Time Frame |
[Not Specified]
|
Adverse Event Reporting Description |
[Not Specified]
|
|
Arm/Group Title
|
Guided AC Sensitive
|
Guided TC Sensitive
|
Guided AC Non-sensitive
|
Guided TC Non-Sensitive
|
Non-guided AC
|
Non-guided TC
|
Screen Failures
|
Arm/Group Description |
Genomically-guided >60% probability...
|
Genomically-guided treatment >60% p...
|
Genomics guided treatment <60% prob...
|
Genomics guided treatment <60% prob...
|
Non-genomics guided treatment; rand...
|
Non-genomics guided treatment; rand...
|
Screen failures constitute patients...
|
Arm/Group Description |
Genomically-guided >60% probability of response to AC
AC: Doxorubicin 60 mg/m² and Cyclophosphamide 600 mg/m² (AC) every 3 weeks for 4 cycles as neoadjuvant therapy
|
Genomically-guided treatment >60% probability of response to TC
TC: Docetaxel 75 mg/m² and Cyclophosphamide 600 mg/m² (TC) every 3 weeks for 4 cycles as neoadjuvant therapy
|
Genomics guided treatment <60% probability of response to both AC and TC; randomized to AC
AC: Doxorubicin 60 mg/m² and Cyclophosphamide 600 mg/m² (AC) every 3 weeks for 4 cycles as neoadjuvant therapy
|
Genomics guided treatment <60% probability of response to both AC and TC; randomized to TC
TC: Docetaxel 75 mg/m² and Cyclophosphamide 600 mg/m² (TC) every 3 weeks for 4 cycles as neoadjuvant therapy
|
Non-genomics guided treatment; randomized to AC
AC: Doxorubicin 60 mg/m² and Cyclophosphamide 600 mg/m² (AC) every 3 weeks for 4 cycles as neoadjuvant therapy
|
Non-genomics guided treatment; randomized to TC
TC: Docetaxel 75 mg/m² and Cyclophosphamide 600 mg/m² (TC) every 3 weeks for 4 cycles as neoadjuvant therapy
|
Screen failures constitute patients who were registered to the study but were not assigned treatment for various reasons.
|
|
|
Guided AC Sensitive
|
Guided TC Sensitive
|
Guided AC Non-sensitive
|
Guided TC Non-Sensitive
|
Non-guided AC
|
Non-guided TC
|
Screen Failures
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
--/-- |
--/-- |
--/-- |
--/-- |
--/-- |
--/-- |
--/-- |
|
|
Guided AC Sensitive
|
Guided TC Sensitive
|
Guided AC Non-sensitive
|
Guided TC Non-Sensitive
|
Non-guided AC
|
Non-guided TC
|
Screen Failures
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
2/6 (33.33%) |
0/7 (0.00%) |
3/6 (50.00%) |
2/6 (33.33%) |
1/6 (16.67%) |
2/7 (28.57%) |
1/18 (5.56%) |
Blood and lymphatic system disorders |
|
|
|
|
|
|
|
Anemia |
0/6 (0.00%) |
0/7 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/7 (14.29%) |
1/18 (5.56%) |
Febrile neutropenia |
1/6 (16.67%) |
0/7 (0.00%) |
1/6 (16.67%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/18 (0.00%) |
Ear and labyrinth disorders |
|
|
|
|
|
|
|
Ear and labyrinth disorders: ear complete hearing loss |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/7 (0.00%) |
0/18 (0.00%) |
Gastrointestinal disorders |
|
|
|
|
|
|
|
Abdominal pain |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/18 (0.00%) |
Immune system disorders |
|
|
|
|
|
|
|
Allergic reaction |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/7 (14.29%) |
0/18 (0.00%) |
Infections and infestations |
|
|
|
|
|
|
|
Infections and infestations: Infection with neutrophils: Abdomen NOS |
0/6 (0.00%) |
0/7 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/18 (0.00%) |
Infections and infestations: UTI |
1/6 (16.67%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/18 (0.00%) |
Investigations |
|
|
|
|
|
|
|
Neutrophil count decreased |
2/6 (33.33%) |
0/7 (0.00%) |
2/6 (33.33%) |
1/6 (16.67%) |
0/6 (0.00%) |
1/7 (14.29%) |
0/18 (0.00%) |
White blood cell decreased |
1/6 (16.67%) |
0/7 (0.00%) |
1/6 (16.67%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/18 (0.00%) |
Indicates events were collected by systematic assessment
Term from vocabulary, CTCAE (4.0)
|
|
Frequency Threshold for Reporting Other Adverse Events
|
0%
|
|
Guided AC Sensitive
|
Guided TC Sensitive
|
Guided AC Non-sensitive
|
Guided TC Non-Sensitive
|
Non-guided AC
|
Non-guided TC
|
Screen Failures
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
6/6 (100.00%) |
7/7 (100.00%) |
6/6 (100.00%) |
6/6 (100.00%) |
6/6 (100.00%) |
7/7 (100.00%) |
1/18 (5.56%) |
Blood and lymphatic system disorders |
|
|
|
|
|
|
|
Anemia |
3/6 (50.00%) |
3/7 (42.86%) |
1/6 (16.67%) |
2/6 (33.33%) |
1/6 (16.67%) |
3/7 (42.86%) |
0/18 (0.00%) |
Lymph node pain |
2/6 (33.33%) |
0/7 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
1/6 (16.67%) |
1/7 (14.29%) |
0/18 (0.00%) |
Cardiac disorders |
|
|
|
|
|
|
|
Cardiac disorders: Tachycardia |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/7 (14.29%) |
0/18 (0.00%) |
Cardiac disorders: palpitations |
0/6 (0.00%) |
1/7 (14.29%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/18 (0.00%) |
Palpitations |
0/6 (0.00%) |
0/7 (0.00%) |
1/6 (16.67%) |
1/6 (16.67%) |
2/6 (33.33%) |
1/7 (14.29%) |
0/18 (0.00%) |
Ear and labyrinth disorders |
|
|
|
|
|
|
|
External ear inflammation |
0/6 (0.00%) |
0/7 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/18 (0.00%) |
Tinnitus |
0/6 (0.00%) |
0/7 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/7 (14.29%) |
0/18 (0.00%) |
Eye disorders |
|
|
|
|
|
|
|
Blurred vision |
0/6 (0.00%) |
1/7 (14.29%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
2/7 (28.57%) |
0/18 (0.00%) |
Dry eye |
0/6 (0.00%) |
0/7 (0.00%) |
2/6 (33.33%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/7 (0.00%) |
0/18 (0.00%) |
Extraocular muscle paresis |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/7 (14.29%) |
0/18 (0.00%) |
Eye disorders: eye lids twitching |
0/6 (0.00%) |
1/7 (14.29%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/7 (14.29%) |
0/18 (0.00%) |
Watering eyes |
0/6 (0.00%) |
2/7 (28.57%) |
1/6 (16.67%) |
1/6 (16.67%) |
1/6 (16.67%) |
2/7 (28.57%) |
0/18 (0.00%) |
Gastrointestinal disorders |
|
|
|
|
|
|
|
Abdominal pain |
1/6 (16.67%) |
0/7 (0.00%) |
0/6 (0.00%) |
2/6 (33.33%) |
0/6 (0.00%) |
1/7 (14.29%) |
0/18 (0.00%) |
Anal mucositis |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
1/7 (14.29%) |
0/18 (0.00%) |
Ascites |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/18 (0.00%) |
Constipation |
2/6 (33.33%) |
5/7 (71.43%) |
4/6 (66.67%) |
3/6 (50.00%) |
4/6 (66.67%) |
3/7 (42.86%) |
0/18 (0.00%) |
Diarrhea |
1/6 (16.67%) |
4/7 (57.14%) |
1/6 (16.67%) |
3/6 (50.00%) |
1/6 (16.67%) |
3/7 (42.86%) |
0/18 (0.00%) |
Dry mouth |
1/6 (16.67%) |
1/7 (14.29%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/7 (14.29%) |
0/18 (0.00%) |
Dyspepsia |
0/6 (0.00%) |
0/7 (0.00%) |
1/6 (16.67%) |
2/6 (33.33%) |
1/6 (16.67%) |
1/7 (14.29%) |
0/18 (0.00%) |
Dysphagia |
0/6 (0.00%) |
0/7 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/18 (0.00%) |
Esophagitis |
0/6 (0.00%) |
0/7 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/18 (0.00%) |
Gastrointestinal disorders: inflamed gums |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
1/7 (14.29%) |
0/18 (0.00%) |
Hemorrhoids |
2/6 (33.33%) |
0/7 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
1/6 (16.67%) |
2/7 (28.57%) |
0/18 (0.00%) |
Mucositis oral |
2/6 (33.33%) |
3/7 (42.86%) |
2/6 (33.33%) |
3/6 (50.00%) |
1/6 (16.67%) |
3/7 (42.86%) |
0/18 (0.00%) |
Nausea |
2/6 (33.33%) |
2/7 (28.57%) |
4/6 (66.67%) |
2/6 (33.33%) |
2/6 (33.33%) |
3/7 (42.86%) |
0/18 (0.00%) |
Rectal hemorrhage |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/7 (0.00%) |
0/18 (0.00%) |
Rectal pain |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/7 (0.00%) |
0/18 (0.00%) |
Vomiting |
3/6 (50.00%) |
1/7 (14.29%) |
3/6 (50.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/7 (0.00%) |
0/18 (0.00%) |
General disorders |
|
|
|
|
|
|
|
Edema face |
0/6 (0.00%) |
1/7 (14.29%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/18 (0.00%) |
Edema limbs |
2/6 (33.33%) |
3/7 (42.86%) |
1/6 (16.67%) |
1/6 (16.67%) |
1/6 (16.67%) |
1/7 (14.29%) |
0/18 (0.00%) |
Edema trunk |
2/6 (33.33%) |
0/7 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/18 (0.00%) |
Fatigue |
2/6 (33.33%) |
5/7 (71.43%) |
5/6 (83.33%) |
6/6 (100.00%) |
5/6 (83.33%) |
6/7 (85.71%) |
0/18 (0.00%) |
Fever |
1/6 (16.67%) |
1/7 (14.29%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/18 (0.00%) |
General disorders and administration site conditions: cold intolerance |
1/6 (16.67%) |
2/7 (28.57%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
1/7 (14.29%) |
0/18 (0.00%) |
Non-cardiac chest pain |
0/6 (0.00%) |
1/7 (14.29%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/7 (14.29%) |
0/18 (0.00%) |
Pain |
1/6 (16.67%) |
1/7 (14.29%) |
1/6 (16.67%) |
2/6 (33.33%) |
1/6 (16.67%) |
1/7 (14.29%) |
0/18 (0.00%) |
Immune system disorders |
|
|
|
|
|
|
|
Allergic reaction |
0/6 (0.00%) |
2/7 (28.57%) |
1/6 (16.67%) |
1/6 (16.67%) |
0/6 (0.00%) |
2/7 (28.57%) |
0/18 (0.00%) |
Infections and infestations |
|
|
|
|
|
|
|
Infections and infestations: UTI |
2/6 (33.33%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/7 (14.29%) |
0/18 (0.00%) |
Lymph gland infection |
0/6 (0.00%) |
0/7 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/18 (0.00%) |
Urinary tract infection |
0/6 (0.00%) |
1/7 (14.29%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/18 (0.00%) |
Vaginal infection |
0/6 (0.00%) |
1/7 (14.29%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/18 (0.00%) |
Injury, poisoning and procedural complications |
|
|
|
|
|
|
|
Bruising |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/18 (0.00%) |
Investigations |
|
|
|
|
|
|
|
Alanine aminotransferase increased |
0/6 (0.00%) |
1/7 (14.29%) |
1/6 (16.67%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/18 (0.00%) |
Alkaline phosphatase increased |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/18 (0.00%) |
Aspartate aminotransferase increased |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/18 (0.00%) |
Neutrophil count decreased |
1/6 (16.67%) |
0/7 (0.00%) |
3/6 (50.00%) |
1/6 (16.67%) |
2/6 (33.33%) |
1/7 (14.29%) |
0/18 (0.00%) |
Platelet count decreased |
1/6 (16.67%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/18 (0.00%) |
Weight gain |
0/6 (0.00%) |
1/7 (14.29%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/18 (0.00%) |
Weight loss |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/7 (0.00%) |
0/18 (0.00%) |
White blood cell decreased |
2/6 (33.33%) |
0/7 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
2/6 (33.33%) |
2/7 (28.57%) |
0/18 (0.00%) |
Metabolism and nutrition disorders |
|
|
|
|
|
|
|
Acidosis |
1/6 (16.67%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/18 (0.00%) |
Anorexia |
0/6 (0.00%) |
2/7 (28.57%) |
1/6 (16.67%) |
5/6 (83.33%) |
1/6 (16.67%) |
5/7 (71.43%) |
0/18 (0.00%) |
Hyperglycemia |
2/6 (33.33%) |
2/7 (28.57%) |
0/6 (0.00%) |
2/6 (33.33%) |
0/6 (0.00%) |
4/7 (57.14%) |
0/18 (0.00%) |
Hyperkalemia |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
1/7 (14.29%) |
0/18 (0.00%) |
Hypernatremia |
1/6 (16.67%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/18 (0.00%) |
Hypocalcemia |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/7 (14.29%) |
0/18 (0.00%) |
Hypokalemia |
1/6 (16.67%) |
0/7 (0.00%) |
2/6 (33.33%) |
1/6 (16.67%) |
1/6 (16.67%) |
1/7 (14.29%) |
0/18 (0.00%) |
Hyponatremia |
1/6 (16.67%) |
1/7 (14.29%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/7 (14.29%) |
0/18 (0.00%) |
Musculoskeletal and connective tissue disorders |
|
|
|
|
|
|
|
Arthralgia |
2/6 (33.33%) |
2/7 (28.57%) |
3/6 (50.00%) |
2/6 (33.33%) |
0/6 (0.00%) |
5/7 (71.43%) |
0/18 (0.00%) |
Arthritis |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/18 (0.00%) |
Back pain |
4/6 (66.67%) |
1/7 (14.29%) |
0/6 (0.00%) |
1/6 (16.67%) |
1/6 (16.67%) |
2/7 (28.57%) |
0/18 (0.00%) |
Bone pain |
0/6 (0.00%) |
1/7 (14.29%) |
1/6 (16.67%) |
1/6 (16.67%) |
1/6 (16.67%) |
1/7 (14.29%) |
0/18 (0.00%) |
Chest wall pain |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/18 (0.00%) |
Generalized muscle weakness |
0/6 (0.00%) |
0/7 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/18 (0.00%) |
Musculoskeletal and connective tissue disorder : muscle tightness |
0/6 (0.00%) |
1/7 (14.29%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/18 (0.00%) |
Myalgia |
1/6 (16.67%) |
2/7 (28.57%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/7 (14.29%) |
0/18 (0.00%) |
Neck pain |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
2/7 (28.57%) |
0/18 (0.00%) |
Pain in extremity |
2/6 (33.33%) |
2/7 (28.57%) |
1/6 (16.67%) |
1/6 (16.67%) |
1/6 (16.67%) |
2/7 (28.57%) |
0/18 (0.00%) |
Nervous system disorders |
|
|
|
|
|
|
|
Ataxia |
0/6 (0.00%) |
0/7 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/18 (0.00%) |
Dizziness |
0/6 (0.00%) |
2/7 (28.57%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
2/7 (28.57%) |
0/18 (0.00%) |
Dysgeusia |
3/6 (50.00%) |
3/7 (42.86%) |
2/6 (33.33%) |
3/6 (50.00%) |
0/6 (0.00%) |
4/7 (57.14%) |
0/18 (0.00%) |
Headache |
5/6 (83.33%) |
4/7 (57.14%) |
5/6 (83.33%) |
5/6 (83.33%) |
4/6 (66.67%) |
3/7 (42.86%) |
0/18 (0.00%) |
Memory impairment |
1/6 (16.67%) |
1/7 (14.29%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/18 (0.00%) |
Peripheral sensory neuropathy |
3/6 (50.00%) |
3/7 (42.86%) |
2/6 (33.33%) |
1/6 (16.67%) |
2/6 (33.33%) |
4/7 (57.14%) |
0/18 (0.00%) |
Sinus pain |
0/6 (0.00%) |
0/7 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/18 (0.00%) |
Syncope |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/7 (14.29%) |
0/18 (0.00%) |
Psychiatric disorders |
|
|
|
|
|
|
|
Agitation |
1/6 (16.67%) |
0/7 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/7 (14.29%) |
0/18 (0.00%) |
Anxiety |
0/6 (0.00%) |
1/7 (14.29%) |
0/6 (0.00%) |
0/6 (0.00%) |
3/6 (50.00%) |
1/7 (14.29%) |
0/18 (0.00%) |
Depression |
1/6 (16.67%) |
4/7 (57.14%) |
0/6 (0.00%) |
2/6 (33.33%) |
0/6 (0.00%) |
1/7 (14.29%) |
0/18 (0.00%) |
Insomnia |
3/6 (50.00%) |
4/7 (57.14%) |
3/6 (50.00%) |
4/6 (66.67%) |
2/6 (33.33%) |
4/7 (57.14%) |
0/18 (0.00%) |
Renal and urinary disorders |
|
|
|
|
|
|
|
Cystitis noninfective |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/18 (0.00%) |
Urinary frequency |
1/6 (16.67%) |
0/7 (0.00%) |
2/6 (33.33%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/18 (0.00%) |
Urinary tract pain |
1/6 (16.67%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/7 (0.00%) |
0/18 (0.00%) |
Reproductive system and breast disorders |
|
|
|
|
|
|
|
Breast pain |
2/6 (33.33%) |
3/7 (42.86%) |
1/6 (16.67%) |
3/6 (50.00%) |
3/6 (50.00%) |
0/7 (0.00%) |
1/18 (5.56%) |
Uterine pain |
0/6 (0.00%) |
1/7 (14.29%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/18 (0.00%) |
Vaginal discharge |
0/6 (0.00%) |
1/7 (14.29%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/18 (0.00%) |
Vaginal dryness |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
1/7 (14.29%) |
0/18 (0.00%) |
Vaginal pain |
0/6 (0.00%) |
1/7 (14.29%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/18 (0.00%) |
Respiratory, thoracic and mediastinal disorders |
|
|
|
|
|
|
|
Allergic rhinitis |
3/6 (50.00%) |
2/7 (28.57%) |
6/6 (100.00%) |
3/6 (50.00%) |
3/6 (50.00%) |
3/7 (42.86%) |
0/18 (0.00%) |
Bronchospasm |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/7 (14.29%) |
0/18 (0.00%) |
Cough |
3/6 (50.00%) |
0/7 (0.00%) |
2/6 (33.33%) |
2/6 (33.33%) |
1/6 (16.67%) |
1/7 (14.29%) |
0/18 (0.00%) |
Dyspnea |
1/6 (16.67%) |
1/7 (14.29%) |
3/6 (50.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
1/7 (14.29%) |
0/18 (0.00%) |
Laryngeal mucositis |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
1/7 (14.29%) |
0/18 (0.00%) |
Pharyngolaryngeal pain |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
2/7 (28.57%) |
0/18 (0.00%) |
Respiratory, thoracic and mediastinal disorders: dyspnea on exertion |
0/6 (0.00%) |
1/7 (14.29%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/7 (14.29%) |
0/18 (0.00%) |
Sinus disorder |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
1/6 (16.67%) |
0/7 (0.00%) |
0/18 (0.00%) |
Voice alteration |
0/6 (0.00%) |
1/7 (14.29%) |
2/6 (33.33%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/18 (0.00%) |
Skin and subcutaneous tissue disorders |
|
|
|
|
|
|
|
Alopecia |
5/6 (83.33%) |
5/7 (71.43%) |
2/6 (33.33%) |
2/6 (33.33%) |
5/6 (83.33%) |
2/7 (28.57%) |
0/18 (0.00%) |
Dry skin |
0/6 (0.00%) |
1/7 (14.29%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
1/7 (14.29%) |
0/18 (0.00%) |
Hyperhidrosis |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
1/6 (16.67%) |
0/7 (0.00%) |
0/18 (0.00%) |
Nail loss |
1/6 (16.67%) |
0/7 (0.00%) |
2/6 (33.33%) |
0/6 (0.00%) |
1/6 (16.67%) |
3/7 (42.86%) |
0/18 (0.00%) |
Palmar-plantar erythrodysesthesia syndrome |
0/6 (0.00%) |
1/7 (14.29%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/18 (0.00%) |
Pruritus |
3/6 (50.00%) |
1/7 (14.29%) |
1/6 (16.67%) |
1/6 (16.67%) |
0/6 (0.00%) |
1/7 (14.29%) |
0/18 (0.00%) |
Purpura |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/18 (0.00%) |
Rash acneiform |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/7 (14.29%) |
0/18 (0.00%) |
Rash maculo-papular |
0/6 (0.00%) |
1/7 (14.29%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/18 (0.00%) |
Skin and subcutaneous tissue disorders: nose sores |
0/6 (0.00%) |
0/7 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/18 (0.00%) |
Skin ulceration |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/7 (14.29%) |
0/18 (0.00%) |
Vascular disorders |
|
|
|
|
|
|
|
Flushing |
0/6 (0.00%) |
1/7 (14.29%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/7 (14.29%) |
0/18 (0.00%) |
Hematoma |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/7 (14.29%) |
0/18 (0.00%) |
Hot flashes |
2/6 (33.33%) |
3/7 (42.86%) |
3/6 (50.00%) |
1/6 (16.67%) |
2/6 (33.33%) |
3/7 (42.86%) |
0/18 (0.00%) |
Hypertension |
1/6 (16.67%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
1/7 (14.29%) |
0/18 (0.00%) |
Vascular disorders: easy bruising |
0/6 (0.00%) |
0/7 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/18 (0.00%) |
Vascular disorders: epitaxsis |
0/6 (0.00%) |
1/7 (14.29%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/18 (0.00%) |
Indicates events were collected by systematic assessment
Term from vocabulary, CTCAE (4.0)
|