Trial Outcomes & Findings for Combination Chemotherapy in Treating Patients With High-Risk Breast Cancer (NCT NCT00004092)
NCT ID: NCT00004092
Last Updated: 2015-08-04
Results Overview
RFS events included death or disease recurrence. Patients who did not experience disease recurrence or death were censored at the date of last follow-up. Survival rates were estimates using the Kaplan-Meier method.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
72 participants
Primary outcome timeframe
Five years
Results posted on
2015-08-04
Participant Flow
Participant milestones
| Measure |
Arm I (ACT)
Patients receive 41.25 mg/m2 of doxorubicin IV over 24 hours on days -9 to -6, 100 mg/kg of cyclophosphamide IV over 2 hours on day -5, and 725 mg/m2 of paclitaxel IV over 24 hours on day -4. PBSC are reinfused on days -2 and 0. G-CSF at 5 ug/kg IV is administered beginning on day 0 and continuing until blood counts recover.
filgrastim: Given IV or subcutaneously
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV
peripheral blood stem cell transplantation: Patients receive autologous peripheral blood stem cells
|
Arm II (STAMP V)
Patients receive cyclophosphamide 1.5 g/m2/day IV, carboplatin 200 mg/m2/day IV, and thiotepa 125 mg/m2/day IV over 24 hours on days -7 to -4. PBSC are reinfused on day -2 and 0 and G-CSF at 5ug/kg IV is administered as in arm I.
filgrastim: Given IV or subcutaneously
carboplatin: Given IV
cyclophosphamide: Given IV
thiotepa: Given IV
peripheral blood stem cell transplantation: Patients receive autologous peripheral blood stem cells
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
51
|
|
Overall Study
COMPLETED
|
21
|
51
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Combination Chemotherapy in Treating Patients With High-Risk Breast Cancer
Baseline characteristics by cohort
| Measure |
Arm I (ACT)
n=21 Participants
Patients receive 41.25 mg/m2 of doxorubicin IV over 24 hours on days -9 to -6, 100 mg/kg of cyclophosphamide IV over 2 hours on day -5, and 725 mg/m2 of paclitaxel IV over 24 hours on day -4. PBSC are reinfused on days -2 and 0. G-CSF at 5 ug/kg IV is administered beginning on day 0 and continuing until blood counts recover.
filgrastim: Given IV or subcutaneously
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV
peripheral blood stem cell transplantation: Patients receive autologous peripheral blood stem cells
|
Arm II (STAMP V)
n=51 Participants
Patients receive cyclophosphamide 1.5 g/m2/day IV, carboplatin 200 mg/m2/day IV, and thiotepa 125 mg/m2/day IV over 24 hours on days -7 to -4. PBSC are reinfused on day -2 and 0 and G-CSF at 5ug/kg IV is administered as in arm I.
filgrastim: Given IV or subcutaneously
carboplatin: Given IV
cyclophosphamide: Given IV
thiotepa: Given IV
peripheral blood stem cell transplantation: Patients receive autologous peripheral blood stem cells
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42 years
n=99 Participants
|
51 years
n=107 Participants
|
50 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=99 Participants
|
51 Participants
n=107 Participants
|
72 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=99 Participants
|
51 participants
n=107 Participants
|
72 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Five yearsRFS events included death or disease recurrence. Patients who did not experience disease recurrence or death were censored at the date of last follow-up. Survival rates were estimates using the Kaplan-Meier method.
Outcome measures
| Measure |
Arm I (ACT)
n=21 Participants
Patients receive 41.25 mg/m2 of doxorubicin IV over 24 hours on days -9 to -6, 100 mg/kg of cyclophosphamide IV over 2 hours on day -5, and 725 mg/m2 of paclitaxel IV over 24 hours on day -4. PBSC are reinfused on days -2 and 0. G-CSF at 5 ug/kg IV is administered beginning on day 0 and continuing until blood counts recover.
filgrastim: Given IV or subcutaneously
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV
peripheral blood stem cell transplantation: Patients receive autologous peripheral blood stem cells
|
Arm II (STAMP V)
n=51 Participants
Patients receive cyclophosphamide 1.5 g/m2/day IV, carboplatin 200 mg/m2/day IV, and thiotepa 125 mg/m2/day IV over 24 hours on days -7 to -4. PBSC are reinfused on day -2 and 0 and G-CSF at 5ug/kg IV is administered as in arm I.
filgrastim: Given IV or subcutaneously
carboplatin: Given IV
cyclophosphamide: Given IV
thiotepa: Given IV
peripheral blood stem cell transplantation: Patients receive autologous peripheral blood stem cells
|
|---|---|---|
|
Five-Year Relapse-free Survival
|
47 percentage of participants
Interval 24.0 to 67.0
|
55 percentage of participants
Interval 41.0 to 68.0
|
SECONDARY outcome
Timeframe: Five YearsPatients who were still alive were censored at the date of last follow-up. Survival rates were estimates using the Kaplan-Meier method.
Outcome measures
| Measure |
Arm I (ACT)
n=21 Participants
Patients receive 41.25 mg/m2 of doxorubicin IV over 24 hours on days -9 to -6, 100 mg/kg of cyclophosphamide IV over 2 hours on day -5, and 725 mg/m2 of paclitaxel IV over 24 hours on day -4. PBSC are reinfused on days -2 and 0. G-CSF at 5 ug/kg IV is administered beginning on day 0 and continuing until blood counts recover.
filgrastim: Given IV or subcutaneously
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV
peripheral blood stem cell transplantation: Patients receive autologous peripheral blood stem cells
|
Arm II (STAMP V)
n=51 Participants
Patients receive cyclophosphamide 1.5 g/m2/day IV, carboplatin 200 mg/m2/day IV, and thiotepa 125 mg/m2/day IV over 24 hours on days -7 to -4. PBSC are reinfused on day -2 and 0 and G-CSF at 5ug/kg IV is administered as in arm I.
filgrastim: Given IV or subcutaneously
carboplatin: Given IV
cyclophosphamide: Given IV
thiotepa: Given IV
peripheral blood stem cell transplantation: Patients receive autologous peripheral blood stem cells
|
|---|---|---|
|
Five-Year Overall Survival
|
63 percentage of participants
Interval 38.0 to 80.0
|
75 percentage of participants
Interval 60.0 to 84.0
|
Adverse Events
Arm I (ACT)
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Arm II (STAMP V)
Serious events: 0 serious events
Other events: 50 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm I (ACT)
n=21 participants at risk
Patients receive 41.25 mg/m2 of doxorubicin IV over 24 hours on days -9 to -6, 100 mg/kg of cyclophosphamide IV over 2 hours on day -5, and 725 mg/m2 of paclitaxel IV over 24 hours on day -4. PBSC are reinfused on days -2 and 0. G-CSF at 5 ug/kg IV is administered beginning on day 0 and continuing until blood counts recover.
filgrastim: Given IV or subcutaneously
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV
peripheral blood stem cell transplantation: Patients receive autologous peripheral blood stem cells
|
Arm II (STAMP V)
n=51 participants at risk
Patients receive cyclophosphamide 1.5 g/m2/day IV, carboplatin 200 mg/m2/day IV, and thiotepa 125 mg/m2/day IV over 24 hours on days -7 to -4. PBSC are reinfused on day -2 and 0 and G-CSF at 5ug/kg IV is administered as in arm I.
filgrastim: Given IV or subcutaneously
carboplatin: Given IV
cyclophosphamide: Given IV
thiotepa: Given IV
peripheral blood stem cell transplantation: Patients receive autologous peripheral blood stem cells
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea associated with graft versus host disease (GVHD) for BMT studies
|
90.5%
19/21 • Number of events 19 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
47.1%
24/51 • Number of events 24 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Haematemesis
|
14.3%
3/21 • Number of events 3 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.9%
2/51 • Number of events 2 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC) for BMT studies, if specified in the protocol.
|
100.0%
21/21 • Number of events 21 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
96.1%
49/51 • Number of events 49 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Blood and lymphatic system disorders
Platelets for BMT studies, if specified in the protocol.
|
100.0%
21/21 • Number of events 21 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
94.1%
48/51 • Number of events 49 • Adverse events were collected over a period of 8 years.
"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/dermatitis associated with high-dose chemotherapy or BMT studies.
|
4.8%
1/21 • Number of events 1 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
29.4%
15/51 • Number of events 15 • Adverse events were collected over a period of 8 years.
"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/desquamation associated with graft versus host disease (GVHD) for BMT studies
|
52.4%
11/21 • Number of events 11 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
17/51 • Number of events 17 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Stomatitis/pharyngitis (oral/pharyngeal mucositis) for BMT studies, if specified in the protocol.
|
90.5%
19/21 • Number of events 19 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
72.5%
37/51 • Number of events 37 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Blood and lymphatic system disorders
Transfusion: Platelets for BMT studies, if specified in the protocol.
|
95.2%
20/21 • Number of events 20 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
86.3%
44/51 • Number of events 44 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Blood and lymphatic system disorders
Transfusion: pRBCs for BMT studies, if specified in the protocol.
|
95.2%
20/21 • Number of events 20 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
86.3%
44/51 • Number of events 44 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/21 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
2.0%
1/51 • Number of events 1 • Adverse events were collected over a period of 8 years.
"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
|
90.5%
19/21 • Number of events 19 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
52.9%
27/51 • Number of events 27 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Blood and lymphatic system disorders
Haemorrhage NOS
|
9.5%
2/21 • Number of events 2 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.9%
2/51 • Number of events 2 • Adverse events were collected over a period of 8 years.
"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
|
100.0%
21/21 • Number of events 21 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
96.1%
49/51 • Number of events 49 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Blood and lymphatic system disorders
Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia
|
33.3%
7/21 • Number of events 7 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
13.7%
7/51 • Number of events 7 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Blood and lymphatic system disorders
Lymphangiopathy NOS
|
0.00%
0/21 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
2.0%
1/51 • Number of events 1 • Adverse events were collected over a period of 8 years.
"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
|
4.8%
1/21 • Number of events 1 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/51 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/21 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
2.0%
1/51 • Number of events 1 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.00%
0/21 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
2.0%
1/51 • Number of events 1 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Cardiac disorder
|
4.8%
1/21 • Number of events 1 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
2.0%
1/51 • Number of events 1 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Left ventricular failure
|
47.6%
10/21 • Number of events 10 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
13.7%
7/51 • Number of events 7 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Myocardial ischemia
|
9.5%
2/21 • Number of events 2 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/51 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Palpitations
|
28.6%
6/21 • Number of events 6 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
2.0%
1/51 • Number of events 1 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Sinus tachycardia
|
61.9%
13/21 • Number of events 13 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
35.3%
18/51 • Number of events 18 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Ventricular arrhythmia
|
4.8%
1/21 • Number of events 1 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/51 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Ear and labyrinth disorders
Ear disorder
|
4.8%
1/21 • Number of events 1 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/51 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Ear and labyrinth disorders
Ear pain
|
9.5%
2/21 • Number of events 2 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/51 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Ear and labyrinth disorders
Hearing loss
|
42.9%
9/21 • Number of events 9 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
15.7%
8/51 • Number of events 8 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Eye disorders
Conjunctival disorder
|
0.00%
0/21 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.9%
2/51 • Number of events 2 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Eye disorders
Diplopia
|
4.8%
1/21 • Number of events 1 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/51 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Eye disorders
Dry eye syndrome
|
4.8%
1/21 • Number of events 1 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
2.0%
1/51 • Number of events 1 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Eye disorders
Eye disorder
|
4.8%
1/21 • Number of events 1 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.9%
2/51 • Number of events 2 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Eye disorders
Vision blurred
|
14.3%
3/21 • Number of events 3 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/51 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
42.9%
9/21 • Number of events 9 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
54.9%
28/51 • Number of events 28 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/21 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
2.0%
1/51 • Number of events 1 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
7/21 • Number of events 7 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
39.2%
20/51 • Number of events 20 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/21 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
35.3%
18/51 • Number of events 18 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Diarrhea (Somlo COH)
|
0.00%
0/21 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
37.3%
19/51 • Number of events 19 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
9.5%
2/21 • Number of events 2 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
13.7%
7/51 • Number of events 7 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
14.3%
3/21 • Number of events 3 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
29.4%
15/51 • Number of events 15 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
4.8%
1/21 • Number of events 1 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/51 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Dysphagia, esophagitis, odynophagia (Somlo COH)
|
90.5%
19/21 • Number of events 19 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
15.7%
8/51 • Number of events 8 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Esophagitis
|
90.5%
19/21 • Number of events 19 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
17.6%
9/51 • Number of events 9 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Flatulence
|
4.8%
1/21 • Number of events 1 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
5.9%
3/51 • Number of events 3 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Gastritis
|
4.8%
1/21 • Number of events 1 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/51 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
9.5%
2/21 • Number of events 2 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
29.4%
15/51 • Number of events 23 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Haematochezia
|
4.8%
1/21 • Number of events 1 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.8%
4/51 • Number of events 4 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Incontinence NOS
|
4.8%
1/21 • Number of events 1 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.9%
2/51 • Number of events 2 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Melaena
|
4.8%
1/21 • Number of events 1 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
2.0%
1/51 • Number of events 1 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Nausea
|
95.2%
20/21 • Number of events 20 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
96.1%
49/51 • Number of events 49 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Nausea (Somlo COH)
|
0.00%
0/21 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
43.1%
22/51 • Number of events 22 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/21 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.8%
4/51 • Number of events 5 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Rectal pain
|
9.5%
2/21 • Number of events 2 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
9.8%
5/51 • Number of events 5 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Stomatitis/phayngitis (Somlo COH)
|
95.2%
20/21 • Number of events 20 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
62.7%
32/51 • Number of events 32 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Vomiting
|
100.0%
21/21 • Number of events 21 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
94.1%
48/51 • Number of events 48 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Vomiting (Somlo COH)
|
0.00%
0/21 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
43.1%
22/51 • Number of events 22 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Chest pain
|
9.5%
2/21 • Number of events 2 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
9.8%
5/51 • Number of events 5 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Chills
|
66.7%
14/21 • Number of events 14 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
43.1%
22/51 • Number of events 22 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Edema
|
0.00%
0/21 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
2.0%
1/51 • Number of events 1 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Fatigue
|
85.7%
18/21 • Number of events 18 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
94.1%
48/51 • Number of events 48 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Fever
|
4.8%
1/21 • Number of events 1 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
21.6%
11/51 • Number of events 11 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
General symptom
|
0.00%
0/21 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
2.0%
1/51 • Number of events 1 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Injection site reaction
|
4.8%
1/21 • Number of events 1 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
21.6%
11/51 • Number of events 11 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Oedema NOS
|
66.7%
14/21 • Number of events 15 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
52.9%
27/51 • Number of events 27 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Pain
|
61.9%
13/21 • Number of events 19 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
45.1%
23/51 • Number of events 39 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/21 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.9%
2/51 • Number of events 2 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Immune system disorders
Immune system disorder
|
0.00%
0/21 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
2.0%
1/51 • Number of events 1 • Adverse events were collected over a period of 8 years.
"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
|
9.5%
2/21 • Number of events 2 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
5.9%
3/51 • Number of events 4 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Infection
|
0.00%
0/21 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
2.0%
1/51 • Number of events 2 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Infection (documented clinically or microbiologically) with grade 3 or 4 neutropenia
|
4.8%
1/21 • Number of events 1 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
13.7%
7/51 • Number of events 7 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Infection NOS
|
9.5%
2/21 • Number of events 2 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
5.9%
3/51 • Number of events 3 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Infection, Bacterial (COH)
|
0.00%
0/21 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.9%
2/51 • Number of events 2 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Infection, Fungal (COH)
|
0.00%
0/21 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
2.0%
1/51 • Number of events 1 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Infection, Viral (COH)
|
0.00%
0/21 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
5.9%
3/51 • Number of events 3 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Wound infection
|
0.00%
0/21 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.9%
2/51 • Number of events 2 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/21 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.9%
2/51 • Number of events 2 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
0.00%
0/21 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
2.0%
1/51 • Number of events 1 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/21 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
2.0%
1/51 • Number of events 1 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
ADH abnormal
|
0.00%
0/21 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.9%
2/51 • Number of events 2 • Adverse events were collected over a period of 8 years.
"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
|
61.9%
13/21 • Number of events 13 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
35.3%
18/51 • Number of events 18 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Alanine aminotransferase increased
|
71.4%
15/21 • Number of events 15 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
47.1%
24/51 • Number of events 24 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Alk Phos (Somlo COH)
|
0.00%
0/21 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
15.7%
8/51 • Number of events 8 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Alkaline phosphatase increased
|
61.9%
13/21 • Number of events 13 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
17.6%
9/51 • Number of events 9 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
61.9%
13/21 • Number of events 13 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
37.3%
19/51 • Number of events 19 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Creatinine increased
|
0.00%
0/21 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.9%
2/51 • Number of events 2 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Electrocardiogram QTc interval prolonged
|
4.8%
1/21 • Number of events 1 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/51 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Hyperbilirubinemia
|
4.8%
1/21 • Number of events 1 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.9%
2/51 • Number of events 2 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Hypercholesterolemia
|
81.0%
17/21 • Number of events 17 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
23.5%
12/51 • Number of events 12 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
INR increased
|
76.2%
16/21 • Number of events 16 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
68.6%
35/51 • Number of events 35 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Leukocyte count decreased
|
0.00%
0/21 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
2.0%
1/51 • Number of events 1 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Lymphopenia
|
61.9%
13/21 • Number of events 13 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
76.5%
39/51 • Number of events 39 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/21 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.9%
2/51 • Number of events 2 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Neutrophils (ANC) (Somlo COH)
|
90.5%
19/21 • Number of events 19 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
90.2%
46/51 • Number of events 46 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC) for BMT studies, if specified in the protocol.
|
100.0%
21/21 • Number of events 21 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
90.2%
46/51 • Number of events 46 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Platelet count decreased
|
0.00%
0/21 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
2.0%
1/51 • Number of events 1 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Platelets (Somlo COH)
|
90.5%
19/21 • Number of events 19 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
90.2%
46/51 • Number of events 46 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
SGOT (Somlo COH)
|
0.00%
0/21 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
19.6%
10/51 • Number of events 10 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
SGPT (Somlo COH)
|
0.00%
0/21 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
23.5%
12/51 • Number of events 12 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Serum cholesterol increased
|
0.00%
0/21 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
2.0%
1/51 • Number of events 1 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Weight gain
|
28.6%
6/21 • Number of events 6 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
17/51 • Number of events 17 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Weight loss
|
33.3%
7/21 • Number of events 7 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.5%
13/51 • Number of events 13 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/21 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
2.0%
1/51 • Number of events 1 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
90.5%
19/21 • Number of events 19 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
92.2%
47/51 • Number of events 47 • Adverse events were collected over a period of 8 years.
"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
|
14.3%
3/21 • Number of events 3 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
9.8%
5/51 • Number of events 5 • Adverse events were collected over a period of 8 years.
"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
|
0.00%
0/21 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
2.0%
1/51 • Number of events 1 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
14.3%
3/21 • Number of events 3 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.9%
2/51 • Number of events 2 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/21 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
9.8%
5/51 • Number of events 5 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
85.7%
18/21 • Number of events 18 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
88.2%
45/51 • Number of events 45 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
9.5%
2/21 • Number of events 2 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
5.9%
3/51 • Number of events 3 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
4.8%
1/21 • Number of events 1 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
13.7%
7/51 • Number of events 7 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/21 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.9%
2/51 • Number of events 2 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
9.5%
2/21 • Number of events 2 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
2.0%
1/51 • Number of events 1 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
4.8%
1/21 • Number of events 1 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
2.0%
1/51 • Number of events 1 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
47.6%
10/21 • Number of events 10 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
78.4%
40/51 • Number of events 40 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
100.0%
21/21 • Number of events 21 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
88.2%
45/51 • Number of events 45 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
9.5%
2/21 • Number of events 2 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
9.8%
5/51 • Number of events 5 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
100.0%
21/21 • Number of events 21 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
58.8%
30/51 • Number of events 30 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
52.4%
11/21 • Number of events 11 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
23.5%
12/51 • Number of events 12 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
95.2%
20/21 • Number of events 20 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
66.7%
34/51 • Number of events 34 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
81.0%
17/21 • Number of events 17 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
84.3%
43/51 • Number of events 43 • Adverse events were collected over a period of 8 years.
"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
|
0.00%
0/21 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
2.0%
1/51 • Number of events 1 • Adverse events were collected over a period of 8 years.
"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
|
0.00%
0/21 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
2.0%
1/51 • Number of events 1 • Adverse events were collected over a period of 8 years.
"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
|
0.00%
0/21 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
2.0%
1/51 • Number of events 1 • Adverse events were collected over a period of 8 years.
"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
|
0.00%
0/21 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
2.0%
1/51 • Number of events 1 • Adverse events were collected over a period of 8 years.
"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
|
0.00%
0/21 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.9%
2/51 • Number of events 2 • Adverse events were collected over a period of 8 years.
"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
|
0.00%
0/21 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
2.0%
1/51 • Number of events 1 • Adverse events were collected over a period of 8 years.
"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
|
57.1%
12/21 • Number of events 12 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
19.6%
10/51 • Number of events 10 • Adverse events were collected over a period of 8 years.
"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
|
19.0%
4/21 • Number of events 4 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.8%
4/51 • Number of events 4 • Adverse events were collected over a period of 8 years.
"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
|
14.3%
3/21 • Number of events 3 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
9.8%
5/51 • Number of events 5 • Adverse events were collected over a period of 8 years.
"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
|
0.00%
0/21 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
2.0%
1/51 • Number of events 1 • Adverse events were collected over a period of 8 years.
"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
|
52.4%
11/21 • Number of events 11 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
17.6%
9/51 • Number of events 9 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Treatment related secondary malignancy
|
0.00%
0/21 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
2.0%
1/51 • Number of events 2 • Adverse events were collected over a period of 8 years.
"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
|
19.0%
4/21 • Number of events 4 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.8%
4/51 • Number of events 4 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Dizziness
|
33.3%
7/21 • Number of events 7 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
31.4%
16/51 • Number of events 16 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Extrapyramidal disorder
|
9.5%
2/21 • Number of events 2 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
9.8%
5/51 • Number of events 5 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Headache
|
66.7%
14/21 • Number of events 14 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
62.7%
32/51 • Number of events 32 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Neuralgia
|
38.1%
8/21 • Number of events 9 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
2.0%
1/51 • Number of events 1 • Adverse events were collected over a period of 8 years.
"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
|
14.3%
3/21 • Number of events 3 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.8%
4/51 • Number of events 4 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Olfactory nerve disorder
|
0.00%
0/21 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
2.0%
1/51 • Number of events 1 • Adverse events were collected over a period of 8 years.
"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
|
33.3%
7/21 • Number of events 7 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
5.9%
3/51 • Number of events 3 • Adverse events were collected over a period of 8 years.
"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
|
81.0%
17/21 • Number of events 17 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
11.8%
6/51 • Number of events 7 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Pyramidal tract syndrome
|
4.8%
1/21 • Number of events 1 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/51 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Syncope
|
4.8%
1/21 • Number of events 1 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.9%
2/51 • Number of events 2 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Taste alteration
|
28.6%
6/21 • Number of events 6 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
23.5%
12/51 • Number of events 12 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Tremor
|
4.8%
1/21 • Number of events 1 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
2.0%
1/51 • Number of events 1 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Anxiety
|
71.4%
15/21 • Number of events 15 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
45.1%
23/51 • Number of events 24 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Confusion
|
28.6%
6/21 • Number of events 6 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.8%
4/51 • Number of events 4 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Depression
|
28.6%
6/21 • Number of events 6 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
17/51 • Number of events 17 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Euphoria
|
0.00%
0/21 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
2.0%
1/51 • Number of events 1 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Hallucination NOS
|
23.8%
5/21 • Number of events 5 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.9%
2/51 • Number of events 2 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Insomnia
|
33.3%
7/21 • Number of events 7 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
52.9%
27/51 • Number of events 27 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Psychosis
|
4.8%
1/21 • Number of events 1 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/51 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Bladder pain
|
0.00%
0/21 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.8%
4/51 • Number of events 4 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Bladder spasm
|
0.00%
0/21 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
2.0%
1/51 • Number of events 1 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Blood urine present
|
14.3%
3/21 • Number of events 3 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
17.6%
9/51 • Number of events 9 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/21 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
2.0%
1/51 • Number of events 1 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Urinary retention
|
9.5%
2/21 • Number of events 2 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
2.0%
1/51 • Number of events 1 • Adverse events were collected over a period of 8 years.
"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
|
9.5%
2/21 • Number of events 2 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
5.9%
3/51 • Number of events 4 • Adverse events were collected over a period of 8 years.
"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
|
4.8%
1/21 • Number of events 1 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/51 • Adverse events were collected over a period of 8 years.
"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
|
14.3%
3/21 • Number of events 3 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/51 • Adverse events were collected over a period of 8 years.
"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 inflammation
|
0.00%
0/21 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
2.0%
1/51 • Number of events 1 • Adverse events were collected over a period of 8 years.
"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
|
4.8%
1/21 • Number of events 1 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
9.8%
5/51 • Number of events 5 • Adverse events were collected over a period of 8 years.
"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
|
28.6%
6/21 • Number of events 6 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
23.5%
12/51 • Number of events 12 • Adverse events were collected over a period of 8 years.
"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
|
19.0%
4/21 • Number of events 4 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
17.6%
9/51 • Number of events 9 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
4.8%
1/21 • Number of events 1 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
2.0%
1/51 • Number of events 1 • Adverse events were collected over a period of 8 years.
"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
|
33.3%
7/21 • Number of events 7 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
21.6%
11/51 • Number of events 11 • Adverse events were collected over a period of 8 years.
"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
|
14.3%
3/21 • Number of events 3 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.8%
4/51 • Number of events 4 • Adverse events were collected over a period of 8 years.
"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
|
9.5%
2/21 • Number of events 2 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
13.7%
7/51 • Number of events 7 • Adverse events were collected over a period of 8 years.
"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
|
9.5%
2/21 • Number of events 2 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
2.0%
1/51 • Number of events 1 • Adverse events were collected over a period of 8 years.
"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
|
0.00%
0/21 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.9%
2/51 • Number of events 2 • Adverse events were collected over a period of 8 years.
"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
|
9.5%
2/21 • Number of events 2 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
21.6%
11/51 • Number of events 14 • Adverse events were collected over a period of 8 years.
"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
|
0.00%
0/21 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
2.0%
1/51 • Number of events 1 • Adverse events were collected over a period of 8 years.
"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
|
76.2%
16/21 • Number of events 16 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
37.3%
19/51 • Number of events 19 • Adverse events were collected over a period of 8 years.
"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
|
4.8%
1/21 • Number of events 1 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
5.9%
3/51 • Number of events 3 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/21 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.9%
2/51 • Number of events 2 • Adverse events were collected over a period of 8 years.
"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
|
0.00%
0/21 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
2.0%
1/51 • Number of events 1 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/21 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
2.0%
1/51 • Number of events 1 • Adverse events were collected over a period of 8 years.
"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
|
28.6%
6/21 • Number of events 6 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
13.7%
7/51 • Number of events 7 • Adverse events were collected over a period of 8 years.
"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
|
52.4%
11/21 • Number of events 11 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
15.7%
8/51 • Number of events 8 • Adverse events were collected over a period of 8 years.
"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
|
0.00%
0/21 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
5.9%
3/51 • Number of events 3 • Adverse events were collected over a period of 8 years.
"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 discolouration
|
0.00%
0/21 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.9%
2/51 • Number of events 2 • Adverse events were collected over a period of 8 years.
"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
|
52.4%
11/21 • Number of events 15 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
35.3%
18/51 • Number of events 20 • Adverse events were collected over a period of 8 years.
"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
|
19.0%
4/21 • Number of events 4 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
5.9%
3/51 • Number of events 3 • Adverse events were collected over a period of 8 years.
"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
|
4.8%
1/21 • Number of events 1 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
2.0%
1/51 • Number of events 1 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Flushing
|
28.6%
6/21 • Number of events 6 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.5%
13/51 • Number of events 13 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Hemorrhage
|
4.8%
1/21 • Number of events 1 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.8%
4/51 • Number of events 4 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Hot flashes
|
4.8%
1/21 • Number of events 1 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
2.0%
1/51 • Number of events 1 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Hypertension
|
23.8%
5/21 • Number of events 5 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
9.8%
5/51 • Number of events 5 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Hypotension
|
66.7%
14/21 • Number of events 14 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
51.0%
26/51 • Number of events 26 • Adverse events were collected over a period of 8 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
Additional Information
Paul Frankel, Ph.D.
City of Hope National Medical Center
Phone: (626) 256-4673
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place