psychiatric disorders - Other, HX OF ADD |
1/7 (14.29%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Psychiatric disorders - Other, SPEECH/LANGUAGE DISORDER |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Restlessness |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Renal and urinary disorders |
|
|
|
|
|
|
|
|
Acute kidney injury |
0/7 (0.00%) |
0/6 (0.00%) |
3/72 (4.17%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
2/29 (6.90%) |
0/8 (0.00%) |
Bladder spasm |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Hematuria |
5/7 (71.43%) |
1/6 (16.67%) |
15/72 (20.83%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
5/29 (17.24%) |
3/8 (37.50%) |
Hemoglobinuria |
0/7 (0.00%) |
0/6 (0.00%) |
2/72 (2.78%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Proteinuria |
1/7 (14.29%) |
0/6 (0.00%) |
20/72 (27.78%) |
1/6 (16.67%) |
5/6 (83.33%) |
4/6 (66.67%) |
11/29 (37.93%) |
4/8 (50.00%) |
Renal and urinary disorders - Other, 1 + KETONES IN URINE |
1/7 (14.29%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Renal and urinary disorders - Other, DYSURIA |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Renal and urinary disorders - Other, FANCONI PROXIMAL TUBULE RENAL DISEASE. |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Renal and urinary disorders - Other, GLUCOSURIA |
0/7 (0.00%) |
0/6 (0.00%) |
2/72 (2.78%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Renal and urinary disorders - Other, HYDRONEPHROSIS |
0/7 (0.00%) |
0/6 (0.00%) |
3/72 (4.17%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Renal and urinary disorders - Other, HYDRONEPHROSIS W/ PELVOCALICETASIS |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/29 (0.00%) |
0/8 (0.00%) |
Renal and urinary disorders - Other, HYDRONEPHROSIS/URINARY CATHETERIZATION |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Renal and urinary disorders - Other, KETONURIA |
1/7 (14.29%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Renal and urinary disorders - Other, MUCOUS IN URINE |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Renal and urinary disorders - Other, Nephrostomy tube bleeding |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Renal and urinary disorders - Other, OLIGURIA |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Renal and urinary disorders - Other, TRACE URINE PROTEIN |
1/7 (14.29%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Renal and urinary disorders - Other, URINARY HESITANCY |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Renal and urinary disorders - Other, URINE GLUCOSE |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Renal and urinary disorders - Other, URINE MUCUS |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Renal and urinary disorders - Other, URINE RBCS |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Renal and urinary disorders - Other, URINE URBILINOGEN |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Renal and urinary disorders - Other, URINE WBCS |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Urinary frequency |
0/7 (0.00%) |
0/6 (0.00%) |
5/72 (6.94%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Urinary incontinence |
0/7 (0.00%) |
1/6 (16.67%) |
5/72 (6.94%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
4/29 (13.79%) |
1/8 (12.50%) |
Urinary retention |
0/7 (0.00%) |
0/6 (0.00%) |
9/72 (12.50%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
2/29 (6.90%) |
1/8 (12.50%) |
Urinary tract obstruction |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Urinary tract pain |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
1/29 (3.45%) |
0/8 (0.00%) |
Urinary urgency |
0/7 (0.00%) |
0/6 (0.00%) |
4/72 (5.56%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
2/8 (25.00%) |
Urine discoloration |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
2/29 (6.90%) |
0/8 (0.00%) |
Reproductive system and breast disorders |
|
|
|
|
|
|
|
|
Ejaculation disorder |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
1/8 (12.50%) |
Erectile dysfunction |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Genital edema |
0/7 (0.00%) |
0/6 (0.00%) |
2/72 (2.78%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
2/29 (6.90%) |
0/8 (0.00%) |
Gynecomastia |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Menorrhagia |
0/7 (0.00%) |
0/6 (0.00%) |
2/72 (2.78%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Ovulation pain |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Pelvic pain |
1/7 (14.29%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
2/29 (6.90%) |
0/8 (0.00%) |
Penile pain |
0/7 (0.00%) |
0/6 (0.00%) |
2/72 (2.78%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Reproductive system and breast disorders - Other, |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
1/8 (12.50%) |
Reproductive system and breast disorders - Other, PRIMARY OVARIAN FAILURE |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Scrotal pain |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Testicular pain |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Vaginal pain |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Respiratory, thoracic and mediastinal disorders |
|
|
|
|
|
|
|
|
Allergic rhinitis |
1/7 (14.29%) |
1/6 (16.67%) |
6/72 (8.33%) |
2/6 (33.33%) |
0/6 (0.00%) |
1/6 (16.67%) |
2/29 (6.90%) |
1/8 (12.50%) |
Aspiration |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Atelectasis |
1/7 (14.29%) |
0/6 (0.00%) |
3/72 (4.17%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
4/29 (13.79%) |
0/8 (0.00%) |
Bronchial obstruction |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Bronchopulmonary hemorrhage |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Cough |
5/7 (71.43%) |
4/6 (66.67%) |
36/72 (50.00%) |
3/6 (50.00%) |
3/6 (50.00%) |
2/6 (33.33%) |
15/29 (51.72%) |
4/8 (50.00%) |
Dyspnea |
3/7 (42.86%) |
1/6 (16.67%) |
13/72 (18.06%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
4/29 (13.79%) |
4/8 (50.00%) |
Epistaxis |
3/7 (42.86%) |
1/6 (16.67%) |
8/72 (11.11%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
3/29 (10.34%) |
1/8 (12.50%) |
Hiccups |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
3/29 (10.34%) |
0/8 (0.00%) |
Hoarseness |
0/7 (0.00%) |
1/6 (16.67%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
1/8 (12.50%) |
Hypoxia |
2/7 (28.57%) |
0/6 (0.00%) |
3/72 (4.17%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
1/8 (12.50%) |
Laryngeal hemorrhage |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Nasal congestion |
2/7 (28.57%) |
1/6 (16.67%) |
16/72 (22.22%) |
1/6 (16.67%) |
1/6 (16.67%) |
0/6 (0.00%) |
7/29 (24.14%) |
3/8 (37.50%) |
Pharyngolaryngeal pain |
0/7 (0.00%) |
0/6 (0.00%) |
2/72 (2.78%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Pleural effusion |
1/7 (14.29%) |
0/6 (0.00%) |
11/72 (15.28%) |
2/6 (33.33%) |
1/6 (16.67%) |
0/6 (0.00%) |
10/29 (34.48%) |
1/8 (12.50%) |
Pleural hemorrhage |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Pleuritic pain |
0/7 (0.00%) |
0/6 (0.00%) |
2/72 (2.78%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
3/29 (10.34%) |
0/8 (0.00%) |
Pneumonitis |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
2/29 (6.90%) |
0/8 (0.00%) |
Pneumothorax |
1/7 (14.29%) |
1/6 (16.67%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Postnasal drip |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
3/29 (10.34%) |
0/8 (0.00%) |
Productive cough |
0/7 (0.00%) |
0/6 (0.00%) |
6/72 (8.33%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/6 (0.00%) |
4/29 (13.79%) |
0/8 (0.00%) |
Pulmonary hypertension |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Respiratory, thoracic and mediastinal disorders - Other, ASTHMA |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Respiratory, thoracic and mediastinal disorders - Other, BILATERAL AIRSPACE DISEASE |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Respiratory, thoracic and mediastinal disorders - Other, BRADYPNEA |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Respiratory, thoracic and mediastinal disorders - Other, BURNING NOSTRILS |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Respiratory, thoracic and mediastinal disorders - Other, Congestion |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
1/8 (12.50%) |
Respiratory, thoracic and mediastinal disorders - Other, DRY, SCRATCHY THROAT |
1/7 (14.29%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Respiratory, thoracic and mediastinal disorders - Other, HEMOPTYSIS |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Respiratory, thoracic and mediastinal disorders - Other, INCREASED WORK OF BREATHING |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Respiratory, thoracic and mediastinal disorders - Other, INTERMITTENT HEMOPTYSIS |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Respiratory, thoracic and mediastinal disorders - Other, RESPIRATORY DISTRESS |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Respiratory, thoracic and mediastinal disorders - Other, RHINORRHEA |
0/7 (0.00%) |
0/6 (0.00%) |
2/72 (2.78%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
2/29 (6.90%) |
0/8 (0.00%) |
Respiratory, thoracic and mediastinal disorders - Other, RUNNY NOSE |
1/7 (14.29%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Respiratory, thoracic and mediastinal disorders - Other, TACHYPNEA |
1/7 (14.29%) |
0/6 (0.00%) |
7/72 (9.72%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Respiratory, thoracic and mediastinal disorders - Other, Tachypnea |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
1/8 (12.50%) |
Sinus pain |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
1/8 (12.50%) |
Sleep apnea |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
1/8 (12.50%) |
Sneezing |
0/7 (0.00%) |
0/6 (0.00%) |
2/72 (2.78%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Sore throat |
1/7 (14.29%) |
1/6 (16.67%) |
8/72 (11.11%) |
0/6 (0.00%) |
1/6 (16.67%) |
1/6 (16.67%) |
6/29 (20.69%) |
2/8 (25.00%) |
Voice alteration |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Wheezing |
1/7 (14.29%) |
0/6 (0.00%) |
6/72 (8.33%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
4/29 (13.79%) |
0/8 (0.00%) |
Skin and subcutaneous tissue disorders |
|
|
|
|
|
|
|
|
Alopecia |
3/7 (42.86%) |
1/6 (16.67%) |
24/72 (33.33%) |
1/6 (16.67%) |
0/6 (0.00%) |
2/6 (33.33%) |
10/29 (34.48%) |
2/8 (25.00%) |
Bullous dermatitis |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Dry skin |
2/7 (28.57%) |
0/6 (0.00%) |
8/72 (11.11%) |
2/6 (33.33%) |
0/6 (0.00%) |
0/6 (0.00%) |
5/29 (17.24%) |
1/8 (12.50%) |
Erythema multiforme |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Hyperhidrosis |
1/7 (14.29%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Hypohidrosis |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Nail discoloration |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Pain of skin |
0/7 (0.00%) |
0/6 (0.00%) |
2/72 (2.78%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
1/8 (12.50%) |
Palmar-plantar erythrodysesthesia syndrome |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Periorbital edema |
2/7 (28.57%) |
0/6 (0.00%) |
2/72 (2.78%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Pruritus |
3/7 (42.86%) |
2/6 (33.33%) |
13/72 (18.06%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
4/29 (13.79%) |
2/8 (25.00%) |
Purpura |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Rash acneiform |
0/7 (0.00%) |
0/6 (0.00%) |
5/72 (6.94%) |
2/6 (33.33%) |
1/6 (16.67%) |
0/6 (0.00%) |
1/29 (3.45%) |
2/8 (25.00%) |
Rash maculo-papular |
3/7 (42.86%) |
2/6 (33.33%) |
12/72 (16.67%) |
3/6 (50.00%) |
2/6 (33.33%) |
0/6 (0.00%) |
3/29 (10.34%) |
1/8 (12.50%) |
Skin and subcutaneous tissue disorders - Other, ABRASION TO FACE |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Skin and subcutaneous tissue disorders - Other, ABRASIONS |
1/7 (14.29%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Skin and subcutaneous tissue disorders - Other, BLISTERS |
1/7 (14.29%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Skin and subcutaneous tissue disorders - Other, BUG BITES |
1/7 (14.29%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Skin and subcutaneous tissue disorders - Other, BUG BITES ON SCALP. |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Skin and subcutaneous tissue disorders - Other, Blister |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Skin and subcutaneous tissue disorders - Other, CAFE AU LAIT ON ABDOMEN |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Skin and subcutaneous tissue disorders - Other, CHAPPED LIPS |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Skin and subcutaneous tissue disorders - Other, CIRCULAR, FLAT AREA WITH REDNESS ON BACK |
0/7 (0.00%) |
1/6 (16.67%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Skin and subcutaneous tissue disorders - Other, CONTACT DERMATITIS |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/29 (0.00%) |
0/8 (0.00%) |
Skin and subcutaneous tissue disorders - Other, DARK UNDER-EYE CIRCLES |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Skin and subcutaneous tissue disorders - Other, DERMATITIS |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Skin and subcutaneous tissue disorders - Other, DESQUAMATION |
1/7 (14.29%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Skin and subcutaneous tissue disorders - Other, DIAPER DERMATITIS |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Skin and subcutaneous tissue disorders - Other, DRY LIPS |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Skin and subcutaneous tissue disorders - Other, ERYTHEMA |
0/7 (0.00%) |
0/6 (0.00%) |
2/72 (2.78%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Skin and subcutaneous tissue disorders - Other, ERYTHEMA ON R ANTECUBITAL |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Skin and subcutaneous tissue disorders - Other, ERYTHEMA RIGHT HIP |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Skin and subcutaneous tissue disorders - Other, ERYTHEMATOUS MACULAR RASH |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Skin and subcutaneous tissue disorders - Other, ERYTHEMATOUS RASH |
1/7 (14.29%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Skin and subcutaneous tissue disorders - Other, ERYTHEMATOUS SPOT ON PENIS |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Skin and subcutaneous tissue disorders - Other, ERYTHEME AROUND EYELIDS |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Skin and subcutaneous tissue disorders - Other, EXCORIATIONS |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Skin and subcutaneous tissue disorders - Other, FAINT ERYTHEMA |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Skin and subcutaneous tissue disorders - Other, FEW SCATTERED INSECT BITES ON FOREHEAD. |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Skin and subcutaneous tissue disorders - Other, INSECT BITES |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Skin and subcutaneous tissue disorders - Other, ITCHING |
1/7 (14.29%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Skin and subcutaneous tissue disorders - Other, LESION ON UPPER LIP |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Skin and subcutaneous tissue disorders - Other, MILD DIFFUSE REDNESS ARMS |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Skin and subcutaneous tissue disorders - Other, MILD ERYTHEMIA |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Skin and subcutaneous tissue disorders - Other, NEVUS FLAMMEUS ON R FACE & OROPHARYNX |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Skin and subcutaneous tissue disorders - Other, NEVUS LESIONS |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Skin and subcutaneous tissue disorders - Other, NON-RAISED, NON-PRURITIC RASH TO CHEEKS |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/29 (0.00%) |
0/8 (0.00%) |
Skin and subcutaneous tissue disorders - Other, ORAL THRUSH |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/29 (0.00%) |
0/8 (0.00%) |
Skin and subcutaneous tissue disorders - Other, PAPULAR RASH |
1/7 (14.29%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Skin and subcutaneous tissue disorders - Other, PIMPLES |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Skin and subcutaneous tissue disorders - Other, RASH |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Skin and subcutaneous tissue disorders - Other, Rash |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Skin and subcutaneous tissue disorders - Other, SEVERAL PETECHIAE. |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Skin and subcutaneous tissue disorders - Other, SKIN LESION UNDER NOSE |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Skin and subcutaneous tissue disorders - Other, SLIGHT ERYTHEMA OF SKIN OVERLYING RIGHT AXILLARY MAS |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Skin and subcutaneous tissue disorders - Other, STASIS DERMATITIS |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Skin and subcutaneous tissue disorders - Other, STRIAE |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Skin and subcutaneous tissue disorders - Other, TINY PAPULES ON SHOULDER AND UPPER ABDOMEN |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Skin and subcutaneous tissue disorders - Other, UNKNOWN SKIN LESIONS |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Skin and subcutaneous tissue disorders - Other, WARTS |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Skin and subcutaneous tissue disorders - Other, WHITE BLOTCHES ON ABDOMEN |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Skin atrophy |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Skin hyperpigmentation |
1/7 (14.29%) |
0/6 (0.00%) |
5/72 (6.94%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
3/29 (10.34%) |
0/8 (0.00%) |
Skin hypopigmentation |
0/7 (0.00%) |
0/6 (0.00%) |
4/72 (5.56%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Skin ulceration |
0/7 (0.00%) |
1/6 (16.67%) |
3/72 (4.17%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Urticaria |
1/7 (14.29%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
0/8 (0.00%) |
Vascular disorders |
|
|
|
|
|
|
|
|
Flushing |
0/7 (0.00%) |
0/6 (0.00%) |
1/72 (1.39%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
1/8 (12.50%) |
Hot flashes |
0/7 (0.00%) |
0/6 (0.00%) |
3/72 (4.17%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Hypertension |
4/7 (57.14%) |
3/6 (50.00%) |
17/72 (23.61%) |
2/6 (33.33%) |
1/6 (16.67%) |
1/6 (16.67%) |
13/29 (44.83%) |
2/8 (25.00%) |
Hypotension |
1/7 (14.29%) |
0/6 (0.00%) |
14/72 (19.44%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
8/29 (27.59%) |
3/8 (37.50%) |
Lymphedema |
0/7 (0.00%) |
0/6 (0.00%) |
3/72 (4.17%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/29 (3.45%) |
0/8 (0.00%) |
Thromboembolic event |
0/7 (0.00%) |
0/6 (0.00%) |
4/72 (5.56%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/29 (0.00%) |
1/8 (12.50%) |
Vascular disorders - Other, |
0/7 (0.00%) |
0/6 (0.00%) |
0/72 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/29 (0.00%) |
1/8 (12.50%) |
Indicates events were collected by systematic assessment
|