Trial Outcomes & Findings for Acalabrutinib-Lenalidomide-Rituximab in Patients With Untreated MCL (NCT NCT03863184)
NCT ID: NCT03863184
Last Updated: 2026-04-28
Results Overview
Percentage of subjects with MRD-negative CR at the conclusion of 12 cycles of induction therapy. Each cycle is 28 days, 12 cycles is approximately 1 year.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
37 participants
Primary outcome timeframe
1 year
Results posted on
2026-04-28
Participant Flow
A total of 37 patients were consented and 34 were enrolled, with 3 patient deemed as screen failure.
Participant milestones
| Measure |
ALR -Cohort A
Patients in Cohort A-ALR will receive combination therapy of acalabrutinib, lenalidomide, and rituximab.
|
Cohort B-ALO
Subjects in ALO cohort will get a combination of acalabrutinib, lenalidomide and obinutuzumab
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
10
|
|
Overall Study
COMPLETED
|
24
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Acalabrutinib-Lenalidomide-Rituximab in Patients With Untreated MCL
Baseline characteristics by cohort
| Measure |
ALR in Combination
n=24 Participants
Acalabrutinib, lenalidomide, and rituximab in combination
Acalabrutinib: Acalabrutinib, oral, 100 mg BID, continuous
Lenalidomide: Lenalidomide, 15 mg for cycle 1, then escalated as tolerated to 20 mg, QD, Days 1-21 out of 28 day cycles
Rituximab: Rituximab, IV, weekly during Cycle 1, and every other cycle starting with Cycle 4
|
ALO in Combination
n=10 Participants
Acalabrutinib, Lenalidomide and Obinutuzumab in combination
Acalabrutinib 100 mg BID continuous
Lenalidomide on days 1-21 (15 mg for cycle 1, then escalate as tolerated to 20 mg)
Obinutuzumab on days 1, 8, 15 of cycle 1, day 1 of cycles 2-6, then every 2 cycles
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64 Years
n=9 Participants
|
65 Years
n=24 Participants
|
65 Years
n=23 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=9 Participants
|
2 Participants
n=24 Participants
|
7 Participants
n=23 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=9 Participants
|
8 Participants
n=24 Participants
|
27 Participants
n=23 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=9 Participants
|
0 Participants
n=24 Participants
|
3 Participants
n=23 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=9 Participants
|
9 Participants
n=24 Participants
|
30 Participants
n=23 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=23 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=23 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=9 Participants
|
8 Participants
n=24 Participants
|
30 Participants
n=23 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=9 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=23 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: MRD \< 10-6 after 12 cycle induction
Percentage of subjects with MRD-negative CR at the conclusion of 12 cycles of induction therapy. Each cycle is 28 days, 12 cycles is approximately 1 year.
Outcome measures
| Measure |
ALR in Combination
n=24 Participants
Acalabrutinib, lenalidomide, and rituximab in combination
Acalabrutinib: Acalabrutinib, oral, 100 mg BID, continuous
Lenalidomide: Lenalidomide, 15 mg for cycle 1, then escalated as tolerated to 20 mg, QD, Days 1-21 out of 28 day cycles
Rituximab: Rituximab, IV, weekly during Cycle 1, and every other cycle starting with Cycle 4
|
ALO in Combination
n=10 Participants
Acalabrutinib, Lenalidomide and Obinutuzumab in combination
Acalabrutinib 100 mg BID continuous
Lenalidomide on days 1-21 (15 mg for cycle 1, then escalate as tolerated to 20 mg)
Obinutuzumab on days 1, 8, 15 of cycle 1, day 1 of cycles 2-6, then every 2 cycles
|
|---|---|---|
|
Peripheral Blood Minimum Residual Disease (MRD)-Negative Complete Response (CR) Rate of the Combination of Acalabrutinib + Lenalidomide + Rituximab at the Conclusion of 12 Cycles of Induction Therapy
|
16 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 4 yearsRate of subjects that experience 1 or more adverse events
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 yearsRate of subjects who achieve a partial or complete response
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 yearsRate of subjects who achieve a complete response
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 yearsMeasured from start of treatment to time of progression or death from any cause, measured in months
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 yearsMeasured from start of treatment to death from any cause, measured in months
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 yearsMeasured from end of study treatment to initiation of next lymphoma treatment, measured in months
Outcome measures
Outcome data not reported
Adverse Events
ALR -Cohort A
Serious events: 16 serious events
Other events: 24 other events
Deaths: 1 deaths
Cohort B-ALO
Serious events: 4 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ALR -Cohort A
n=24 participants at risk
Patients in Cohort A-ALR will receive combination therapy of acalabrutinib, lenalidomide, and rituximab.
|
Cohort B-ALO
n=10 participants at risk
Subjects in ALO cohort will get a combination of acalabrutinib, lenalidomide and obinutuzumab
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Shingles
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
General disorders
Fever
|
12.5%
3/24 • Number of events 7 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
10.0%
1/10 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Infections and infestations
Lung Infection
|
8.3%
2/24 • Number of events 2 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Infections and infestations
COVID-19 Infection
|
16.7%
4/24 • Number of events 5 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Metabolism and nutrition disorders
Lenalidomide Overdose
|
4.2%
1/24 • Number of events 2 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Musculoskeletal and connective tissue disorders
Shoulder Pain
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma
|
16.7%
4/24 • Number of events 5 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
8.3%
2/24 • Number of events 2 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
10.0%
1/10 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanoma
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
10.0%
1/10 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Cell Carcinoma
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Actinic Keratosis
|
8.3%
2/24 • Number of events 2 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Nervous system disorders
Transverse Myelitis
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Nervous system disorders
Intracranial Hemorrhage
|
0.00%
0/24 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
10.0%
1/10 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Psychiatric disorders
Confusion
|
8.3%
2/24 • Number of events 2 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
8.3%
2/24 • Number of events 2 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
COVID-related Pneumonia
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
Other adverse events
| Measure |
ALR -Cohort A
n=24 participants at risk
Patients in Cohort A-ALR will receive combination therapy of acalabrutinib, lenalidomide, and rituximab.
|
Cohort B-ALO
n=10 participants at risk
Subjects in ALO cohort will get a combination of acalabrutinib, lenalidomide and obinutuzumab
|
|---|---|---|
|
Investigations
Platelet count decreased
|
29.2%
7/24 • Number of events 8 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
50.0%
5/10 • Number of events 9 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Cardiac disorders
Chest pain - cardiac
|
8.3%
2/24 • Number of events 2 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Cardiac disorders
Palpitations
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
10.0%
1/10 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Cardiac disorders
Sinus bradycardia
|
8.3%
2/24 • Number of events 2 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
20.0%
2/10 • Number of events 3 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Cardiac disorders
Ventricular arrhythmia
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
8/24 • Number of events 13 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
30.0%
3/10 • Number of events 12 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Blood and lymphatic system disorders
Hemoptysis
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Investigations
Neutrophil count decreased
|
70.8%
17/24 • Number of events 28 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
80.0%
8/10 • Number of events 24 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Hepatobiliary disorders
Gallstones
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Hepatobiliary disorders
Cholecystitis
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
10.0%
1/10 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Injury, poisoning and procedural complications
Bruising
|
20.8%
5/24 • Number of events 7 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
40.0%
4/10 • Number of events 5 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Injury, poisoning and procedural complications
Fall
|
8.3%
2/24 • Number of events 2 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
20.0%
2/10 • Number of events 2 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Injury, poisoning and procedural complications
Fracture
|
8.3%
2/24 • Number of events 2 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Vascular disorders
Lymphedema
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/24 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
10.0%
1/10 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Vascular disorders
Pulmonary embolism
|
8.3%
2/24 • Number of events 2 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Vascular disorders
Thromboembolic event
|
12.5%
3/24 • Number of events 3 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Psychiatric disorders
Confusion
|
8.3%
2/24 • Number of events 2 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Psychiatric disorders
Depression
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
10.0%
1/10 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Psychiatric disorders
Insomnia
|
16.7%
4/24 • Number of events 4 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
20.0%
2/10 • Number of events 3 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Vascular disorders
Atherosclerosis
|
0.00%
0/24 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
10.0%
1/10 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Vascular disorders
Coronary Artery Calcification
|
0.00%
0/24 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
10.0%
1/10 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Vascular disorders
Flushing
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Vascular disorders
Hypertension
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
30.0%
3/10 • Number of events 7 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Vascular disorders
Hypotension
|
12.5%
3/24 • Number of events 4 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Cardiac disorders
Unspecified tachycardia
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Cardiac disorders
Coronary artery disease
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Ear and labyrinth disorders
Ear congestion
|
8.3%
2/24 • Number of events 2 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
10.0%
1/10 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Ear and labyrinth disorders
Ear effusion
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Ear and labyrinth disorders
Ear pain
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
10.0%
1/10 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Ear and labyrinth disorders
Hearing impaired
|
12.5%
3/24 • Number of events 3 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
10.0%
1/10 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Ear and labyrinth disorders
Hemotypmanum
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Ear and labyrinth disorders
Ear perforation
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Ear and labyrinth disorders
Tinnitus
|
8.3%
2/24 • Number of events 2 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Ear and labyrinth disorders
Vertigo
|
4.2%
1/24 • Number of events 2 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
10.0%
1/10 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Endocrine disorders
Euthyroid Sick Syndrome
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Endocrine disorders
Hyperthyroidism
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Endocrine disorders
Hyerparathyroidism
|
0.00%
0/24 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
10.0%
1/10 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Reproductive system and breast disorders
Libido decreased
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Renal and urinary disorders
Difficult urinating
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
10.0%
1/10 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Renal and urinary disorders
Dysuria
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
10.0%
1/10 • Number of events 2 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Renal and urinary disorders
Hematuria
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
10.0%
1/10 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Renal and urinary disorders
Kidney stones
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Renal and urinary disorders
Proteinuria
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Renal and urinary disorders
Renal pain
|
0.00%
0/24 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
10.0%
1/10 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Renal and urinary disorders
Urinary frequency
|
20.8%
5/24 • Number of events 6 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Renal and urinary disorders
Urinary incontinence
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Renal and urinary disorders
Urinary tract pain
|
4.2%
1/24 • Number of events 2 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Renal and urinary disorders
Urinary urgency
|
0.00%
0/24 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
10.0%
1/10 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Renal and urinary disorders
Urine discoloration
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Surgical and medical procedures
Cardiac catheterization
|
0.00%
0/24 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
10.0%
1/10 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Surgical and medical procedures
Carpal tunnel procedure
|
4.2%
1/24 • Number of events 2 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Surgical and medical procedures
Cataract surgery
|
4.2%
1/24 • Number of events 2 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Surgical and medical procedures
Skin lesion removal
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Surgical and medical procedures
Skim removal procedure
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Surgical and medical procedures
Dental Procedure, Unspecified
|
12.5%
3/24 • Number of events 3 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Surgical and medical procedures
Eye sugery
|
4.2%
1/24 • Number of events 2 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Surgical and medical procedures
Inguinal hernia repair
|
0.00%
0/24 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
10.0%
1/10 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Surgical and medical procedures
Laser lithotripsy
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Surgical and medical procedures
Moh's procedure
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Surgical and medical procedures
Mole removal
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Surgical and medical procedures
Root canal
|
12.5%
3/24 • Number of events 3 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Surgical and medical procedures
Scalp cyst removal
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Reproductive system and breast disorders
Pelvic Pain
|
0.00%
0/24 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
10.0%
1/10 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Reproductive system and breast disorders
Pelvic floor muscle weakness
|
0.00%
0/24 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
10.0%
1/10 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Renal and urinary disorders
Acute kidney injury
|
16.7%
4/24 • Number of events 4 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Renal and urinary disorders
Creatinine clearance decreased
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Nervous system disorders
Dizziness
|
25.0%
6/24 • Number of events 7 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
30.0%
3/10 • Number of events 4 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Nervous system disorders
Dysgeusia
|
12.5%
3/24 • Number of events 3 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
20.0%
2/10 • Number of events 2 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Surgical and medical procedures
Tooth extraction
|
12.5%
3/24 • Number of events 3 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Surgical and medical procedures
Umbilical hernia repair
|
0.00%
0/24 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
10.0%
1/10 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Nervous system disorders
Cognitive disturbance
|
0.00%
0/24 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
10.0%
1/10 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Nervous system disorders
Concentration impairment
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Nervous system disorders
Headache
|
62.5%
15/24 • Number of events 17 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
90.0%
9/10 • Number of events 12 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Nervous system disorders
Hermitte's Syndrome
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Nervous system disorders
Memory impairment
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
10.0%
1/10 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Nervous system disorders
Neuralgia
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
10.0%
1/10 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Nervous system disorders
Paresthesia
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
20.0%
2/10 • Number of events 3 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Nervous system disorders
Peripheral neuropathy
|
25.0%
6/24 • Number of events 6 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Nervous system disorders
Presyncope
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Nervous system disorders
Spacsticity
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Nervous system disorders
Subdural hematoma
|
0.00%
0/24 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
10.0%
1/10 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Nervous system disorders
Subdural hygroma
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Nervous system disorders
Syncope
|
12.5%
3/24 • Number of events 3 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Nervous system disorders
Weakness
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Metabolism and nutrition disorders
Anorexia
|
8.3%
2/24 • Number of events 2 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
20.0%
2/10 • Number of events 2 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Metabolism and nutrition disorders
Dehydration
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
10.0%
1/10 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
12.5%
3/24 • Number of events 4 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
30.0%
3/10 • Number of events 5 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/24 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
10.0%
1/10 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
0.00%
0/24 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
10.0%
1/10 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
16.7%
4/24 • Number of events 5 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
10.0%
1/10 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
8.3%
2/24 • Number of events 2 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
12.5%
3/24 • Number of events 3 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/24 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
10.0%
1/10 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
4.2%
1/24 • Number of events 2 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
20.0%
2/10 • Number of events 2 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Metabolism and nutrition disorders
Vitamin D Deficiency
|
0.00%
0/24 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
10.0%
1/10 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Eye disorders
Blurred vision
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
10.0%
1/10 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Eye disorders
Dry eye
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
10.0%
1/10 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Eye disorders
Eye discharge
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Eye disorders
Eye strain
|
0.00%
0/24 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
10.0%
1/10 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Eye disorders
Stye
|
4.2%
1/24 • Number of events 2 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Eye disorders
Vision decreased
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Eye disorders
Vision disturbance
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Eye disorders
Watering eyes
|
0.00%
0/24 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
20.0%
2/10 • Number of events 2 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
General disorders
Alopecia
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
General disorders
Chills
|
16.7%
4/24 • Number of events 4 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
40.0%
4/10 • Number of events 4 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
General disorders
Diaphoresis
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
General disorders
Edema face
|
4.2%
1/24 • Number of events 3 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
General disorders
Edema limbs
|
20.8%
5/24 • Number of events 6 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
General disorders
Irritability
|
8.3%
2/24 • Number of events 2 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
General disorders
Localized edema
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
10.0%
1/10 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
General disorders
Lymphadenopathy
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
General disorders
Night sweats
|
12.5%
3/24 • Number of events 3 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/24 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
30.0%
3/10 • Number of events 3 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
General disorders
General pain
|
0.00%
0/24 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
30.0%
3/10 • Number of events 6 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
General disorders
Pedal Edema
|
0.00%
0/24 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
10.0%
1/10 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Gastrointestinal disorders
Burning sensation of tongue
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Gastrointestinal disorders
Constipation
|
45.8%
11/24 • Number of events 14 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
40.0%
4/10 • Number of events 7 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Gastrointestinal disorders
Diarrhea
|
70.8%
17/24 • Number of events 29 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
90.0%
9/10 • Number of events 25 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Gastrointestinal disorders
Dry mouth
|
8.3%
2/24 • Number of events 2 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Gastrointestinal disorders
Dyspepsia
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Gastrointestinal disorders
Epigastric pain
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
10.0%
1/10 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Gastrointestinal disorders
Flatulence
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
20.0%
2/10 • Number of events 2 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Gastrointestinal disorders
Gastritis
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
10.0%
1/10 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Gastrointestinal disorders
Gastroenteritis
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Investigations
Weight loss
|
16.7%
4/24 • Number of events 4 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
30.0%
3/10 • Number of events 3 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Investigations
Transaminitis
|
12.5%
3/24 • Number of events 3 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
10.0%
1/10 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Investigations
Lymphocyte count increased
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
10.0%
1/10 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Investigations
Lymphocyte count decreased
|
29.2%
7/24 • Number of events 9 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
20.0%
2/10 • Number of events 2 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Investigations
Lipase increased
|
0.00%
0/24 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
10.0%
1/10 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Investigations
LDH increased
|
0.00%
0/24 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
10.0%
1/10 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Investigations
Alanine aminotransferase increased
|
12.5%
3/24 • Number of events 6 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
40.0%
4/10 • Number of events 7 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Infections and infestations
Viral hepatitis
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Infections and infestations
E.coli infection
|
0.00%
0/24 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
20.0%
2/10 • Number of events 2 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Infections and infestations
C. difficile colitis
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Infections and infestations
Bronchial infection
|
4.2%
1/24 • Number of events 2 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Infections and infestations
H. pylori infection
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Infections and infestations
Eye infection
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Skin and subcutaneous tissue disorders
Acral nevus
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
4.2%
1/24 • Number of events 2 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
0.00%
0/24 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
10.0%
1/10 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
29.2%
7/24 • Number of events 9 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
50.0%
5/10 • Number of events 7 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
General disorders
Fatigue
|
75.0%
18/24 • Number of events 25 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
50.0%
5/10 • Number of events 7 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
General disorders
Fever
|
33.3%
8/24 • Number of events 9 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
40.0%
4/10 • Number of events 5 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
General disorders
Flu-like symptoms
|
8.3%
2/24 • Number of events 2 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
10.0%
1/10 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
General disorders
Gait disturbance
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
10.0%
1/10 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
General disorders
Hair thinning
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
General disorders
Infusion related reaction
|
45.8%
11/24 • Number of events 12 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
10.0%
1/10 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
30.0%
3/10 • Number of events 4 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
54.2%
13/24 • Number of events 21 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
50.0%
5/10 • Number of events 9 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
41.7%
10/24 • Number of events 17 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
20.0%
2/10 • Number of events 2 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.3%
2/24 • Number of events 2 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
8.3%
2/24 • Number of events 2 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
40.0%
4/10 • Number of events 5 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
12.5%
3/24 • Number of events 3 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
41.7%
10/24 • Number of events 10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
60.0%
6/10 • Number of events 7 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum perforation
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Chest tightness
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
16.7%
4/24 • Number of events 5 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
20.0%
2/10 • Number of events 2 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary nodule
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Recurrent organizing pneumonia
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
12.5%
3/24 • Number of events 4 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
10.0%
1/10 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
8.3%
2/24 • Number of events 2 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
8.3%
2/24 • Number of events 2 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
0.00%
0/24 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
10.0%
1/10 • Number of events 3 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
25.0%
6/24 • Number of events 6 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
40.0%
4/10 • Number of events 4 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Gastrointestinal disorders
Abdominal cramps
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Gastrointestinal disorders
Abdominal distension
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
10.0%
1/10 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Gastrointestinal disorders
Abdominal pain
|
29.2%
7/24 • Number of events 11 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
30.0%
3/10 • Number of events 3 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Gastrointestinal disorders
Anal spasm
|
0.00%
0/24 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
10.0%
1/10 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Gastrointestinal disorders
Bloating
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
12.5%
3/24 • Number of events 3 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
10.0%
1/10 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Gastrointestinal disorders
Hematochezia
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Gastrointestinal disorders
Hemorrhoids
|
12.5%
3/24 • Number of events 3 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
10.0%
1/10 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Gastrointestinal disorders
Increased appetite
|
0.00%
0/24 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
10.0%
1/10 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Gastrointestinal disorders
Nausea
|
37.5%
9/24 • Number of events 14 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
70.0%
7/10 • Number of events 12 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Gastrointestinal disorders
Oral pain
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Gastrointestinal disorders
Oral thrush
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Gastrointestinal disorders
Pancreatitis
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/24 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
10.0%
1/10 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Gastrointestinal disorders
Rectal pain
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
10.0%
1/10 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Gastrointestinal disorders
Tubular adenoma
|
0.00%
0/24 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
10.0%
1/10 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Gastrointestinal disorders
Vomiting
|
4.2%
1/24 • Number of events 2 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
30.0%
3/10 • Number of events 6 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Investigations
Weight gain
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Gastrointestinal disorders
Aspartate aminotransferase increased
|
12.5%
3/24 • Number of events 4 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
40.0%
4/10 • Number of events 9 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/24 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
30.0%
3/10 • Number of events 10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Investigations
Blood bilirubin increased
|
4.2%
1/24 • Number of events 7 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
40.0%
4/10 • Number of events 5 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Investigations
Creatinine increased
|
16.7%
4/24 • Number of events 4 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
30.0%
3/10 • Number of events 5 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Investigations
INR increased
|
0.00%
0/24 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
10.0%
1/10 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/24 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
10.0%
1/10 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Investigations
TSH Elevated
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Investigations
White blood cell count decreased
|
33.3%
8/24 • Number of events 10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
40.0%
4/10 • Number of events 19 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.0%
6/24 • Number of events 8 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
8.3%
2/24 • Number of events 2 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
10.0%
1/10 • Number of events 2 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
6/24 • Number of events 13 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
30.0%
3/10 • Number of events 6 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
20.0%
2/10 • Number of events 4 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
10.0%
1/10 • Number of events 2 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
20.0%
2/10 • Number of events 4 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Musculoskeletal and connective tissue disorders
Muscle cramping
|
16.7%
4/24 • Number of events 5 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
50.0%
5/10 • Number of events 5 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
4.2%
1/24 • Number of events 2 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.3%
8/24 • Number of events 8 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
20.0%
2/10 • Number of events 4 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Musculoskeletal and connective tissue disorders
Non-cardiac chest pain
|
8.3%
2/24 • Number of events 2 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
54.2%
13/24 • Number of events 25 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
20.0%
2/10 • Number of events 2 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
8.3%
2/24 • Number of events 2 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
10.0%
1/10 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Musculoskeletal and connective tissue disorders
Submandibular tenderness
|
0.00%
0/24 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
10.0%
1/10 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Musculoskeletal and connective tissue disorders
Trochanteric bursitis
|
0.00%
0/24 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
10.0%
1/10 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Infections and infestations
COVID-19 Infection
|
75.0%
18/24 • Number of events 28 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
30.0%
3/10 • Number of events 3 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Infections and infestations
Yeast infection
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Infections and infestations
Urinary tract infection
|
8.3%
2/24 • Number of events 6 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Infections and infestations
Upper respiratory infection
|
16.7%
4/24 • Number of events 6 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
40.0%
4/10 • Number of events 7 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Infections and infestations
Shingles
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
10.0%
1/10 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Infections and infestations
Skin Infection
|
8.3%
2/24 • Number of events 3 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Infections and infestations
Conjunctivitis
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Infections and infestations
Sinusitis
|
12.5%
3/24 • Number of events 3 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
10.0%
1/10 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Infections and infestations
Tooth infection
|
12.5%
3/24 • Number of events 4 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
10.0%
1/10 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Infections and infestations
Infective rhinitis
|
4.2%
1/24 • Number of events 2 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Infections and infestations
Otitis externa
|
8.3%
2/24 • Number of events 2 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
10.0%
1/10 • Number of events 3 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Infections and infestations
Herpes infection
|
4.2%
1/24 • Number of events 2 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Injury, poisoning and procedural complications
Head contusion
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
10.0%
1/10 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Skin and subcutaneous tissue disorders
Abrasions
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Skin and subcutaneous tissue disorders
Brittle nails
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
20.8%
5/24 • Number of events 5 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
30.0%
3/10 • Number of events 3 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Skin and subcutaneous tissue disorders
Erythroderma
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Skin and subcutaneous tissue disorders
Granuloma annulare
|
0.00%
0/24 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
10.0%
1/10 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
8.3%
2/24 • Number of events 2 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
10.0%
1/10 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Skin and subcutaneous tissue disorders
Ingrown hair
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Skin and subcutaneous tissue disorders
Lipoma
|
8.3%
2/24 • Number of events 3 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Skin and subcutaneous tissue disorders
Molluscum - Right Forearm
|
0.00%
0/24 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
10.0%
1/10 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
12.5%
3/24 • Number of events 3 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
10.0%
1/10 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
87.5%
21/24 • Number of events 43 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
60.0%
6/10 • Number of events 11 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
8.3%
2/24 • Number of events 2 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
10.0%
1/10 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Skin and subcutaneous tissue disorders
Scalp rash
|
4.2%
1/24 • Number of events 2 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Skin and subcutaneous tissue disorders
Seborrheic Dermatitis
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Skin and subcutaneous tissue disorders
Seborrheic Keratitis
|
0.00%
0/24 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
10.0%
1/10 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Skin and subcutaneous tissue disorders
Skin Lesion
|
29.2%
7/24 • Number of events 7 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
10.0%
1/10 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
8.3%
2/24 • Number of events 3 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Skin and subcutaneous tissue disorders
Arcochordons
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Skin and subcutaneous tissue disorders
Ear blister
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign cyst
|
8.3%
2/24 • Number of events 2 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid nodule
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung nodule
|
12.5%
3/24 • Number of events 3 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Precancerous skin scaling
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Stomach lesion
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon lesion
|
4.2%
1/24 • Number of events 1 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin nodule
|
8.3%
2/24 • Number of events 2 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
0.00%
0/10 • All AEs will be reported until 30 days after the last dose of study treatment or the start of new anticancer therapy, an average of 2 years.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place