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Trial Outcomes & Findings for Obinutuzumab and Ibrutinib as Front Line Therapy in Treating Patients With Indolent Non-Hodgkin's Lymphomas (NCT NCT03198026)

NCT ID: NCT03198026

Last Updated: 2026-08-18

Results Overview

Response will be assessed by the revised Lugano. Will compute estimates of response, along with corresponding confidence intervals, using appropriate exact methods that take into account the 2-stage design.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

29 participants

Primary outcome timeframe

After 7 cycles of treatment; approximately 7 months

Results posted on

2026-08-18

Participant Flow

Participant milestones

Participant milestones
Measure
Treatment (Ibrutinib, Obinutuzumab)
Patients receive ibrutinib orally (PO) once daily (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive obinutuzumab intravenously (IV) on days 1, 8, and 15 of cycle 1 and day 1 of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Beginning 2 months after cycle 6, patients with stable disease will continue to receive obinutuzumab every 2 months for a total of 12 doses. After completion of study treatment, patients are followed up monthly for 1 year, every 3-6 months for 4 years, and then annually for up to 2 years. Ibrutinib: Given PO Obinutuzumab: Given IV Laboratory Biomarker Analysis: Correlative studies
Overall Study
STARTED
29
Overall Study
COMPLETED
24
Overall Study
NOT COMPLETED
5

Reasons for withdrawal

Reasons for withdrawal
Measure
Treatment (Ibrutinib, Obinutuzumab)
Patients receive ibrutinib orally (PO) once daily (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive obinutuzumab intravenously (IV) on days 1, 8, and 15 of cycle 1 and day 1 of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Beginning 2 months after cycle 6, patients with stable disease will continue to receive obinutuzumab every 2 months for a total of 12 doses. After completion of study treatment, patients are followed up monthly for 1 year, every 3-6 months for 4 years, and then annually for up to 2 years. Ibrutinib: Given PO Obinutuzumab: Given IV Laboratory Biomarker Analysis: Correlative studies
Overall Study
Death
5

Baseline Characteristics

Obinutuzumab and Ibrutinib as Front Line Therapy in Treating Patients With Indolent Non-Hodgkin's Lymphomas

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Treatment (Ibrutinib, Obinutuzumab)
n=29 Participants
Patients receive ibrutinib orally (PO) once daily (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive obinutuzumab intravenously (IV) on days 1, 8, and 15 of cycle 1 and day 1 of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Beginning 2 months after cycle 6, patients with stable disease will continue to receive obinutuzumab every 2 months for a total of 12 doses. After completion of study treatment, patients are followed up monthly for 1 year, every 3-6 months for 4 years, and then annually for up to 2 years. Ibrutinib: Given PO Obinutuzumab: Given IV Laboratory Biomarker Analysis: Correlative studies
Age, Categorical
<=18 years
0 Participants
n=298 Participants
Age, Categorical
Between 18 and 65 years
14 Participants
n=298 Participants
Age, Categorical
>=65 years
15 Participants
n=298 Participants
Sex: Female, Male
Female
14 Participants
n=298 Participants
Sex: Female, Male
Male
15 Participants
n=298 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=298 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
28 Participants
n=298 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants
n=298 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=298 Participants
Race (NIH/OMB)
Asian
2 Participants
n=298 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=298 Participants
Race (NIH/OMB)
Black or African American
3 Participants
n=298 Participants
Race (NIH/OMB)
White
22 Participants
n=298 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=298 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants
n=298 Participants
Region of Enrollment
United States
29 participants
n=298 Participants

PRIMARY outcome

Timeframe: After 7 cycles of treatment; approximately 7 months

Population: There was frequency missing for 1 subject; therefore, the analysis was conducted on 28 subjects.

Response will be assessed by the revised Lugano. Will compute estimates of response, along with corresponding confidence intervals, using appropriate exact methods that take into account the 2-stage design.

Outcome measures

Outcome measures
Measure
Treatment (Ibrutinib, Obinutuzumab)
n=28 Participants
Patients receive ibrutinib orally (PO) once daily (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive obinutuzumab intravenously (IV) on days 1, 8, and 15 of cycle 1 and day 1 of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Beginning 2 months after cycle 6, patients with stable disease will continue to receive obinutuzumab every 2 months for a total of 12 doses. After completion of study treatment, patients are followed up monthly for 1 year, every 3-6 months for 4 years, and then annually for up to 2 years. Ibrutinib: Given PO Obinutuzumab: Given IV Laboratory Biomarker Analysis: Correlative studies
Overall Response Rate in Patients With Newly Diagnosed Indolent Lymphoma Requiring Treatment, Including Complete Response and Partial Response
0.8241 proportion of participants
Interval 0.63 to 0.94

SECONDARY outcome

Timeframe: Two years

Response will be assessed by the revised Lugano. Will compute estimates of response, along with corresponding confidence intervals, using appropriate exact methods that take into account the 2-stage design.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

Estimated using Kaplan-Meier method.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 years

Estimated using Kaplan-Meier method.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 years

Estimated using Kaplan-Meier method.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

Estimated using Kaplan-Meier method.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 years

Estimated using Kaplan-Meier method.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 years

Estimated using Kaplan-Meier method.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Two years

Assessed using Common Terminology Criteria for Adverse Events version 5.0. Will compute estimates toxicity rates, along with corresponding confidence intervals, using appropriate exact methods that take into account the 2-stage design.

Outcome measures

Outcome data not reported

Adverse Events

Treatment (Ibrutinib, Obinutuzumab)

Serious events: 15 serious events
Other events: 21 other events
Deaths: 5 deaths

Serious adverse events

Serious adverse events
Measure
Treatment (Ibrutinib, Obinutuzumab)
n=29 participants at risk
Patients receive ibrutinib orally (PO) once daily (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive obinutuzumab intravenously (IV) on days 1, 8, and 15 of cycle 1 and day 1 of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Beginning 2 months after cycle 6, patients with stable disease will continue to receive obinutuzumab every 2 months for a total of 12 doses. After completion of study treatment, patients are followed up monthly for 1 year, every 3-6 months for 4 years, and then annually for up to 2 years. Ibrutinib: Given PO Obinutuzumab: Given IV Laboratory Biomarker Analysis: Correlative studies
Musculoskeletal and connective tissue disorders
Back pain
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Hepatobiliary disorders
Cholecystitis
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Gastrointestinal disorders
Colitis
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
General disorders
Death
6.9%
2/29 • Number of events 2 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Metabolism and nutrition disorders
Dehydration
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Respiratory, thoracic and mediastinal disorders
Dyspnea
6.9%
2/29 • Number of events 3 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Blood and lymphatic system disorders
Febrile neutropenia
6.9%
2/29 • Number of events 2 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
General disorders
Flu like symptoms
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Gastrointestinal disorders
GI- other (diverticulitis)
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
General disorders
Infusion related reaction
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Infections and infestations
Lung infection
13.8%
4/29 • Number of events 5 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Infections and infestations
Lung infection (COVID-19)
6.9%
2/29 • Number of events 2 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Musculoskeletal and connective tissue disorders
Pain in extremity (right hip pain)
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Gastrointestinal disorders
Pancreatitis
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Cardiac disorders
Pericardial effusion
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic, and mediastinal disorders- other (Paradoxical vocal cord dysfunction)
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Infections and infestations
Sepsis
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Social circumstances
Social circumstances- other (Death)
6.9%
2/29 • Number of events 2 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Nervous system disorders
Stroke
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Infections and infestations
Upper respiratory infection
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Renal and urinary disorders
Urinary tract obstruction
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.

Other adverse events

Other adverse events
Measure
Treatment (Ibrutinib, Obinutuzumab)
n=29 participants at risk
Patients receive ibrutinib orally (PO) once daily (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive obinutuzumab intravenously (IV) on days 1, 8, and 15 of cycle 1 and day 1 of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Beginning 2 months after cycle 6, patients with stable disease will continue to receive obinutuzumab every 2 months for a total of 12 doses. After completion of study treatment, patients are followed up monthly for 1 year, every 3-6 months for 4 years, and then annually for up to 2 years. Ibrutinib: Given PO Obinutuzumab: Given IV Laboratory Biomarker Analysis: Correlative studies
Psychiatric disorders
Delusions
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Psychiatric disorders
Depression
13.8%
4/29 • Number of events 4 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Gastrointestinal disorders
Diarrhea
55.2%
16/29 • Number of events 24 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Nervous system disorders
Dizziness
37.9%
11/29 • Number of events 16 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Eye disorders
Dry eyes
6.9%
2/29 • Number of events 2 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Gastrointestinal disorders
Dry mouth
10.3%
3/29 • Number of events 3 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Skin and subcutaneous tissue disorders
Dry skin
27.6%
8/29 • Number of events 11 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Nervous system disorders
Dysesthesia
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Nervous system disorders
Dysgeusia
10.3%
3/29 • Number of events 3 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Gastrointestinal disorders
Dyspepsia
24.1%
7/29 • Number of events 7 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Gastrointestinal disorders
Dysphagia
13.8%
4/29 • Number of events 4 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Respiratory, thoracic and mediastinal disorders
Dyspnea
20.7%
6/29 • Number of events 12 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Ear and labyrinth disorders
Ear and labyrinth disorders- other (Feeling of fullness in ears)
6.9%
2/29 • Number of events 3 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Ear and labyrinth disorders
Ear and labyrinth disorders- other (right ear feels clogged)
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Ear and labyrinth disorders
Ear and labyrinth disorders- other (whistling in ears)
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Ear and labyrinth disorders
Ear pain
6.9%
2/29 • Number of events 2 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
General disorders
Edema face
6.9%
2/29 • Number of events 2 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
General disorders
Edema- limb
44.8%
13/29 • Number of events 22 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Nervous system disorders
Encephalopathy
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Respiratory, thoracic and mediastinal disorders
Epistaxis
34.5%
10/29 • Number of events 13 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Reproductive system and breast disorders
Erectile dysfunction
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Eye disorders
Eye disorders
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Eye disorders
Eye disorders- other (difficulty focusing eyes)
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Eye disorders
Eye disorders- other (Macular degeneration)
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Eye disorders
Eye disorders- other (Occasional blurred vision, white discharge)
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Eye disorders
Eye disorders- other (Stye/ horleolum)
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Injury, poisoning and procedural complications
Fall
20.7%
6/29 • Number of events 9 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
General disorders
Fatigue
37.9%
11/29 • Number of events 19 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Gastrointestinal disorders
Fecal incontinence
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
General disorders
Fever
24.1%
7/29 • Number of events 9 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Skin and subcutaneous tissue disorders
Fingernail loss
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Skin and subcutaneous tissue disorders
Fingernail ridging
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Musculoskeletal and connective tissue disorders
Flank pain
13.8%
4/29 • Number of events 5 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Eye disorders
Floaters
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
General disorders
Flu like symptoms
13.8%
4/29 • Number of events 6 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Vascular disorders
Flushing
3.4%
1/29 • Number of events 3 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Gastrointestinal disorders
Gastritis
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Gastrointestinal disorders
Gastroesophageal reflux disease
20.7%
6/29 • Number of events 7 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Gastrointestinal disorders
Gastrointestinal disorders- other (cracked tooth)
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Gastrointestinal disorders
Gastrointestinal disorders- other (hypersalivation)
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
General disorders
General disorders and administration site conditions- other
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
General disorders
General disorders and administrative site disorders- other (cold intolerance)
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
General disorders
Generalized edema
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
10.3%
3/29 • Number of events 3 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Reproductive system and breast disorders
Genital edema
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Gastrointestinal disorders
GI disorders- other (Occasional gum burning)
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Gastrointestinal disorders
GI- other (blood in stool, occasional)
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Gastrointestinal disorders
GI- other (diverticulitis)
3.4%
1/29 • Number of events 2 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Gastrointestinal disorders
GI- other (IBS)
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Eye disorders
Glaucoma
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Nervous system disorders
Headache
37.9%
11/29 • Number of events 18 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Ear and labyrinth disorders
Hearing impairement
13.8%
4/29 • Number of events 4 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Vascular disorders
Hematoma
10.3%
3/29 • Number of events 5 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Renal and urinary disorders
Hematuria
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Infections and infestations
Herpes simplex reactivation
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Respiratory, thoracic and mediastinal disorders
Hiccups
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Respiratory, thoracic and mediastinal disorders
Hoarseness
10.3%
3/29 • Number of events 3 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Vascular disorders
Hot flashes
10.3%
3/29 • Number of events 3 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Metabolism and nutrition disorders
Hypercalcemia
6.9%
2/29 • Number of events 2 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Metabolism and nutrition disorders
Hyperglycemia
27.6%
8/29 • Number of events 12 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Skin and subcutaneous tissue disorders
Hyperhidrosis
27.6%
8/29 • Number of events 8 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Metabolism and nutrition disorders
Hyperkalemia
10.3%
3/29 • Number of events 7 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Investigations
Hyperlipidemia
3.4%
1/29 • Number of events 2 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Metabolism and nutrition disorders
Hypernatremia
6.9%
2/29 • Number of events 2 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Vascular disorders
Hypertension
24.1%
7/29 • Number of events 9 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Metabolism and nutrition disorders
Hyperuricemia
24.1%
7/29 • Number of events 8 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Metabolism and nutrition disorders
Hypoalbuminemia
3.4%
1/29 • Number of events 6 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Metabolism and nutrition disorders
Hypocalcemia
17.2%
5/29 • Number of events 11 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Metabolism and nutrition disorders
Hypoglycemia
6.9%
2/29 • Number of events 2 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Metabolism and nutrition disorders
Hypokalemia
13.8%
4/29 • Number of events 4 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Metabolism and nutrition disorders
Hypomagnesemia
17.2%
5/29 • Number of events 9 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Metabolism and nutrition disorders
Hyponatremia
10.3%
3/29 • Number of events 4 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Metabolism and nutrition disorders
Hypophosphatemia
6.9%
2/29 • Number of events 2 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Respiratory, thoracic and mediastinal disorders
Hypoxia
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Immune system disorders
Immune system disorders- other (hypogammaglobulinemia)
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Infections and infestations
Infection and infestations- other
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Infections and infestations
Infections and infestations- other (COVID-19)
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Infections and infestations
Infections and infestations- other (Ear infection)
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Infections and infestations
Infections and infestations- other (eye rash)
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Infections and infestations
Infections and infestations- other (Food poisoning)
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Infections and infestations
Infections and infestations- other (oral yeast infection)
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Infections and infestations
Infections and infestations- other (Thrush)
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Infections and infestations
Infections and infestations- other (Viral infection)
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
General disorders
Infusion related reaction
51.7%
15/29 • Number of events 23 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Injury, poisoning and procedural complications
Injury, poisoning, and procedural complications- other
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Psychiatric disorders
Insomnia
20.7%
6/29 • Number of events 7 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Metabolism and nutrition disorders
Iron deficiency
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Psychiatric disorders
Libido decreased
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Psychiatric disorders
Lipase increased
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
General disorders
Localized edema
6.9%
2/29 • Number of events 2 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Infections and infestations
Lung infection
17.2%
5/29 • Number of events 7 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Infections and infestations
Lung infection (COVID-19)
20.7%
6/29 • Number of events 7 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Investigations
Lymphocyte count decreased
10.3%
3/29 • Number of events 6 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Nervous system disorders
Memory impairment
10.3%
3/29 • Number of events 3 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Nervous system disorders
Memory problems
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Reproductive system and breast disorders
Menorrhagia
3.4%
1/29 • Number of events 2 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Metabolism and nutrition disorders
Metabolism and nutrition disorders- other (iron deficiency)
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Nervous system disorders
Movement involuntary
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Gastrointestinal disorders
Mucositis oral
31.0%
9/29 • Number of events 11 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Musculoskeletal and connective tissue disorders
Muscle cramp
24.1%
7/29 • Number of events 10 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
3.4%
1/29 • Number of events 2 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders- other (Pain after fall, Left knee, torn meniscus)
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Vascular disorders
Thromboembolic event
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders- other (Partial hamstring tear)
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders- other (sprained right peroneal tendon)
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Musculoskeletal and connective tissue disorders
Muskuloskeletal and connective tissue- other (ankle strain)
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Musculoskeletal and connective tissue disorders
Muskuloskeletal and connective tissue- other (sprained ankle, right)
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Musculoskeletal and connective tissue disorders
Myalgia
48.3%
14/29 • Number of events 33 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Skin and subcutaneous tissue disorders
Nail changes
6.9%
2/29 • Number of events 3 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Skin and subcutaneous tissue disorders
Nail ridging
6.9%
2/29 • Number of events 2 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Respiratory, thoracic and mediastinal disorders
Nasal congestion
37.9%
11/29 • Number of events 13 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Gastrointestinal disorders
Nausea
58.6%
17/29 • Number of events 25 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Musculoskeletal and connective tissue disorders
Neck pain
6.9%
2/29 • Number of events 2 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified- other (Subpleural lung nodule)
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant, and unspecified- other (Squamous cell carcinoma on leg)
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant, and unspecified- other (pulmonary adenocarcinoma)
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant, and unspecified- other (squamous cell cacinoma)
6.9%
2/29 • Number of events 2 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms, benign, malignant and unspecified- other
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Nervous system disorders
Neuralgia
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Investigations
Neutrophil count decreased
31.0%
9/29 • Number of events 17 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
General disorders
Non-cardiac chest pain
13.8%
4/29 • Number of events 5 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Gastrointestinal disorders
Oral hemorrhage
3.4%
1/29 • Number of events 2 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Gastrointestinal disorders
Oral pain
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Musculoskeletal and connective tissue disorders
Osteoporosis
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Musculoskeletal and connective tissue disorders
Pain in extremity
20.7%
6/29 • Number of events 8 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Skin and subcutaneous tissue disorders
Pain of skin
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Cardiac disorders
Palpitations
10.3%
3/29 • Number of events 4 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Gastrointestinal disorders
Pancreatitis
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Nervous system disorders
Paresthesia
6.9%
2/29 • Number of events 4 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Infections and infestations
Paronychia
6.9%
2/29 • Number of events 4 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Reproductive system and breast disorders
Pelvic pain
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Cardiac disorders
Pericardial effusion
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Investigations
Platelet count decreased
37.9%
11/29 • Number of events 23 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Respiratory, thoracic and mediastinal disorders
Pleural effsuion
6.9%
2/29 • Number of events 2 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Respiratory, thoracic and mediastinal disorders
Postnasal drip
6.9%
2/29 • Number of events 2 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Respiratory, thoracic and mediastinal disorders
Productive cough
13.8%
4/29 • Number of events 4 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Skin and subcutaneous tissue disorders
Pruritis
13.8%
4/29 • Number of events 4 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Psychiatric disorders
Psychiatric disorders- other
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Skin and subcutaneous tissue disorders
Rash
3.4%
1/29 • Number of events 2 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Skin and subcutaneous tissue disorders
Rash acneform
3.4%
1/29 • Number of events 2 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Skin and subcutaneous tissue disorders
Rash maculopapular
62.1%
18/29 • Number of events 30 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Renal and urinary disorders
Renal and urinary disorders- other
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Reproductive system and breast disorders
Reproductive system and breast disorders - other
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic, and mediastinal disorders- other
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Nervous system disorders
Sensory neuropathy
27.6%
8/29 • Number of events 9 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Cardiac disorders
Sinus bradycardia
6.9%
2/29 • Number of events 2 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Nervous system disorders
Sinus pain
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Cardiac disorders
Sinus tachycardia
6.9%
2/29 • Number of events 4 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Infections and infestations
Sinusitis
27.6%
8/29 • Number of events 12 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Skin and subcutaneous tissue disorders
Skin and subcutaneous disorders- other (Acne)
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Skin and subcutaneous tissue disorders
Skin and subcutaneous disorders- other (Atypical nevi on right neck and left leg)
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Ear and labyrinth disorders
Tinnitus
6.9%
2/29 • Number of events 2 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Skin and subcutaneous tissue disorders
Skin and subcutaneous disorders- other (brittle crumbling fingernails)
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Skin and subcutaneous tissue disorders
Skin and subcutaneous disorders- other
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Infections and infestations
Tooth infection
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders- other
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders- other (stasis dermatitis)
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Skin and subcutaneous tissue disorders
Skin disorders- other (Red sweat, Chromihidrosis)
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Infections and infestations
Skin infection
13.8%
4/29 • Number of events 4 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Skin and subcutaneous tissue disorders
Skin ulceration
13.8%
4/29 • Number of events 4 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Respiratory, thoracic and mediastinal disorders
Sleep apnea
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Respiratory, thoracic and mediastinal disorders
Sneezing
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Respiratory, thoracic and mediastinal disorders
Sore throat
6.9%
2/29 • Number of events 2 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Gastrointestinal disorders
Stomach pain
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Cardiac disorders
Supraventricular tachycardia
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Surgical and medical procedures
Surgical and medical procedures- other (pain from bunch biopsy)
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Nervous system disorders
Syncope
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Musculoskeletal and connective tissue disorders
Bone pain
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer (invasive ductal carcinoma)
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Reproductive system and breast disorders
Breast pain
6.9%
2/29 • Number of events 3 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Infections and infestations
Bronchial infection
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Injury, poisoning and procedural complications
Bruising
10.3%
3/29 • Number of events 6 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Injury, poisoning and procedural complications
Burn
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Cardiac disorders
Cardiac disorders- other (ascending thoracic aortic aneurysm)
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Cardiac disorders
Cardiac disorders- other (atrial enlargement, bilateral)
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Eye disorders
Cataract
6.9%
2/29 • Number of events 2 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Musculoskeletal and connective tissue disorders
Chest wall pain
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
General disorders
Chills
20.7%
6/29 • Number of events 7 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Hepatobiliary disorders
Cholecystitis
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Investigations
Cholesterol high
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Gastrointestinal disorders
Colitis
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Nervous system disorders
Concentration impairment
10.3%
3/29 • Number of events 3 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Psychiatric disorders
Confusion
10.3%
3/29 • Number of events 5 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Infections and infestations
Conjunctivitis infective
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Gastrointestinal disorders
Constipation
31.0%
9/29 • Number of events 16 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Respiratory, thoracic and mediastinal disorders
Cough
37.9%
11/29 • Number of events 16 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Investigations
Creatinine increased
10.3%
3/29 • Number of events 4 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Metabolism and nutrition disorders
Dehydration
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Gastrointestinal disorders
Abdominal pain
31.0%
9/29 • Number of events 14 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Metabolism and nutrition disorders
Acidosis
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Renal and urinary disorders
Acute kidney injury
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Investigations
Alkaline phosphatase increased
6.9%
2/29 • Number of events 2 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
13.8%
4/29 • Number of events 4 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Skin and subcutaneous tissue disorders
Alopecia
10.3%
3/29 • Number of events 3 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Investigations
ALT increased
27.6%
8/29 • Number of events 13 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Blood and lymphatic system disorders
Anemia
34.5%
10/29 • Number of events 22 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Metabolism and nutrition disorders
Anorexia
24.1%
7/29 • Number of events 9 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Psychiatric disorders
Anxiety
10.3%
3/29 • Number of events 3 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Musculoskeletal and connective tissue disorders
Arthalgia
72.4%
21/29 • Number of events 47 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Musculoskeletal and connective tissue disorders
Arthritis
6.9%
2/29 • Number of events 4 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Investigations
AST increased
24.1%
7/29 • Number of events 9 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Cardiac disorders
Atrial fibrillation
6.9%
2/29 • Number of events 3 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Cardiac disorders
Atrial flutter
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Musculoskeletal and connective tissue disorders
Back pain
20.7%
6/29 • Number of events 12 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Gastrointestinal disorders
Bloating
10.3%
3/29 • Number of events 3 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Investigations
Blood bilirubin increased
13.8%
4/29 • Number of events 11 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Eye disorders
Blurred vision
6.9%
2/29 • Number of events 3 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Treatment related secondary malignancy (Squamous cell carcinoma on hand)
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Nervous system disorders
Tremor
3.4%
1/29 • Number of events 2 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Infections and infestations
Upper respiratory infection
37.9%
11/29 • Number of events 20 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Infections and infestations
Upper respiratory infection (COVID-19)
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Renal and urinary disorders
Urinary frequency
24.1%
7/29 • Number of events 8 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Renal and urinary disorders
Urinary incontinency
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Renal and urinary disorders
Urinary retention
10.3%
3/29 • Number of events 3 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Infections and infestations
Urinary tract infection
13.8%
4/29 • Number of events 6 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Renal and urinary disorders
Urinary urgency
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Skin and subcutaneous tissue disorders
Urticaria
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Reproductive system and breast disorders
Vaginal hemorrhage
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Vascular disorders
Vascular disorders- other (Chronic venous hypertension)
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Ear and labyrinth disorders
Vertigo
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Respiratory, thoracic and mediastinal disorders
Voice alteration
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Gastrointestinal disorders
Vomiting
31.0%
9/29 • Number of events 17 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Eye disorders
Watering eyes
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Investigations
WBC decreased
17.2%
5/29 • Number of events 12 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Investigations
Weight gain
6.9%
2/29 • Number of events 4 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Investigations
Weight loss
3.4%
1/29 • Number of events 1 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.
Respiratory, thoracic and mediastinal disorders
Wheezing
3.4%
1/29 • Number of events 2 • AEs were collected for approximately 8 years and 2 months. AE collection is still ongoing as there are still subjects on treatment.

Additional Information

Ubaldo Martinez-Outschoorn MD

Sidney Kimmel Comprehensive Cancer Center

Phone: 215-955-8874

Results disclosure agreements

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