Trial Outcomes & Findings for ATOP TRIAL: T-DM1 in HER2 Positive Breast Cancer (NCT NCT03587740)
NCT ID: NCT03587740
Last Updated: 2026-05-18
Results Overview
IDFS is defined as the time from the first T-DM1 dose to ipsilateral invasive breast cancer recurrence, regional invasive breast cancer recurrence, distant recurrence, death due to any cause, contralateral invasive breast cancer, or a second non-breast primary cancer, whichever occurs first. Patients without one of these events at the time of data analysis will be censored at the date last known to be alive and event-free. Survival probabilities (reported as percentages) are estimated from Kaplan Meier methods.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
111 participants
Primary outcome timeframe
5 years
Results posted on
2026-05-18
Participant Flow
Participant milestones
| Measure |
T-DM1
T-DM1 will be administered every 3 weeks intravenously, with 21 consecutive days defined as a treatment.
T-DM1: T-DM1 is an antibody-drug conjugate; it is made up of an antibody (trastuzumab) linked to a cytotoxic drug, DM1 (chemotherapy). T-DM1 functions as a targeted cancer therapy because it targets HER2-positive breast cancer cells directly, limiting exposure of the rest of the body to chemotherapy.
|
|---|---|
|
Overall Study
STARTED
|
111
|
|
Overall Study
COMPLETED
|
111
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
This study was composed two sets of participants: one set of participants were previously enrolled in a prior study and were re-enrolled into this study for further long-term follow-up, and one set were newly enrolled into this study. Some demographic information for some subjects who were re-enrolled into this study were not adequately shared by the prior study team, and attempts to retrieve this demographic data were not successful.
Baseline characteristics by cohort
| Measure |
T-DM1
n=111 Participants
T-DM1 will be administered every 3 weeks intravenously, with 21 consecutive days defined as a treatment.
T-DM1: T-DM1 is an antibody-drug conjugate; it is made up of an antibody (trastuzumab) linked to a cytotoxic drug, DM1 (chemotherapy). T-DM1 functions as a targeted cancer therapy because it targets HER2-positive breast cancer cells directly, limiting exposure of the rest of the body to chemotherapy.
|
|---|---|
|
Age, Continuous
|
71 Years
n=111 Participants
|
|
Age, Customized
Age at enrollment · 60 to 65 years
|
33 Participants
n=111 Participants
|
|
Age, Customized
Age at enrollment · 66 to 70 years
|
22 Participants
n=111 Participants
|
|
Age, Customized
Age at enrollment · 71 to 75 years
|
25 Participants
n=111 Participants
|
|
Age, Customized
Age at enrollment · 76 to 80 years
|
18 Participants
n=111 Participants
|
|
Age, Customized
Age at enrollment · Over 80 years
|
13 Participants
n=111 Participants
|
|
Sex: Female, Male
Female
|
102 Participants
n=103 Participants • This study was composed two sets of participants: one set of participants were previously enrolled in a prior study and were re-enrolled into this study for further long-term follow-up, and one set were newly enrolled into this study. Some demographic information for some subjects who were re-enrolled into this study were not adequately shared by the prior study team, and attempts to retrieve this demographic data were not successful.
|
|
Sex: Female, Male
Male
|
1 Participants
n=103 Participants • This study was composed two sets of participants: one set of participants were previously enrolled in a prior study and were re-enrolled into this study for further long-term follow-up, and one set were newly enrolled into this study. Some demographic information for some subjects who were re-enrolled into this study were not adequately shared by the prior study team, and attempts to retrieve this demographic data were not successful.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=111 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
83 Participants
n=111 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
26 Participants
n=111 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
3 Participants
n=111 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
5 Participants
n=111 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
79 Participants
n=111 Participants
|
|
Race/Ethnicity, Customized
Race · Other or Unknown
|
24 Participants
n=111 Participants
|
|
ECOG Performance Status
0 (fFully active; able to carry out all pre-disease activities without restriction)
|
88 Participants
n=111 Participants
|
|
ECOG Performance Status
1 (Restricted in physically strenuous activity, but ambulatory and able to carry out light work)
|
21 Participants
n=111 Participants
|
|
ECOG Performance Status
2 (Ambulatory and capable of all self-care, but unable to carry out any work activities)
|
2 Participants
n=111 Participants
|
|
Clinical stage at primary breast cancer diagnosis
Stage I
|
77 Participants
n=111 Participants
|
|
Clinical stage at primary breast cancer diagnosis
Stage II
|
29 Participants
n=111 Participants
|
|
Clinical stage at primary breast cancer diagnosis
Stage III
|
5 Participants
n=111 Participants
|
|
Tumor size (cm) - largest pathologic focus of primary invasive tumor
<1 cm
|
22 Participants
n=111 Participants
|
|
Tumor size (cm) - largest pathologic focus of primary invasive tumor
1-2 cm
|
56 Participants
n=111 Participants
|
|
Tumor size (cm) - largest pathologic focus of primary invasive tumor
2-5 cm
|
29 Participants
n=111 Participants
|
|
Tumor size (cm) - largest pathologic focus of primary invasive tumor
>5 cm
|
4 Participants
n=111 Participants
|
|
Hormone receptor status
Negative
|
33 Participants
n=111 Participants
|
|
Hormone receptor status
Positive
|
78 Participants
n=111 Participants
|
PRIMARY outcome
Timeframe: 5 yearsPopulation: All patients who received at least one dose of T-DM1 treatment.
IDFS is defined as the time from the first T-DM1 dose to ipsilateral invasive breast cancer recurrence, regional invasive breast cancer recurrence, distant recurrence, death due to any cause, contralateral invasive breast cancer, or a second non-breast primary cancer, whichever occurs first. Patients without one of these events at the time of data analysis will be censored at the date last known to be alive and event-free. Survival probabilities (reported as percentages) are estimated from Kaplan Meier methods.
Outcome measures
| Measure |
T-DM1
n=111 Participants
T-DM1 will be administered every 3 weeks intravenously, with 21 consecutive days defined as a treatment.
T-DM1: T-DM1 is an antibody-drug conjugate; it is made up of an antibody (trastuzumab) linked to a cytotoxic drug, DM1 (chemotherapy). T-DM1 functions as a targeted cancer therapy because it targets HER2-positive breast cancer cells directly, limiting exposure of the rest of the body to chemotherapy.
|
|---|---|
|
Invasive Disease-free Survival Rate (IDFS)
Survival percent probability at 5 years
|
84.2 Survival percent probability
Interval 77.1 to 92.0
|
|
Invasive Disease-free Survival Rate (IDFS)
Survival percent probability at 3 years
|
91.2 Survival percent probability
Interval 85.9 to 96.9
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: All patients who received at least one dose of T-DM1 treatment.
IBCFS is defined as the time from the first T-DM1 dose to ipsilateral invasive breast cancer recurrence, regional invasive breast cancer recurrence, distant recurrence, death due to any cause, or contralateral invasive breast cancer, whichever occurs first. Patients who experience a second non-breast new primary outcome will be censored at their new primary diagnosis date. Patients without any of these events at the time of data analysis will be censored at the date last known to be alive and event-free. Survival probabilities (reported as percentages) are estimated from Kaplan Meier methods.
Outcome measures
| Measure |
T-DM1
n=111 Participants
T-DM1 will be administered every 3 weeks intravenously, with 21 consecutive days defined as a treatment.
T-DM1: T-DM1 is an antibody-drug conjugate; it is made up of an antibody (trastuzumab) linked to a cytotoxic drug, DM1 (chemotherapy). T-DM1 functions as a targeted cancer therapy because it targets HER2-positive breast cancer cells directly, limiting exposure of the rest of the body to chemotherapy.
|
|---|---|
|
Invasive Breast Cancer-free Survival (IBCFS)
Survival percent probability at 5 years
|
92.0 Survival percent probability
Interval 86.9 to 97.5
|
|
Invasive Breast Cancer-free Survival (IBCFS)
Survival percent probability at 3 years
|
94.1 Survival percent probability
Interval 89.7 to 98.8
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: All patients who received at least one dose of T-DM1 treatment
RFI is defined as the time from the first T-DM1 dose to ipsilateral invasive breast cancer recurrence, regional invasive breast cancer recurrence, or distant recurrence. Patients who experience other IDFS events, such as contralateral invasive breast cancer, a second non-breast primary cancer, or death due to any cause, will be censored at the time of these events. Patients without any of these events at the time of data analysis will be censored at the date last known to be alive and event-free. Survival probabilities (reported as percentages) are estimated from Kaplan Meier methods. Note: The protocol labels this outcome as recurrence-free survival (RFS). However, the definition provided in the protocol, where the recurrences are considered events but deaths are not considered events, matches the definition of recurrence-free interval (RFI) provided in the STEEP version 2.0 paper (Tolaney et al., 2021).
Outcome measures
| Measure |
T-DM1
n=111 Participants
T-DM1 will be administered every 3 weeks intravenously, with 21 consecutive days defined as a treatment.
T-DM1: T-DM1 is an antibody-drug conjugate; it is made up of an antibody (trastuzumab) linked to a cytotoxic drug, DM1 (chemotherapy). T-DM1 functions as a targeted cancer therapy because it targets HER2-positive breast cancer cells directly, limiting exposure of the rest of the body to chemotherapy.
|
|---|---|
|
Recurrence-free Interval (RFI)
Survival percent probability at 5 years
|
94.9 Survival percent probability
Interval 90.6 to 99.4
|
|
Recurrence-free Interval (RFI)
Survival percent probability at 3 years
|
95.9 Survival percent probability
Interval 92.1 to 99.9
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: All patients who received at least one dose of T-DM1 treatment.
OS defined as the time from the first T-DM1 dose to death attributable to any cause (i.e. death from breast cancer, non-breast cancer cause, or from unknown cause). Subjects alive at the time of data analysis (including those lost to follow-up) will be censored at the last known alive date. Survival probabilities (reported as percentages) estimated from Kaplan Meier methods.
Outcome measures
| Measure |
T-DM1
n=111 Participants
T-DM1 will be administered every 3 weeks intravenously, with 21 consecutive days defined as a treatment.
T-DM1: T-DM1 is an antibody-drug conjugate; it is made up of an antibody (trastuzumab) linked to a cytotoxic drug, DM1 (chemotherapy). T-DM1 functions as a targeted cancer therapy because it targets HER2-positive breast cancer cells directly, limiting exposure of the rest of the body to chemotherapy.
|
|---|---|
|
Overall Survival (OS)
Survival percent probability at 5 years
|
93.3 Survival percent probability
Interval 88.1 to 98.9
|
|
Overall Survival (OS)
Survival percent probability at 3 years
|
96.1 Survival percent probability
Interval 92.4 to 99.9
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: All patients who received at least one dose of T-DM1 treatment.
The site of the first IDFS event for patients receiving T-DM1, which will be tabulated as frequencies and relative frequencies. IDFS events include ipsilateral invasive breast cancer recurrence, regional invasive breast cancer recurrence, distant recurrence, death due to any cause, contralateral invasive breast cancer, or a second non-breast primary cancer.
Outcome measures
| Measure |
T-DM1
n=111 Participants
T-DM1 will be administered every 3 weeks intravenously, with 21 consecutive days defined as a treatment.
T-DM1: T-DM1 is an antibody-drug conjugate; it is made up of an antibody (trastuzumab) linked to a cytotoxic drug, DM1 (chemotherapy). T-DM1 functions as a targeted cancer therapy because it targets HER2-positive breast cancer cells directly, limiting exposure of the rest of the body to chemotherapy.
|
|---|---|
|
Site of First Recurrence
Ipsilateral invasive breast cancer
|
1 Participants
|
|
Site of First Recurrence
Regional invasive breast cancer
|
0 Participants
|
|
Site of First Recurrence
Contralateral invasive breast cancer
|
3 Participants
|
|
Site of First Recurrence
Distant recurrence
|
3 Participants
|
|
Site of First Recurrence
Non-breast new primary invasive cancer
|
7 Participants
|
|
Site of First Recurrence
Death due to breast cancer
|
2 Participants
|
|
Site of First Recurrence
Death due to other non-breast cancer reason
|
1 Participants
|
|
Site of First Recurrence
Alive and event-free at last follow-up
|
94 Participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: All patients who received at least one dose of T-DM1 treatment.
Among all patients who received at least one dose of T-DM1 treatment, summarize the maximum treatment-related adverse event reported per subject. Adverse events (AEs) are graded utilizing CTCAE v4.0; AEs of grade 2 to 5 are systematically reported, while grade 1 AEs are not systematically reported, so subjects with no reported AEs (grade 0) and subjects with a maximum grade 1 AE are combined into a single category. AEs are considered treatment-related if they start at or after the first dose of T-DM1 and are determined to be definitely, possibly, or probably related to T-DM1 treatment.
Outcome measures
| Measure |
T-DM1
n=111 Participants
T-DM1 will be administered every 3 weeks intravenously, with 21 consecutive days defined as a treatment.
T-DM1: T-DM1 is an antibody-drug conjugate; it is made up of an antibody (trastuzumab) linked to a cytotoxic drug, DM1 (chemotherapy). T-DM1 functions as a targeted cancer therapy because it targets HER2-positive breast cancer cells directly, limiting exposure of the rest of the body to chemotherapy.
|
|---|---|
|
Incidence Rate of All Toxicities (Safety)
Grade 4 (life-threatening)
|
1 Participants
|
|
Incidence Rate of All Toxicities (Safety)
Grade 2 (moderate)
|
59 Participants
|
|
Incidence Rate of All Toxicities (Safety)
Grade 3 (severe)
|
31 Participants
|
|
Incidence Rate of All Toxicities (Safety)
Grade 5 (death related to toxicity)
|
0 Participants
|
|
Incidence Rate of All Toxicities (Safety)
Grade 0 (no toxicity) or grade 1 (mild)
|
20 Participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: All patients who received at least one dose of T-DM1 treatment.
Incidence of symptomatic left ventricular systolic dysfunction in patients receiving T-DM1, recorded as frequencies and percentages.
Outcome measures
| Measure |
T-DM1
n=111 Participants
T-DM1 will be administered every 3 weeks intravenously, with 21 consecutive days defined as a treatment.
T-DM1: T-DM1 is an antibody-drug conjugate; it is made up of an antibody (trastuzumab) linked to a cytotoxic drug, DM1 (chemotherapy). T-DM1 functions as a targeted cancer therapy because it targets HER2-positive breast cancer cells directly, limiting exposure of the rest of the body to chemotherapy.
|
|---|---|
|
Incidence Rate of Cardiac-Related Adverse Events: Left Ventricular Systolic Dysfunction
No symptom of left ventricular systolic dysfunction observed
|
107 Participants
|
|
Incidence Rate of Cardiac-Related Adverse Events: Left Ventricular Systolic Dysfunction
Symptom of left ventricular systolic dysfunction observed
|
4 Participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: All patients who received at least one dose of T-DM1 treatment.
Incidence of deaths due to a cardiac event in patients receiving T-DM1, recorded as frequencies and percentages.
Outcome measures
| Measure |
T-DM1
n=111 Participants
T-DM1 will be administered every 3 weeks intravenously, with 21 consecutive days defined as a treatment.
T-DM1: T-DM1 is an antibody-drug conjugate; it is made up of an antibody (trastuzumab) linked to a cytotoxic drug, DM1 (chemotherapy). T-DM1 functions as a targeted cancer therapy because it targets HER2-positive breast cancer cells directly, limiting exposure of the rest of the body to chemotherapy.
|
|---|---|
|
Incidence Rate of Cardiac-Related Adverse Events: Cardiac Death
Cardiac death
|
0 Participants
|
|
Incidence Rate of Cardiac-Related Adverse Events: Cardiac Death
Death not observed in follow-up or death due to non-cardiac cause
|
111 Participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: All patients who received at least one dose of T-DM1 treatment.
Incidence of a decrease in ejection fraction by at least 10 percentage points below baseline (measured by an absolute difference) or an ejection fraction below 50%.
Outcome measures
| Measure |
T-DM1
n=111 Participants
T-DM1 will be administered every 3 weeks intravenously, with 21 consecutive days defined as a treatment.
T-DM1: T-DM1 is an antibody-drug conjugate; it is made up of an antibody (trastuzumab) linked to a cytotoxic drug, DM1 (chemotherapy). T-DM1 functions as a targeted cancer therapy because it targets HER2-positive breast cancer cells directly, limiting exposure of the rest of the body to chemotherapy.
|
|---|---|
|
Incidence Rate of Cardiac-Related Adverse Events: Decreased Ejection Fraction
Decrease in ejection fraction by at least 10 percentage points below baseline
|
11 Participants
|
|
Incidence Rate of Cardiac-Related Adverse Events: Decreased Ejection Fraction
Ejection fraction decreased below 50%
|
1 Participants
|
|
Incidence Rate of Cardiac-Related Adverse Events: Decreased Ejection Fraction
No ejection fraction cardiac toxicity observed
|
99 Participants
|
Adverse Events
T-DM1
Serious events: 17 serious events
Other events: 111 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
T-DM1
n=111 participants at risk
T-DM1 will be administered every 3 weeks intravenously, with 21 consecutive days defined as a treatment.
T-DM1: T-DM1 is an antibody-drug conjugate; it is made up of an antibody (trastuzumab) linked to a cytotoxic drug, DM1 (chemotherapy). T-DM1 functions as a targeted cancer therapy because it targets HER2-positive breast cancer cells directly, limiting exposure of the rest of the body to chemotherapy.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Gastrointestinal disorders
Colitis
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
General disorders
Fatigue
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
General disorders
Fever
|
1.8%
2/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Infections and infestations
Bladder infection
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Infections and infestations
Breast infection
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Infections and infestations
Enterocolitis infectious
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Infections and infestations
Infections and infestations - Other, specify
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Infections and infestations
Lung infection
|
1.8%
2/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Infections and infestations
Skin infection
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Infections and infestations
Urinary tract infection
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Injury, poisoning and procedural complications
Fall
|
1.8%
2/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Injury, poisoning and procedural complications
Fracture
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Investigations
Ejection fraction decreased
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Investigations
Platelet count decreased
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Nervous system disorders
Encephalopathy
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Nervous system disorders
Headache
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Nervous system disorders
Seizure
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Nervous system disorders
Syncope
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Psychiatric disorders
Confusion
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
Other adverse events
| Measure |
T-DM1
n=111 participants at risk
T-DM1 will be administered every 3 weeks intravenously, with 21 consecutive days defined as a treatment.
T-DM1: T-DM1 is an antibody-drug conjugate; it is made up of an antibody (trastuzumab) linked to a cytotoxic drug, DM1 (chemotherapy). T-DM1 functions as a targeted cancer therapy because it targets HER2-positive breast cancer cells directly, limiting exposure of the rest of the body to chemotherapy.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
25.2%
28/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Cardiac disorders
Atrial fibrillation
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Cardiac disorders
Chest pain - cardiac
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Cardiac disorders
Palpitations
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Cardiac disorders
Sinus bradycardia
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Cardiac disorders
Supraventricular tachycardia
|
1.8%
2/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Ear and labyrinth disorders
Ear pain
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Ear and labyrinth disorders
Tinnitus
|
1.8%
2/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Ear and labyrinth disorders
Vertigo
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Endocrine disorders
Hypothyroidism
|
1.8%
2/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Eye disorders
Blurred vision
|
24.3%
27/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Eye disorders
Cataract
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Eye disorders
Conjunctivitis
|
1.8%
2/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Eye disorders
Dry eye
|
10.8%
12/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Eye disorders
Eye disorders - Other, specify
|
8.1%
9/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Eye disorders
Eye pain
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Eye disorders
Flashing lights
|
6.3%
7/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Eye disorders
Floaters
|
13.5%
15/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Eye disorders
Watering eyes
|
28.8%
32/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Gastrointestinal disorders
Abdominal pain
|
8.1%
9/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Gastrointestinal disorders
Bloating
|
1.8%
2/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Gastrointestinal disorders
Constipation
|
37.8%
42/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Gastrointestinal disorders
Diarrhea
|
27.0%
30/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Gastrointestinal disorders
Dry mouth
|
55.9%
62/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Gastrointestinal disorders
Dyspepsia
|
7.2%
8/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
1.8%
2/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
6.3%
7/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
1.8%
2/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Gastrointestinal disorders
Lip pain
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Gastrointestinal disorders
Mucositis oral
|
23.4%
26/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Gastrointestinal disorders
Nausea
|
58.6%
65/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Gastrointestinal disorders
Oral dysesthesia
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Gastrointestinal disorders
Oral hemorrhage
|
1.8%
2/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Gastrointestinal disorders
Oral pain
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
1.8%
2/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Gastrointestinal disorders
Stomach pain
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Gastrointestinal disorders
Toothache
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Gastrointestinal disorders
Vomiting
|
13.5%
15/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
General disorders
Chills
|
12.6%
14/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
General disorders
Edema face
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
General disorders
Edema limbs
|
7.2%
8/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
General disorders
Facial pain
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
General disorders
Fatigue
|
82.9%
92/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
General disorders
Fever
|
9.9%
11/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
General disorders
Flu like symptoms
|
8.1%
9/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
3.6%
4/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
General disorders
Infusion related reaction
|
2.7%
3/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
General disorders
Infusion site extravasation
|
1.8%
2/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
General disorders
Localized edema
|
2.7%
3/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
General disorders
Malaise
|
1.8%
2/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
General disorders
Non-cardiac chest pain
|
7.2%
8/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
General disorders
Pain
|
28.8%
32/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Hepatobiliary disorders
Portal hypertension
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Immune system disorders
Allergic reaction
|
1.8%
2/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Immune system disorders
Autoimmune disorder
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Infections and infestations
Breast infection
|
1.8%
2/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Infections and infestations
Bronchial infection
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Infections and infestations
Device related infection
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Infections and infestations
Eye infection
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Infections and infestations
Gum infection
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Infections and infestations
Infections and infestations - Other, specify
|
3.6%
4/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Infections and infestations
Lip infection
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Infections and infestations
Lung infection
|
2.7%
3/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Infections and infestations
Mucosal infection
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Infections and infestations
Otitis media
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Infections and infestations
Papulopustular rash
|
2.7%
3/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Infections and infestations
Rhinitis infective
|
2.7%
3/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Infections and infestations
Skin infection
|
6.3%
7/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Infections and infestations
Soft tissue infection
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Infections and infestations
Tooth infection
|
1.8%
2/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Infections and infestations
Upper respiratory infection
|
4.5%
5/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Infections and infestations
Urinary tract infection
|
12.6%
14/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Infections and infestations
Uterine infection
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Infections and infestations
Vaginal infection
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Injury, poisoning and procedural complications
Bruising
|
20.7%
23/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Injury, poisoning and procedural complications
Burn
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
11.7%
13/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Injury, poisoning and procedural complications
Fall
|
4.5%
5/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Injury, poisoning and procedural complications
Seroma
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Investigations
Alanine aminotransferase increased
|
50.5%
56/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Investigations
Alkaline phosphatase increased
|
31.5%
35/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Investigations
Aspartate aminotransferase increased
|
73.9%
82/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Investigations
Blood bilirubin increased
|
18.0%
20/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Investigations
Creatinine increased
|
7.2%
8/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Investigations
Investigations - Other, specify
|
2.7%
3/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Investigations
Lymphocyte count decreased
|
13.5%
15/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Investigations
Neutrophil count decreased
|
16.2%
18/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Investigations
Platelet count decreased
|
46.8%
52/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Investigations
Weight loss
|
15.3%
17/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Investigations
White blood cell decreased
|
9.9%
11/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Metabolism and nutrition disorders
Anorexia
|
47.7%
53/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Metabolism and nutrition disorders
Dehydration
|
2.7%
3/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
11.7%
13/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
16.2%
18/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
2.7%
3/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
6.3%
7/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
3.6%
4/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Metabolism and nutrition disorders
Hypokalemia
|
25.2%
28/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
1.8%
2/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
13.5%
15/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
6.3%
7/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Metabolism and nutrition disorders
Obesity
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
22.5%
25/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.8%
2/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.2%
8/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
3.6%
4/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
1.8%
2/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
3.6%
4/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
1.8%
2/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
45.0%
50/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.8%
2/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
2.7%
3/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.6%
14/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Nervous system disorders
Ataxia
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Nervous system disorders
Concentration impairment
|
3.6%
4/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Nervous system disorders
Dizziness
|
9.9%
11/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Nervous system disorders
Dysesthesia
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Nervous system disorders
Dysgeusia
|
20.7%
23/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Nervous system disorders
Headache
|
41.4%
46/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Nervous system disorders
Hypersomnia
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Nervous system disorders
Memory impairment
|
3.6%
4/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Nervous system disorders
Movements involuntary
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Nervous system disorders
Neuralgia
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Nervous system disorders
Olfactory nerve disorder
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Nervous system disorders
Paresthesia
|
5.4%
6/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Nervous system disorders
Peripheral motor neuropathy
|
8.1%
9/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
57.7%
64/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Nervous system disorders
Seizure
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Nervous system disorders
Syncope
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Nervous system disorders
Tremor
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Psychiatric disorders
Anxiety
|
9.9%
11/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Psychiatric disorders
Confusion
|
1.8%
2/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Psychiatric disorders
Depression
|
1.8%
2/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Psychiatric disorders
Insomnia
|
38.7%
43/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Psychiatric disorders
Restlessness
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Renal and urinary disorders
Hematuria
|
2.7%
3/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
1.8%
2/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Renal and urinary disorders
Renal calculi
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Renal and urinary disorders
Urinary frequency
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Renal and urinary disorders
Urinary retention
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Renal and urinary disorders
Urinary tract pain
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Reproductive system and breast disorders
Breast pain
|
7.2%
8/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Reproductive system and breast disorders
Dyspareunia
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Reproductive system and breast disorders
Irregular menstruation
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other, specify
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Reproductive system and breast disorders
Vaginal dryness
|
1.8%
2/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
5.4%
6/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
30.6%
34/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
24.3%
27/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
47.7%
53/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
4.5%
5/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.8%
2/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.3%
7/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
4.5%
5/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
2.7%
3/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
3.6%
4/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
2.7%
3/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
4.5%
5/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.4%
6/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
4.5%
5/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
9.0%
10/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
8.1%
9/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
18.0%
20/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.5%
5/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
19.8%
22/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
3.6%
4/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Skin and subcutaneous tissue disorders
Skin/subcutaneous tissue disorders; Other, specify
|
4.5%
5/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
5.4%
6/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Vascular disorders
Hematoma
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Vascular disorders
Hot flashes
|
9.0%
10/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Vascular disorders
Hypertension
|
25.2%
28/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Vascular disorders
Hypotension
|
2.7%
3/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Vascular disorders
Lymphedema
|
0.90%
1/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
|
Vascular disorders
Thromboembolic event
|
1.8%
2/111 • Adverse Events were assessed up to 2 years. Deaths were assessed up to 5 years.
Regular investigator assessment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place