Trial Outcomes & Findings for Combination Chemotherapy With or Without Trastuzumab Followed By an Autologous Stem Cell Transplant and Radiation Therapy in Treating Patients With Stage III or Stage IV Breast Cancer (NCT NCT00182793)
NCT ID: NCT00182793
Last Updated: 2017-02-23
Results Overview
Estimated using the product-limit method of Kaplan and Meier. Relapse defined as appearance of any new lesions during or after protocol treatment. Whenever possible, relapses should be documented histologically.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
32 participants
Primary outcome timeframe
From time of initial PBPC rescue until death or disease recurrence (disease progression for patients with stage IV disease), whichever came first, up to 5 years post treatment
Results posted on
2017-02-23
Participant Flow
Participant milestones
| Measure |
All Patients
Patients undergo stem cell collection. Patients receive high-dose melphalan IV with or without trastuzumab (Herceptin®), one day later, patients undergo autologous peripheral blood stem cell (PBSC) transplantation, no more than 7 weeks later, patients proceed to course 2; OR Patients receive high-dose carboplatin, thiotepa, and cyclophosphamide IV continuously over 4 days followed by autologous PBSC transplantation. After recover from high-dose chemotherapy and autologous PBSC transplantation, patients with stage IIIB or IIIC disease undergo radiotherapy to the chest wall and lymph nodes. Patients with stage IV disease undergo radiotherapy using helical tomotherapy or standard radiotherapy to oligometastatic sites.
|
|---|---|
|
Overall Study
STARTED
|
32
|
|
Overall Study
COMPLETED
|
32
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Combination Chemotherapy With or Without Trastuzumab Followed By an Autologous Stem Cell Transplant and Radiation Therapy in Treating Patients With Stage III or Stage IV Breast Cancer
Baseline characteristics by cohort
| Measure |
All Patients
n=32 Participants
Patients undergo stem cell collection. Patients receive high-dose melphalan IV with or without trastuzumab (Herceptin®), one day later, patients undergo autologous peripheral blood stem cell (PBSC) transplantation, no more than 7 weeks later, patients proceed to course 2; OR Patients receive high-dose carboplatin, thiotepa, and cyclophosphamide IV continuously over 4 days followed by autologous PBSC transplantation. After recover from high-dose chemotherapy and autologous PBSC transplantation, patients with stage IIIB or IIIC disease undergo radiotherapy to the chest wall and lymph nodes. Patients with stage IV disease undergo radiotherapy using helical tomotherapy or standard radiotherapy to oligometastatic sites.
|
|---|---|
|
Age, Continuous
|
47 years
n=39 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: From time of initial PBPC rescue until death or disease recurrence (disease progression for patients with stage IV disease), whichever came first, up to 5 years post treatmentPopulation: Patients from this study were combined with patients from a follow-up study in which 27 patients from this study met the eligibility requirements for meta-analysis.
Estimated using the product-limit method of Kaplan and Meier. Relapse defined as appearance of any new lesions during or after protocol treatment. Whenever possible, relapses should be documented histologically.
Outcome measures
| Measure |
All Patients
n=27 Participants
Patients undergo stem cell collection. Patients receive high-dose melphalan IV with or without trastuzumab (Herceptin®), one day later, patients undergo autologous peripheral blood stem cell (PBSC) transplantation, no more than 7 weeks later, patients proceed to course 2; OR Patients receive high-dose carboplatin, thiotepa, and cyclophosphamide IV continuously over 4 days followed by autologous PBSC transplantation. After recover from high-dose chemotherapy and autologous PBSC transplantation, patients with stage IIIB or IIIC disease undergo radiotherapy to the chest wall and lymph nodes. Patients with stage IV disease undergo radiotherapy using helical tomotherapy or standard radiotherapy to oligometastatic sites.
|
|---|---|
|
5-Year Relapse-free Survival Rate
|
53 percentage of participants
Interval 23.0 to 77.0
|
PRIMARY outcome
Timeframe: From time of initial PBPC rescue until the date of death from any cause, assessed up to 5 years post treatment.Population: Patients from this study were combined with patients from a follow-up study in which 27 patients from this study met the eligibility requirements for meta-analysis.
Estimated using the product-limit method of Kaplan and Meier. Patients who were still alive were censored at the date of last follow-up
Outcome measures
| Measure |
All Patients
n=27 Participants
Patients undergo stem cell collection. Patients receive high-dose melphalan IV with or without trastuzumab (Herceptin®), one day later, patients undergo autologous peripheral blood stem cell (PBSC) transplantation, no more than 7 weeks later, patients proceed to course 2; OR Patients receive high-dose carboplatin, thiotepa, and cyclophosphamide IV continuously over 4 days followed by autologous PBSC transplantation. After recover from high-dose chemotherapy and autologous PBSC transplantation, patients with stage IIIB or IIIC disease undergo radiotherapy to the chest wall and lymph nodes. Patients with stage IV disease undergo radiotherapy using helical tomotherapy or standard radiotherapy to oligometastatic sites.
|
|---|---|
|
5-Year Overall Survival Rate
|
75 percentage of participants
Interval 41.0 to 92.0
|
Adverse Events
All Patients
Serious events: 24 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
All Patients
n=32 participants at risk
Patients undergo stem cell collection. Patients receive high-dose melphalan IV with or without trastuzumab (Herceptin®), one day later, patients undergo autologous peripheral blood stem cell (PBSC) transplantation, no more than 7 weeks later, patients proceed to course 2; OR Patients receive high-dose carboplatin, thiotepa, and cyclophosphamide IV continuously over 4 days followed by autologous PBSC transplantation. After recover from high-dose chemotherapy and autologous PBSC transplantation, patients with stage IIIB or IIIC disease undergo radiotherapy to the chest wall and lymph nodes. Patients with stage IV disease undergo radiotherapy using helical tomotherapy or standard radiotherapy to oligometastatic sites.
|
|---|---|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
3.1%
1/32 • Number of events 1 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.1%
1/32 • Number of events 1 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Endocrine disorders
Adrenal insufficiency
|
3.1%
1/32 • Number of events 1 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Endocrine disorders
Endocrine disorder
|
3.1%
1/32 • Number of events 1 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Chills
|
3.1%
1/32 • Number of events 1 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Fatigue
|
3.1%
1/32 • Number of events 1 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Fever
|
3.1%
1/32 • Number of events 1 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Multi-organ failure
|
3.1%
1/32 • Number of events 2 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Hepatobiliary disorders
Hepatic failure
|
3.1%
1/32 • Number of events 1 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Infection
|
3.1%
1/32 • Number of events 1 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Sepsis
|
3.1%
1/32 • Number of events 1 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Injury, poisoning and procedural complications
Prolonged intubation after pulmonary resection (>24 hrs after surgery)
|
3.1%
1/32 • Number of events 1 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Alanine aminotransferase increased
|
3.1%
1/32 • Number of events 1 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
3.1%
1/32 • Number of events 1 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Bilirubin increased
|
3.1%
1/32 • Number of events 1 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Creatinine increased
|
3.1%
1/32 • Number of events 1 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Acidosis
|
3.1%
1/32 • Number of events 1 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum glucose decreased
|
3.1%
1/32 • Number of events 1 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
3.1%
1/32 • Number of events 1 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
3.1%
1/32 • Number of events 1 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Renal failure
|
3.1%
1/32 • Number of events 1 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
3.1%
1/32 • Number of events 1 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.1%
1/32 • Number of events 1 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Hypotension
|
3.1%
1/32 • Number of events 1 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
Other adverse events
| Measure |
All Patients
n=32 participants at risk
Patients undergo stem cell collection. Patients receive high-dose melphalan IV with or without trastuzumab (Herceptin®), one day later, patients undergo autologous peripheral blood stem cell (PBSC) transplantation, no more than 7 weeks later, patients proceed to course 2; OR Patients receive high-dose carboplatin, thiotepa, and cyclophosphamide IV continuously over 4 days followed by autologous PBSC transplantation. After recover from high-dose chemotherapy and autologous PBSC transplantation, patients with stage IIIB or IIIC disease undergo radiotherapy to the chest wall and lymph nodes. Patients with stage IV disease undergo radiotherapy using helical tomotherapy or standard radiotherapy to oligometastatic sites.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
40.6%
13/32 • Number of events 15 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
93.8%
30/32 • Number of events 53 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Blood and lymphatic system disorders
Lymphatic disorder
|
3.1%
1/32 • Number of events 1 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Arrhythmia
|
3.1%
1/32 • Number of events 1 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Cardiac disorder
|
3.1%
1/32 • Number of events 1 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Left ventricular failure
|
3.1%
1/32 • Number of events 1 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Palpitations
|
3.1%
1/32 • Number of events 1 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Premature ventricular contractions
|
6.2%
2/32 • Number of events 2 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Sinus tachycardia
|
75.0%
24/32 • Number of events 36 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Supraventricular tachycardia
|
6.2%
2/32 • Number of events 2 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Ventricular tachycardia
|
3.1%
1/32 • Number of events 1 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Ear and labyrinth disorders
External ear pain
|
3.1%
1/32 • Number of events 1 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Endocrine disorders
Endocrine disorder
|
3.1%
1/32 • Number of events 1 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Eye disorders
Dry eye syndrome
|
6.2%
2/32 • Number of events 2 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Eye disorders
Vision blurred
|
12.5%
4/32 • Number of events 4 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
15.6%
5/32 • Number of events 5 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
53.1%
17/32 • Number of events 22 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Anal pain
|
3.1%
1/32 • Number of events 1 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Colitis
|
3.1%
1/32 • Number of events 1 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
8/32 • Number of events 11 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
81.2%
26/32 • Number of events 40 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
15.6%
5/32 • Number of events 5 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
34.4%
11/32 • Number of events 14 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
18.8%
6/32 • Number of events 7 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
50.0%
16/32 • Number of events 21 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Enteritis
|
6.2%
2/32 • Number of events 2 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Flatulence
|
12.5%
4/32 • Number of events 4 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Gastritis
|
15.6%
5/32 • Number of events 6 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
28.1%
9/32 • Number of events 13 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Gingival pain
|
6.2%
2/32 • Number of events 2 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Hemorrhoids
|
18.8%
6/32 • Number of events 6 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Intra-abdominal hemorrhage
|
3.1%
1/32 • Number of events 1 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
3.1%
1/32 • Number of events 1 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Mucositis oral
|
21.9%
7/32 • Number of events 8 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Nausea
|
84.4%
27/32 • Number of events 47 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Oral hemorrhage
|
3.1%
1/32 • Number of events 1 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Oral pain
|
31.2%
10/32 • Number of events 11 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Proctitis
|
3.1%
1/32 • Number of events 1 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
6.2%
2/32 • Number of events 2 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Rectal mucositis
|
3.1%
1/32 • Number of events 1 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Rectal pain
|
3.1%
1/32 • Number of events 1 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
3.1%
1/32 • Number of events 1 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Vomiting
|
68.8%
22/32 • Number of events 32 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Chest pain
|
9.4%
3/32 • Number of events 3 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Chills
|
50.0%
16/32 • Number of events 23 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Edema limbs
|
50.0%
16/32 • Number of events 25 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Fatigue
|
81.2%
26/32 • Number of events 43 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Fever
|
53.1%
17/32 • Number of events 21 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
General symptom
|
3.1%
1/32 • Number of events 1 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Injection site reaction
|
43.8%
14/32 • Number of events 16 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Irritability
|
3.1%
1/32 • Number of events 1 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Localized edema
|
9.4%
3/32 • Number of events 4 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Pain
|
37.5%
12/32 • Number of events 15 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Catheter related infection
|
3.1%
1/32 • Number of events 1 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Colitis, infectious (e.g., Clostridium difficile)
|
3.1%
1/32 • Number of events 1 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Gingival infection
|
3.1%
1/32 • Number of events 1 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Opportunistic infection
|
3.1%
1/32 • Number of events 1 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Sepsis
|
21.9%
7/32 • Number of events 8 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Sinusitis
|
9.4%
3/32 • Number of events 3 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Skin infection
|
9.4%
3/32 • Number of events 3 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Upper aerodigestive tract infection
|
6.2%
2/32 • Number of events 2 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Upper respiratory infection
|
3.1%
1/32 • Number of events 1 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Urinary tract infection
|
6.2%
2/32 • Number of events 2 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Injury, poisoning and procedural complications
Intraoperative gastrointestinal injury - Teeth
|
3.1%
1/32 • Number of events 1 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
31.2%
10/32 • Number of events 12 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Alanine aminotransferase increased
|
65.6%
21/32 • Number of events 33 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Alkaline phosphatase increased
|
31.2%
10/32 • Number of events 12 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
71.9%
23/32 • Number of events 32 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Coagulopathy
|
50.0%
16/32 • Number of events 24 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Hypercholesterolemia
|
6.2%
2/32 • Number of events 2 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
INR increased
|
9.4%
3/32 • Number of events 3 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Leukocyte count decreased
|
68.8%
22/32 • Number of events 40 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Leukopenia
|
15.6%
5/32 • Number of events 10 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Lymphocyte count decreased
|
15.6%
5/32 • Number of events 10 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Lymphopenia
|
15.6%
5/32 • Number of events 9 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Neutrophil count decreased
|
81.2%
26/32 • Number of events 48 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Platelet count decreased
|
87.5%
28/32 • Number of events 50 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Serum cholesterol increased
|
21.9%
7/32 • Number of events 9 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Weight gain
|
15.6%
5/32 • Number of events 5 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Weight loss
|
9.4%
3/32 • Number of events 3 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
71.9%
23/32 • Number of events 36 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Blood bicarbonate decreased
|
37.5%
12/32 • Number of events 16 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
71.9%
23/32 • Number of events 37 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Blood uric acid increased
|
3.1%
1/32 • Number of events 1 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
21.9%
7/32 • Number of events 7 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
3.1%
1/32 • Number of events 1 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
15.6%
5/32 • Number of events 6 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
3.1%
1/32 • Number of events 1 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
15.6%
5/32 • Number of events 9 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
12.5%
4/32 • Number of events 6 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
3.1%
1/32 • Number of events 1 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
15.6%
5/32 • Number of events 8 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
15.6%
5/32 • Number of events 7 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
12.5%
4/32 • Number of events 4 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
15.6%
5/32 • Number of events 9 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
68.8%
22/32 • Number of events 38 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
43.8%
14/32 • Number of events 22 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum calcium increased
|
3.1%
1/32 • Number of events 1 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum glucose decreased
|
6.2%
2/32 • Number of events 2 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum magnesium decreased
|
50.0%
16/32 • Number of events 22 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum magnesium increased
|
6.2%
2/32 • Number of events 2 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
53.1%
17/32 • Number of events 20 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
53.1%
17/32 • Number of events 23 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
59.4%
19/32 • Number of events 21 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum triglycerides increased
|
15.6%
5/32 • Number of events 6 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
18.8%
6/32 • Number of events 6 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
31.2%
10/32 • Number of events 11 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
6.2%
2/32 • Number of events 3 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
9.4%
3/32 • Number of events 4 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
3.1%
1/32 • Number of events 1 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
3.1%
1/32 • Number of events 1 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
18.8%
6/32 • Number of events 7 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
9.4%
3/32 • Number of events 4 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.1%
1/32 • Number of events 1 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Depressed level of consciousness
|
6.2%
2/32 • Number of events 2 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Dizziness
|
31.2%
10/32 • Number of events 11 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Headache
|
62.5%
20/32 • Number of events 33 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Neurological disorder NOS
|
9.4%
3/32 • Number of events 3 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
3.1%
1/32 • Number of events 2 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
28.1%
9/32 • Number of events 12 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Sinus pain
|
9.4%
3/32 • Number of events 3 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Taste alteration
|
25.0%
8/32 • Number of events 10 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Tremor
|
3.1%
1/32 • Number of events 1 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Agitation
|
3.1%
1/32 • Number of events 1 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Anxiety
|
40.6%
13/32 • Number of events 17 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Confusion
|
6.2%
2/32 • Number of events 2 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Depression
|
21.9%
7/32 • Number of events 8 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Insomnia
|
37.5%
12/32 • Number of events 13 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Personality change
|
3.1%
1/32 • Number of events 2 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Psychosis
|
6.2%
2/32 • Number of events 2 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Cystitis
|
3.1%
1/32 • Number of events 1 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Hemorrhage urinary tract
|
15.6%
5/32 • Number of events 6 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Renal failure
|
3.1%
1/32 • Number of events 1 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Urogenital disorder
|
9.4%
3/32 • Number of events 6 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Reproductive system and breast disorders
Irregular menstruation
|
3.1%
1/32 • Number of events 1 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Reproductive system and breast disorders
Pelvic pain
|
3.1%
1/32 • Number of events 1 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Reproductive system and breast disorders
Vaginal dryness
|
3.1%
1/32 • Number of events 1 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
3.1%
1/32 • Number of events 1 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Reproductive system and breast disorders
Vaginal pain
|
3.1%
1/32 • Number of events 1 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
12.5%
4/32 • Number of events 6 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
9.4%
3/32 • Number of events 3 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
46.9%
15/32 • Number of events 18 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
18.8%
6/32 • Number of events 8 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage nasal
|
25.0%
8/32 • Number of events 8 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccough
|
9.4%
3/32 • Number of events 3 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
40.6%
13/32 • Number of events 15 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.1%
1/32 • Number of events 1 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.1%
1/32 • Number of events 1 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
18.8%
6/32 • Number of events 8 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
3.1%
1/32 • Number of events 1 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
43.8%
14/32 • Number of events 16 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
6.2%
2/32 • Number of events 2 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.1%
1/32 • Number of events 1 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Hand-and-foot syndrome
|
3.1%
1/32 • Number of events 1 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
9.4%
3/32 • Number of events 3 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
6.2%
2/32 • Number of events 2 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.5%
4/32 • Number of events 4 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
3.1%
1/32 • Number of events 1 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
31.2%
10/32 • Number of events 11 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
12.5%
4/32 • Number of events 7 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
6.2%
2/32 • Number of events 2 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
3.1%
1/32 • Number of events 1 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Sweating
|
6.2%
2/32 • Number of events 2 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Telangiectasia
|
3.1%
1/32 • Number of events 1 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
6.2%
2/32 • Number of events 2 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Flushing
|
18.8%
6/32 • Number of events 9 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Hemorrhage
|
6.2%
2/32 • Number of events 3 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Hot flashes
|
21.9%
7/32 • Number of events 10 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Hypertension
|
15.6%
5/32 • Number of events 5 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Hypotension
|
65.6%
21/32 • Number of events 35 • Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place