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=5 Participants	51 years n=7 Participants	50 years n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	51 Participants n=7 Participants	72 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants	51 participants n=7 Participants	72 participants n=5 Participants

PRIMARY outcome

Timeframe: Five years

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.

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 Years

Patients 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 II (STAMP V)

Serious events: 0 serious events

Other events: 50 other events

Deaths: 0 deaths

Arm I (ACT)

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	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	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
Gastrointestinal disorders Diarrhea associated with graft versus host disease (GVHD) for BMT studies	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.	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.
Gastrointestinal disorders Haematemesis	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.	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.
Blood and lymphatic system disorders Leukocytes (total WBC) for BMT studies, if specified in the protocol.	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.	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.
Blood and lymphatic system disorders Platelets for BMT studies, if specified in the protocol.	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.	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.
Skin and subcutaneous tissue disorders Rash/dermatitis associated with high-dose chemotherapy or BMT studies.	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.	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.
Skin and subcutaneous tissue disorders Rash/desquamation associated with graft versus host disease (GVHD) for BMT studies	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.	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.
Gastrointestinal disorders Stomatitis/pharyngitis (oral/pharyngeal mucositis) for BMT studies, if specified in the protocol.	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.	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.
Blood and lymphatic system disorders Transfusion: Platelets for BMT studies, if specified in the protocol.	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.	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.
Blood and lymphatic system disorders Transfusion: pRBCs for BMT studies, if specified in the protocol.	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.	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.
Blood and lymphatic system disorders Disseminated intravascular coagulation	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.	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.
Blood and lymphatic system disorders Febrile neutropenia	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.	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.
Blood and lymphatic system disorders Haemorrhage NOS	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.	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.
Blood and lymphatic system disorders Hemoglobin decreased	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.	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.
Blood and lymphatic system disorders Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia	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.	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.
Blood and lymphatic system disorders Lymphangiopathy NOS	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.	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.
Blood and lymphatic system disorders Lymphatic disorder	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.	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.
Cardiac disorders Arrhythmia	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.	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.
Cardiac disorders Arrhythmia supraventricular	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.	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.
Cardiac disorders Cardiac disorder	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.	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.
Cardiac disorders Left ventricular failure	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.	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.
Cardiac disorders Myocardial ischemia	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.	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.
Cardiac disorders Palpitations	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.	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.
Cardiac disorders Sinus tachycardia	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.	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.
Cardiac disorders Ventricular arrhythmia	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.	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.
Ear and labyrinth disorders Ear disorder	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.	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.
Ear and labyrinth disorders Ear pain	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.	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.
Ear and labyrinth disorders Hearing loss	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.	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.
Eye disorders Conjunctival disorder	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.	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.
Eye disorders Diplopia	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.	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.
Eye disorders Dry eye syndrome	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.	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.
Eye disorders Eye disorder	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.	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.
Eye disorders Vision blurred	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.	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.
Gastrointestinal disorders Abdominal pain	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.	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.
Gastrointestinal disorders Colitis	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.	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.
Gastrointestinal disorders Constipation	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.	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.
Gastrointestinal disorders Diarrhea	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.	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.
Gastrointestinal disorders Diarrhea (Somlo COH)	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.	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.
Gastrointestinal disorders Dry mouth	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.	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.
Gastrointestinal disorders Dyspepsia	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.	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.
Gastrointestinal disorders Dysphagia	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.	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.
Gastrointestinal disorders Dysphagia, esophagitis, odynophagia (Somlo COH)	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.	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.
Gastrointestinal disorders Esophagitis	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.	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.
Gastrointestinal disorders Flatulence	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.	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.
Gastrointestinal disorders Gastritis	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.	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.
Gastrointestinal disorders Gastrointestinal disorder	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.	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.
Gastrointestinal disorders Haematochezia	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.	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.
Gastrointestinal disorders Incontinence NOS	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.	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.
Gastrointestinal disorders Melaena	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.	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.
Gastrointestinal disorders Nausea	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.	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.
Gastrointestinal disorders Nausea (Somlo COH)	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.	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.
Gastrointestinal disorders Proctitis	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.	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.
Gastrointestinal disorders Rectal pain	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.	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.
Gastrointestinal disorders Stomatitis/phayngitis (Somlo COH)	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.	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.
Gastrointestinal disorders Vomiting	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.	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.
Gastrointestinal disorders Vomiting (Somlo COH)	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.	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.
General disorders Chest pain	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.	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.
General disorders Chills	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.	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.
General disorders Edema	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.	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.
General disorders Fatigue	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.	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.
General disorders Fever	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.	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.
General disorders General symptom	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.	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.
General disorders Injection site reaction	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.	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.
General disorders Oedema NOS	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.	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.
General disorders Pain	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.	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.
Immune system disorders Hypersensitivity	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.	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.
Immune system disorders Immune system disorder	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.	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.
Infections and infestations Catheter related infection	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.	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.
Infections and infestations Infection	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.	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.
Infections and infestations Infection (documented clinically or microbiologically) with grade 3 or 4 neutropenia	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.	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.
Infections and infestations Infection NOS	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.	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.
Infections and infestations Infection, Bacterial (COH)	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.	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.
Infections and infestations Infection, Fungal (COH)	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.	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.
Infections and infestations Infection, Viral (COH)	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.	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.
Infections and infestations Wound infection	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.	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.
Injury, poisoning and procedural complications Bruising	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.	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.
Injury, poisoning and procedural complications Dermatitis radiation	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.	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.
Injury, poisoning and procedural complications Wound dehiscence	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.	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.
Investigations ADH abnormal	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.	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.
Investigations Activated partial thromboplastin time prolonged	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.	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.
Investigations Alanine aminotransferase increased	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.	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.
Investigations Alk Phos (Somlo COH)	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.	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.
Investigations Alkaline phosphatase increased	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.	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.
Investigations Aspartate aminotransferase increased	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.	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.
Investigations Creatinine increased	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.	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.
Investigations Electrocardiogram QTc interval prolonged	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.	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.
Investigations Hyperbilirubinemia	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.	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.
Investigations Hypercholesterolemia	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.	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.
Investigations INR increased	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.	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.
Investigations Leukocyte count decreased	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.	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.
Investigations Lymphopenia	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.	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.
Investigations Neutrophil count decreased	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.	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.
Investigations Neutrophils (ANC) (Somlo COH)	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.	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.
Investigations Neutrophils/granulocytes (ANC/AGC) for BMT studies, if specified in the protocol.	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.	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.
Investigations Platelet count decreased	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.	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.
Investigations Platelets (Somlo COH)	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.	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.
Investigations SGOT (Somlo COH)	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.	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.
Investigations SGPT (Somlo COH)	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.	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.
Investigations Serum cholesterol increased	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.	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.
Investigations Weight gain	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.	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.
Investigations Weight loss	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.	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.
Metabolism and nutrition disorders Acidosis	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.	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.
Metabolism and nutrition disorders Anorexia	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.	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.
Metabolism and nutrition disorders Blood bicarbonate decreased	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.	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.
Metabolism and nutrition disorders Blood glucose increased	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.	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.
Metabolism and nutrition disorders Dehydration	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.	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.
Metabolism and nutrition disorders Hypercalcemia	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.	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.
Metabolism and nutrition disorders Hyperglycemia	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.	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.
Metabolism and nutrition disorders Hyperkalemia	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.	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.
Metabolism and nutrition disorders Hypermagnesemia	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.	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.
Metabolism and nutrition disorders Hypernatremia	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.	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.
Metabolism and nutrition disorders Hypertriglyceridemia	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.	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.
Metabolism and nutrition disorders Hyperuricemia	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.	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.
Metabolism and nutrition disorders Hypoalbuminemia	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.	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.
Metabolism and nutrition disorders Hypocalcemia	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.	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.
Metabolism and nutrition disorders Hypoglycemia	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.	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.
Metabolism and nutrition disorders Hypokalemia	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.	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.
Metabolism and nutrition disorders Hypomagnesemia	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.	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.
Metabolism and nutrition disorders Hyponatremia	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.	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.
Metabolism and nutrition disorders Hypophosphatemia	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.	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.
Metabolism and nutrition disorders Serum albumin decreased	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.	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.
Metabolism and nutrition disorders Serum calcium decreased	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.	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.
Metabolism and nutrition disorders Serum magnesium decreased	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.	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.
Metabolism and nutrition disorders Serum phosphate decreased	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.	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.
Metabolism and nutrition disorders Serum potassium decreased	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.	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.
Metabolism and nutrition disorders Serum sodium decreased	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.	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.
Musculoskeletal and connective tissue disorders Bone pain	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.	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.
Musculoskeletal and connective tissue disorders Joint pain	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.	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.
Musculoskeletal and connective tissue disorders Muscle weakness	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.	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.
Musculoskeletal and connective tissue disorders Musculoskeletal disorder	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.	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.
Musculoskeletal and connective tissue disorders Myalgia	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.	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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Treatment related secondary malignancy	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.	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.
Nervous system disorders Depressed level of consciousness	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.	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.
Nervous system disorders Dizziness	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.	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.
Nervous system disorders Extrapyramidal disorder	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.	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.
Nervous system disorders Headache	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.	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.
Nervous system disorders Neuralgia	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.	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.
Nervous system disorders Neurological disorder NOS	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.	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.
Nervous system disorders Olfactory nerve disorder	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.	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.
Nervous system disorders Peripheral motor neuropathy	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.	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.
Nervous system disorders Peripheral sensory neuropathy	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.	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.
Nervous system disorders Pyramidal tract syndrome	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.	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.
Nervous system disorders Syncope	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.	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.
Nervous system disorders Taste alteration	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.	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.
Nervous system disorders Tremor	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.	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.
Psychiatric disorders Anxiety	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.	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.
Psychiatric disorders Confusion	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.	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.
Psychiatric disorders Depression	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.	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.
Psychiatric disorders Euphoria	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.	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.
Psychiatric disorders Hallucination NOS	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.	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.
Psychiatric disorders Insomnia	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.	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.
Psychiatric disorders Psychosis	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.	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.
Renal and urinary disorders Bladder pain	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.	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.
Renal and urinary disorders Bladder spasm	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.	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.
Renal and urinary disorders Blood urine present	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.	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.
Renal and urinary disorders Urinary frequency	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.	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.
Renal and urinary disorders Urinary retention	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.	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.
Renal and urinary disorders Urogenital disorder	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.	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.
Reproductive system and breast disorders Irregular menstruation	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.	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.
Reproductive system and breast disorders Vaginal hemorrhage	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.	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.
Reproductive system and breast disorders Vaginal inflammation	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.	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.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	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.	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.
Respiratory, thoracic and mediastinal disorders Cough	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.	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.
Respiratory, thoracic and mediastinal disorders Dyspnea	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.	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.
Respiratory, thoracic and mediastinal disorders Haemoptysis	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.	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.
Respiratory, thoracic and mediastinal disorders Hemorrhage nasal	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.	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.
Respiratory, thoracic and mediastinal disorders Hiccough	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.	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.
Respiratory, thoracic and mediastinal disorders Hypoxia	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.	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.
Respiratory, thoracic and mediastinal disorders Pleural effusion	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.	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.
Respiratory, thoracic and mediastinal disorders Pneumonitis	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.	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.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	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.	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.
Respiratory, thoracic and mediastinal disorders Voice alteration	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.	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.
Skin and subcutaneous tissue disorders Alopecia	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.	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.
Skin and subcutaneous tissue disorders Dry skin	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.	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.
Skin and subcutaneous tissue disorders Erythema multiforme	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.	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.
Skin and subcutaneous tissue disorders Hand-and-foot syndrome	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.	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.
Skin and subcutaneous tissue disorders Nail disorder	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.	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.
Skin and subcutaneous tissue disorders Petechiae	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.	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.
Skin and subcutaneous tissue disorders Pruritus	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.	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.
Skin and subcutaneous tissue disorders Rash desquamating	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.	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.
Skin and subcutaneous tissue disorders Skin discolouration	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.	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.
Skin and subcutaneous tissue disorders Skin disorder	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.	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.
Skin and subcutaneous tissue disorders Sweating	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.	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.
Skin and subcutaneous tissue disorders Urticaria	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.	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.
Vascular disorders Flushing	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.	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.
Vascular disorders Hemorrhage	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.	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.
Vascular disorders Hot flashes	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.	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.
Vascular disorders Hypertension	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.	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.
Vascular disorders Hypotension	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.	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.

Additional Information

Paul Frankel, Ph.D.

City of Hope National Medical Center

Phone: (626) 256-4673

Email: pfrankel@coh.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place