Trial Outcomes & Findings for Ofatumumab, High Dose Methylprednisolone, Ofatumumab and Lenalidomide Consolidative Therapy for Untreated CLL/SLL (NCT NCT01496976)
NCT ID: NCT01496976
Last Updated: 2025-12-19
Results Overview
Number of participants with complete response, the disappearance of all signs of cancer in response to treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
45 participants
Primary outcome timeframe
3 Months
Results posted on
2025-12-19
Participant Flow
Participant milestones
| Measure |
Immunotherapy
Combination Regimen Followed by Consolidative Therapy: Ofatumumab/High Dose Methylprednisolone (HDMP) plus Ofatumumab/Lenalidomide
High Dose Methylprednisolone (HDMP): HDMP will be administered at 1 gm/m\^2 IV over 90 minutes daily with ofatumumab infusions 1-8.
Ofatumumab: Ofatumumab infusion will be administered immediately after HDMP.
Lenalidomide: The Lenalidomide Starting Dose (Cycle 4) Based on Renal Function Prior to Cycle 4 of Treatment.
|
|---|---|
|
Overall Study
STARTED
|
45
|
|
Overall Study
COMPLETED
|
44
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Immunotherapy
Combination Regimen Followed by Consolidative Therapy: Ofatumumab/High Dose Methylprednisolone (HDMP) plus Ofatumumab/Lenalidomide
High Dose Methylprednisolone (HDMP): HDMP will be administered at 1 gm/m\^2 IV over 90 minutes daily with ofatumumab infusions 1-8.
Ofatumumab: Ofatumumab infusion will be administered immediately after HDMP.
Lenalidomide: The Lenalidomide Starting Dose (Cycle 4) Based on Renal Function Prior to Cycle 4 of Treatment.
|
|---|---|
|
Overall Study
Withdrew - received stem cell transplant
|
1
|
Baseline Characteristics
Ofatumumab, High Dose Methylprednisolone, Ofatumumab and Lenalidomide Consolidative Therapy for Untreated CLL/SLL
Baseline characteristics by cohort
| Measure |
Immunotherapy
n=45 Participants
Combination Regimen Followed by Consolidative Therapy: Ofatumumab/High Dose Methylprednisolone (HDMP) plus Ofatumumab/Lenalidomide
High Dose Methylprednisolone (HDMP): HDMP will be administered at 1 gm/m\^2 IV over 90 minutes daily with ofatumumab infusions 1-8.
Ofatumumab: Ofatumumab infusion will be administered immediately after HDMP.
Lenalidomide: The Lenalidomide Starting Dose (Cycle 4) Based on Renal Function Prior to Cycle 4 of Treatment.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
20 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
45 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
44 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
45 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 3 MonthsPopulation: number of evaluable participants
Number of participants with complete response, the disappearance of all signs of cancer in response to treatment.
Outcome measures
| Measure |
Immunotherapy
n=44 Participants
Combination Regimen Followed by Consolidative Therapy: Ofatumumab/High Dose Methylprednisolone (HDMP) plus Ofatumumab/Lenalidomide
High Dose Methylprednisolone (HDMP): HDMP will be administered at 1 gm/m\^2 IV over 90 minutes daily with ofatumumab infusions 1-8.
Ofatumumab: Ofatumumab infusion will be administered immediately after HDMP.
Lenalidomide: The Lenalidomide Starting Dose (Cycle 4) Based on Renal Function Prior to Cycle 4 of Treatment.
|
|---|---|
|
Number of Participants With Complete Response (CR)
|
1 Participants
|
PRIMARY outcome
Timeframe: 3 MonthsThe primary endpoint for this trial is the combined complete and partial response rate to the protocol therapy at 3 months, which is also the end of Cycle 3. The objective response (CR+PR) rate will be summarized using both a point estimate and its exact confidence interval based on the binomial distribution.
Outcome measures
| Measure |
Immunotherapy
n=44 Participants
Combination Regimen Followed by Consolidative Therapy: Ofatumumab/High Dose Methylprednisolone (HDMP) plus Ofatumumab/Lenalidomide
High Dose Methylprednisolone (HDMP): HDMP will be administered at 1 gm/m\^2 IV over 90 minutes daily with ofatumumab infusions 1-8.
Ofatumumab: Ofatumumab infusion will be administered immediately after HDMP.
Lenalidomide: The Lenalidomide Starting Dose (Cycle 4) Based on Renal Function Prior to Cycle 4 of Treatment.
|
|---|---|
|
Number of Participants With Partial Response (PR)
|
33 participants
|
SECONDARY outcome
Timeframe: Up to 56 monthsPopulation: evaluable participants
Progression-free survival (PFS), defined as the time from study entry to disease progression, relapse or death due to any cause, whichever is earlier.
Outcome measures
| Measure |
Immunotherapy
n=24 Participants
Combination Regimen Followed by Consolidative Therapy: Ofatumumab/High Dose Methylprednisolone (HDMP) plus Ofatumumab/Lenalidomide
High Dose Methylprednisolone (HDMP): HDMP will be administered at 1 gm/m\^2 IV over 90 minutes daily with ofatumumab infusions 1-8.
Ofatumumab: Ofatumumab infusion will be administered immediately after HDMP.
Lenalidomide: The Lenalidomide Starting Dose (Cycle 4) Based on Renal Function Prior to Cycle 4 of Treatment.
|
|---|---|
|
Rate of Progression/Relapse Free Survival (PFS)
|
54.4 months
Interval 2.9 to 77.6
|
SECONDARY outcome
Timeframe: 36 MonthsPopulation: evaluable participants
Overall survival will be summarized with the Kaplan-Meier curve.
Outcome measures
| Measure |
Immunotherapy
n=24 Participants
Combination Regimen Followed by Consolidative Therapy: Ofatumumab/High Dose Methylprednisolone (HDMP) plus Ofatumumab/Lenalidomide
High Dose Methylprednisolone (HDMP): HDMP will be administered at 1 gm/m\^2 IV over 90 minutes daily with ofatumumab infusions 1-8.
Ofatumumab: Ofatumumab infusion will be administered immediately after HDMP.
Lenalidomide: The Lenalidomide Starting Dose (Cycle 4) Based on Renal Function Prior to Cycle 4 of Treatment.
|
|---|---|
|
Number of Participants With Overall Survival (OS)
|
24 participants
|
Adverse Events
Immunotherapy
Serious events: 11 serious events
Other events: 45 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Immunotherapy
n=45 participants at risk
Combination Regimen Followed by Consolidative Therapy: Ofatumumab/High Dose Methylprednisolone (HDMP) plus Ofatumumab/Lenalidomide
High Dose Methylprednisolone (HDMP): HDMP will be administered at 1 gm/m\^2 IV over 90 minutes daily with ofatumumab infusions 1-8.
Ofatumumab: Ofatumumab infusion will be administered immediately after HDMP.
Lenalidomide: The Lenalidomide Starting Dose (Cycle 4) Based on Renal Function Prior to Cycle 4 of Treatment.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
8.9%
4/45 • Number of events 4 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
General disorders
Fever
|
4.4%
2/45 • Number of events 4 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Infections and infestations
Infections and infestations - Other
|
2.2%
1/45 • Number of events 1 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
4.4%
2/45 • Number of events 3 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
2.2%
1/45 • Number of events 1 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Infections and infestations
Lung infection
|
2.2%
1/45 • Number of events 1 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.2%
1/45 • Number of events 1 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Renal and urinary disorders
Acute kidney injury
|
4.4%
2/45 • Number of events 2 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
2.2%
1/45 • Number of events 1 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Cardiac disorders
Cardiac arrest
|
2.2%
1/45 • Number of events 1 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
General disorders
Non-cardiac chest pain
|
2.2%
1/45 • Number of events 1 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Immune system disorders
Allergic Reaction
|
2.2%
1/45 • Number of events 1 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Gastrointestinal disorders
Diverticulitis
|
2.2%
1/45 • Number of events 1 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
General disorders
Pain
|
2.2%
1/45 • Number of events 2 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
Other adverse events
| Measure |
Immunotherapy
n=45 participants at risk
Combination Regimen Followed by Consolidative Therapy: Ofatumumab/High Dose Methylprednisolone (HDMP) plus Ofatumumab/Lenalidomide
High Dose Methylprednisolone (HDMP): HDMP will be administered at 1 gm/m\^2 IV over 90 minutes daily with ofatumumab infusions 1-8.
Ofatumumab: Ofatumumab infusion will be administered immediately after HDMP.
Lenalidomide: The Lenalidomide Starting Dose (Cycle 4) Based on Renal Function Prior to Cycle 4 of Treatment.
|
|---|---|
|
Investigations
Weight gain
|
4.4%
2/45 • Number of events 2 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Investigations
Lymphocyte count increased
|
2.2%
1/45 • Number of events 1 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Investigations
Urine output decreased
|
2.2%
1/45 • Number of events 1 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Gastrointestinal disorders
Anal pain
|
2.2%
1/45 • Number of events 1 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Gastrointestinal disorders
Gastritis
|
2.2%
1/45 • Number of events 4 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Gastrointestinal disorders
Hemorrhoids
|
2.2%
1/45 • Number of events 2 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Gastrointestinal disorders
Mucositis oral
|
2.2%
1/45 • Number of events 1 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Gastrointestinal disorders
Oral hemorrhage
|
2.2%
1/45 • Number of events 2 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Vascular disorders
Vascular disorders - Other
|
2.2%
1/45 • Number of events 1 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Blood and lymphatic system disorders
Anemia
|
26.7%
12/45 • Number of events 20 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Investigations
Platelet count decreased
|
35.6%
16/45 • Number of events 46 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Investigations
Investigations -Other
|
24.4%
11/45 • Number of events 22 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Investigations
Alanine aminotransferase increased
|
22.2%
10/45 • Number of events 24 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Investigations
Aspartate aminotransferase increased
|
17.8%
8/45 • Number of events 13 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Investigations
Lymphocycte count decreased
|
13.3%
6/45 • Number of events 7 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Investigations
Creatinine increased
|
11.1%
5/45 • Number of events 6 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Investigations
Weight loss
|
8.9%
4/45 • Number of events 6 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Investigations
Alkaline phosphatase increased
|
4.4%
2/45 • Number of events 2 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Investigations
Blood bilirubin increased
|
4.4%
2/45 • Number of events 3 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
General disorders
Fatigue
|
48.9%
22/45 • Number of events 40 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
General disorders
Pain
|
40.0%
18/45 • Number of events 30 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
General disorders
Infusion related reaction
|
35.6%
16/45 • Number of events 20 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
General disorders
Edema limbs
|
31.1%
14/45 • Number of events 24 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
General disorders
Fever
|
28.9%
13/45 • Number of events 17 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
General disorders
Chills
|
26.7%
12/45 • Number of events 15 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
General disorders
Flu like symptoms
|
24.4%
11/45 • Number of events 14 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
General disorders
General disorders & administration site conditions-Other
|
15.6%
7/45 • Number of events 8 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
General disorders
Irritability
|
8.9%
4/45 • Number of events 4 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
General disorders
Non-cardiac chest pain
|
6.7%
3/45 • Number of events 4 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
General disorders
Edema face
|
4.4%
2/45 • Number of events 2 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
General disorders
Edema trunk
|
4.4%
2/45 • Number of events 7 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
General disorders
Gait disturbance
|
4.4%
2/45 • Number of events 2 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
General disorders
Injection site reaction
|
4.4%
2/45 • Number of events 2 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
General disorders
Malaise
|
4.4%
2/45 • Number of events 2 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
General disorders
Localized edema
|
2.2%
1/45 • Number of events 1 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Investigations
Neutrophil count decreased
|
82.2%
37/45 • Number of events 274 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Investigations
White blood cell decreased
|
64.4%
29/45 • Number of events 130 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders -Other
|
75.6%
34/45 • Number of events 108 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
35.6%
16/45 • Number of events 29 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
33.3%
15/45 • Number of events 21 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Metabolism and nutrition disorders
Anorexia
|
26.7%
12/45 • Number of events 15 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
15.6%
7/45 • Number of events 8 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
13.3%
6/45 • Number of events 7 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
13.3%
6/45 • Number of events 18 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
11.1%
5/45 • Number of events 9 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
8.9%
4/45 • Number of events 11 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
8.9%
4/45 • Number of events 4 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
8.9%
4/45 • Number of events 11 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Metabolism and nutrition disorders
Dehydration
|
6.7%
3/45 • Number of events 4 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
6.7%
3/45 • Number of events 4 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
4.4%
2/45 • Number of events 2 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Gastrointestinal disorders
Diarrhea
|
53.3%
24/45 • Number of events 48 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Gastrointestinal disorders
Constipation
|
44.4%
20/45 • Number of events 33 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Gastrointestinal disorders
Nausea
|
44.4%
20/45 • Number of events 33 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Gastrointestinal disorders
Dyspepsia
|
22.2%
10/45 • Number of events 15 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Gastrointestinal disorders
Abdominal Pain
|
20.0%
9/45 • Number of events 10 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
20.0%
9/45 • Number of events 9 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
9/45 • Number of events 12 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Gastrointestinal disorders
Dry mouth
|
13.3%
6/45 • Number of events 10 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Gastrointestinal disorders
Dysphagia
|
11.1%
5/45 • Number of events 5 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Gastrointestinal disorders
Flatulence
|
8.9%
4/45 • Number of events 5 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
8.9%
4/45 • Number of events 4 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Gastrointestinal disorders
Oral pain
|
8.9%
4/45 • Number of events 4 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Gastrointestinal disorders
Bloating
|
6.7%
3/45 • Number of events 4 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Gastrointestinal disorders
Stomach pain
|
6.7%
3/45 • Number of events 3 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
4.4%
2/45 • Number of events 2 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
4.4%
2/45 • Number of events 2 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Gastrointestinal disorders
Abdominal distension
|
2.2%
1/45 • Number of events 1 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
2.2%
1/45 • Number of events 1 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
48.9%
22/45 • Number of events 34 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Nervous system disorders
Headache
|
42.2%
19/45 • Number of events 32 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Nervous system disorders
Movements involuntary
|
37.8%
17/45 • Number of events 26 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Nervous system disorders
Dizziness
|
33.3%
15/45 • Number of events 23 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Nervous system disorders
Paresthesia
|
28.9%
13/45 • Number of events 27 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Nervous system disorders
Dysgeusia
|
20.0%
9/45 • Number of events 14 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Nervous system disorders
Concentration impairment
|
15.6%
7/45 • Number of events 7 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Nervous system disorders
Memory impairment
|
15.6%
7/45 • Number of events 8 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Nervous system disorders
Nervous system disorders - Other
|
13.3%
6/45 • Number of events 7 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Nervous system disorders
Tremor
|
13.3%
6/45 • Number of events 8 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Nervous system disorders
Akathisia
|
2.2%
1/45 • Number of events 1 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Nervous system disorders
Ataxia
|
2.2%
1/45 • Number of events 1 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Nervous system disorders
Dysarthria
|
2.2%
1/45 • Number of events 1 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Nervous system disorders
Dyphasia
|
2.2%
1/45 • Number of events 1 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Nervous system disorders
Lethargy
|
2.2%
1/45 • Number of events 5 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Nervous system disorders
Sinus pain
|
2.2%
1/45 • Number of events 1 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
42.2%
19/45 • Number of events 30 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
35.6%
16/45 • Number of events 25 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
33.3%
15/45 • Number of events 20 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
15/45 • Number of events 25 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
31.1%
14/45 • Number of events 18 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
13.3%
6/45 • Number of events 8 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
8.9%
4/45 • Number of events 4 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
8.9%
4/45 • Number of events 5 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
4.4%
2/45 • Number of events 2 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
2.2%
1/45 • Number of events 1 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
2.2%
1/45 • Number of events 1 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
40.0%
18/45 • Number of events 23 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
26.7%
12/45 • Number of events 19 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
26.7%
12/45 • Number of events 13 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
24.4%
11/45 • Number of events 12 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
17.8%
8/45 • Number of events 9 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
15.6%
7/45 • Number of events 8 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
13.3%
6/45 • Number of events 7 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
|
11.1%
5/45 • Number of events 5 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
6.7%
3/45 • Number of events 3 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
6.7%
3/45 • Number of events 3 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.4%
2/45 • Number of events 2 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.4%
2/45 • Number of events 2 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
4.4%
2/45 • Number of events 2 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
2.2%
1/45 • Number of events 1 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.2%
1/45 • Number of events 1 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.2%
1/45 • Number of events 1 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
2.2%
1/45 • Number of events 1 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
2.2%
1/45 • Number of events 1 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
31.1%
14/45 • Number of events 17 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
28.9%
13/45 • Number of events 14 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
26.7%
12/45 • Number of events 20 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
24.4%
11/45 • Number of events 13 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other
|
17.8%
8/45 • Number of events 13 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
15.6%
7/45 • Number of events 10 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
8.9%
4/45 • Number of events 5 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
6.7%
3/45 • Number of events 3 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
4.4%
2/45 • Number of events 3 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
4.4%
2/45 • Number of events 2 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
2.2%
1/45 • Number of events 1 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
2.2%
1/45 • Number of events 1 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
2.2%
1/45 • Number of events 1 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness right-sided
|
2.2%
1/45 • Number of events 1 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.2%
1/45 • Number of events 1 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Infections and infestations
Upper respiratory infection
|
37.8%
17/45 • Number of events 23 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Infections and infestations
Sinusitis
|
31.1%
14/45 • Number of events 16 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Infections and infestations
Infections and infestations - Other
|
20.0%
9/45 • Number of events 9 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Infections and infestations
Urinary tract infection
|
11.1%
5/45 • Number of events 6 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Infections and infestations
Rash pustular
|
4.4%
2/45 • Number of events 2 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Infections and infestations
Skin infection
|
4.4%
2/45 • Number of events 2 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Infections and infestations
Bronchial infection
|
2.2%
1/45 • Number of events 1 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Infections and infestations
Conjunctivitis infective
|
2.2%
1/45 • Number of events 1 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Infections and infestations
Eye infection
|
2.2%
1/45 • Number of events 1 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Infections and infestations
Lung infection
|
2.2%
1/45 • Number of events 2 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Infections and infestations
Mucosal infection
|
2.2%
1/45 • Number of events 1 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Infections and infestations
Otitis media
|
2.2%
1/45 • Number of events 1 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Infections and infestations
Papulopustular rash
|
2.2%
1/45 • Number of events 1 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Infections and infestations
Rhinitis infective
|
2.2%
1/45 • Number of events 1 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Infections and infestations
Tooth infection
|
2.2%
1/45 • Number of events 1 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Psychiatric disorders
Insomnia
|
68.9%
31/45 • Number of events 53 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Psychiatric disorders
Anxiety
|
20.0%
9/45 • Number of events 14 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Psychiatric disorders
Depression
|
15.6%
7/45 • Number of events 8 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Psychiatric disorders
Psychiatric disorders - Other
|
15.6%
7/45 • Number of events 9 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Psychiatric disorders
Agitation
|
8.9%
4/45 • Number of events 5 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Psychiatric disorders
Confusion
|
4.4%
2/45 • Number of events 3 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Psychiatric disorders
Euphoria
|
2.2%
1/45 • Number of events 1 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Psychiatric disorders
Libido decreased
|
2.2%
1/45 • Number of events 1 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Psychiatric disorders
Mania
|
2.2%
1/45 • Number of events 4 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Vascular disorders
Hypertension
|
42.2%
19/45 • Number of events 26 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Vascular disorders
Flushing
|
13.3%
6/45 • Number of events 9 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Vascular disorders
Hot flashes
|
11.1%
5/45 • Number of events 5 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Vascular disorders
Hypotension
|
11.1%
5/45 • Number of events 8 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Vascular disorders
Thromboembolic event
|
4.4%
2/45 • Number of events 2 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Vascular disorders
Lymphedema
|
2.2%
1/45 • Number of events 1 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Vascular disorders
Peripheral ischemia
|
2.2%
1/45 • Number of events 1 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other
|
15.6%
7/45 • Number of events 9 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Blood and lymphatic system disorders
Leukocytosis
|
11.1%
5/45 • Number of events 6 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
8.9%
4/45 • Number of events 4 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Blood and lymphatic system disorders
Lymph node pain
|
6.7%
3/45 • Number of events 5 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
2.2%
1/45 • Number of events 1 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Eye disorders
Eye disorders - Other
|
33.3%
15/45 • Number of events 18 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Eye disorders
Blurred vision
|
15.6%
7/45 • Number of events 7 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Eye disorders
Dry eye
|
11.1%
5/45 • Number of events 6 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Eye disorders
Watering eyes
|
4.4%
2/45 • Number of events 2 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Eye disorders
Cataract
|
2.2%
1/45 • Number of events 2 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Eye disorders
Floaters
|
2.2%
1/45 • Number of events 1 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Eye disorders
Vitreous hemorrhage
|
2.2%
1/45 • Number of events 1 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
31.1%
14/45 • Number of events 19 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other
|
4.4%
2/45 • Number of events 2 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Renal and urinary disorders
Renal and urinary disorders - Other
|
15.6%
7/45 • Number of events 11 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Renal and urinary disorders
Urinary frequency
|
11.1%
5/45 • Number of events 5 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Renal and urinary disorders
Urinary retention
|
4.4%
2/45 • Number of events 2 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Renal and urinary disorders
Acute kidney injury
|
2.2%
1/45 • Number of events 3 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Renal and urinary disorders
Bladder spasm
|
2.2%
1/45 • Number of events 1 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Renal and urinary disorders
Chronic kidney disease
|
2.2%
1/45 • Number of events 1 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Renal and urinary disorders
Hematuria
|
2.2%
1/45 • Number of events 1 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Renal and urinary disorders
Renal calculi
|
2.2%
1/45 • Number of events 2 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Renal and urinary disorders
Urinary incontinence
|
2.2%
1/45 • Number of events 3 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Renal and urinary disorders
Urinary tract pain
|
2.2%
1/45 • Number of events 1 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Renal and urinary disorders
Urine discoloration
|
2.2%
1/45 • Number of events 1 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Surgical and medical procedures
Surgical and medical procedures - Other
|
33.3%
15/45 • Number of events 26 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Cardiac disorders
Cardiac disorders - Other
|
17.8%
8/45 • Number of events 11 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Cardiac disorders
Sinus bradycardia
|
6.7%
3/45 • Number of events 6 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Cardiac disorders
Sinus tachycardia
|
6.7%
3/45 • Number of events 4 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Cardiac disorders
Cardiac arrest
|
2.2%
1/45 • Number of events 1 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Cardiac disorders
Chest pain - cardiac
|
2.2%
1/45 • Number of events 1 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Injury, poisoning and procedural complications
Bruising
|
13.3%
6/45 • Number of events 7 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other
|
6.7%
3/45 • Number of events 6 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Injury, poisoning and procedural complications
Fall
|
2.2%
1/45 • Number of events 1 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Ear and labyrinth disorders
Tinnitus
|
4.4%
2/45 • Number of events 2 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other
|
2.2%
1/45 • Number of events 1 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Ear and labyrinth disorders
Ear pain
|
2.2%
1/45 • Number of events 2 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Ear and labyrinth disorders
Vertigo
|
2.2%
1/45 • Number of events 1 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other
|
4.4%
2/45 • Number of events 2 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Reproductive system and breast disorders
Pelvic pain
|
2.2%
1/45 • Number of events 1 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Reproductive system and breast disorders
Perineal pain
|
2.2%
1/45 • Number of events 1 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
2.2%
1/45 • Number of events 1 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
|
Immune system disorders
Allergic reaction
|
8.9%
4/45 • Number of events 7 • Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place