Trial Outcomes & Findings for Zandelisib (ME-401) in Subjects With Follicular Lymphoma or Marginal Zone Lymphoma After Failure of Two or More Prior Therapies (TIDAL) (NCT NCT03768505)
NCT ID: NCT03768505
Last Updated: 2024-12-31
Results Overview
ORR is measured as the proportion of subjects achieving the best response rating of CR or PR prior to first PD
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
169 participants
Primary outcome timeframe
3 years 9 months
Results posted on
2024-12-31
Participant Flow
This Phase 2 study was open from June 2019 to March 2023 at 124 investigational sites in the United States, United Kingdom, Spain, New Zealand, Austria, South Korea, Belgium, Taiwan, Poland, Italy, Australia, France, Germany. This study was closed prematurely for business reasons . A total of 169 subjects were enrolled. The reasons for subjects not completing the study are listed below. The majority was due to study closure by sponsor.
Participant milestones
| Measure |
Zandelisib (ME-401) Open Label
Subjects with relapsed/refractory FL or MZL were administered 60 mg of ME-401 orally, once a day on an intermittent schedule (IS).
Zandelisib (ME-401): Zandelisib (ME-401) 60 mg
|
|---|---|
|
Overall Study
STARTED
|
169
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
169
|
Reasons for withdrawal
| Measure |
Zandelisib (ME-401) Open Label
Subjects with relapsed/refractory FL or MZL were administered 60 mg of ME-401 orally, once a day on an intermittent schedule (IS).
Zandelisib (ME-401): Zandelisib (ME-401) 60 mg
|
|---|---|
|
Overall Study
sponsor decision
|
76
|
|
Overall Study
Death
|
35
|
|
Overall Study
Other -Various
|
30
|
|
Overall Study
Withdrawal by Subject
|
22
|
|
Overall Study
Lost to Follow-up
|
6
|
Baseline Characteristics
Zandelisib (ME-401) in Subjects With Follicular Lymphoma or Marginal Zone Lymphoma After Failure of Two or More Prior Therapies (TIDAL)
Baseline characteristics by cohort
| Measure |
Zandelisib (ME-401) Open Label
n=169 Participants
Subjects with relapsed/refractory FL or MZL will be administered 60 mg of ME-401 orally, once a day on an intermittent schedule (IS).
Zandelisib (ME-401): Zandelisib (ME-401) 60 mg
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
79 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
90 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
63 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
106 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
144 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
129 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
15 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
34 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
8 participants
n=5 Participants
|
|
Region of Enrollment
New Zealand
|
5 participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
3 participants
n=5 Participants
|
|
Region of Enrollment
South Korea
|
15 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
8 participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
7 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
18 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
21 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
8 participants
n=5 Participants
|
|
Region of Enrollment
France
|
12 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 years 9 monthsPopulation: A company decision was made to terminate all Zandelisib studies early due to business reasons including this Phase 2 study. Due to the study being terminated early, no data was collected to analyze ORR
ORR is measured as the proportion of subjects achieving the best response rating of CR or PR prior to first PD
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 years 9 monthsPopulation: A company decision was made to terminate all Zandelisib studies early due to business reasons including this Phase 2 study. Due to the study being terminated early, no data was collected to analyze DOR
Duration of Response will be measured as the time from documentation from CR or PR to time of disease progression
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 years 9 monthsPopulation: A company decision was made to terminate all Zandelisib studies early due to business reasons including this Phase 2 study. Due to the study being terminated early, no data was collected to analyze CR
Complete response rate will be measured by the number of subjects that achieve CR
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 years 9 monthsPopulation: A company decision was made to terminate all Zandelisib studies early due to business reasons including this Phase 2 study. Due to the study being terminated early, no data was collected to analyze PFS.
Progression-free survival will be measurement of time from initiation of treatment (Day 1) until disease progression or death
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsPopulation: Study was terminated early, therefore data was not available to measure OS at time of termination
Overall survival will be measured as the time from initiation of treatment (Day 1) until death
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 years 9 monthsThe incidence of TEAEs is measured by the proportion of subjects with at least one TEAE.
Outcome measures
| Measure |
Zandelisib (ME-401) Open Label
n=162 Participants
Subjects with relapsed/refractory FL or MZL were administered 60 mg of ME-401 orally, once a day on an intermittent schedule (IS).
Zandelisib (ME-401): Zandelisib (ME-401) 60 mg
|
|---|---|
|
Overall Incidence of Treatment Emergent Adverse Events (TEAEs)
|
162 Participants
|
SECONDARY outcome
Timeframe: 3 years 9 monthsPopulation: A company decision was made to terminate all Zandelisib studies early due to business reasons including this Phase 2 study. Due to the study being terminated early, no data was collected to analyze PK
The PK of ME-401 will be determined by the peak plasma concentration (Cmax)
Outcome measures
Outcome data not reported
Adverse Events
Zandelisib (ME-401) Open Label
Serious events: 69 serious events
Other events: 162 other events
Deaths: 35 deaths
Serious adverse events
| Measure |
Zandelisib (ME-401) Open Label
n=169 participants at risk
Subjects with relapsed/refractory FL or MZL will be administered 60 mg of ME-401 orally, once a day on an intermittent schedule (IS).
Zandelisib (ME-401): Zandelisib (ME-401) 60 mg
|
|---|---|
|
Infections and infestations
Pneumonia
|
4.7%
8/169 • Number of events 8 • AEs were collected for 3 years 9 months
|
|
Infections and infestations
COVID-19 pneumonia
|
3.6%
6/169 • Number of events 6 • AEs were collected for 3 years 9 months
|
|
Infections and infestations
COVID-19
|
2.4%
4/169 • Number of events 4 • AEs were collected for 3 years 9 months
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
1.8%
3/169 • Number of events 3 • AEs were collected for 3 years 9 months
|
|
Infections and infestations
Lower respiratory tract infection
|
1.2%
2/169 • Number of events 2 • AEs were collected for 3 years 9 months
|
|
Infections and infestations
Urinary tract infection
|
1.2%
2/169 • Number of events 2 • AEs were collected for 3 years 9 months
|
|
Infections and infestations
Arthritis bacterial
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Infections and infestations
Aspergillus infection
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Infections and infestations
Bronchitis
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Infections and infestations
Conjunctivitis bacterial
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Infections and infestations
Cytomegalovirus colitis
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Infections and infestations
Diverticulitis
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Infections and infestations
Herpes simplex
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Infections and infestations
Neutropenic sepsis
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Infections and infestations
Pneumonia viral
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Infections and infestations
Pseudomonal sepsis
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Infections and infestations
Pyelonephritis
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Infections and infestations
Respiratory tract infection
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Infections and infestations
Sinusitis bacterial
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Infections and infestations
Upper respiratory tract infection
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Gastrointestinal disorders
Colitis
|
2.4%
4/169 • Number of events 4 • AEs were collected for 3 years 9 months
|
|
Gastrointestinal disorders
Diarrhoea
|
2.4%
4/169 • Number of events 4 • AEs were collected for 3 years 9 months
|
|
Gastrointestinal disorders
Abdominal pain
|
1.2%
2/169 • Number of events 2 • AEs were collected for 3 years 9 months
|
|
Gastrointestinal disorders
Stomatitis
|
1.2%
2/169 • Number of events 2 • AEs were collected for 3 years 9 months
|
|
Gastrointestinal disorders
Autoimmune enteropathy
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Gastrointestinal disorders
Enterocolitis
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.2%
2/169 • Number of events 2 • AEs were collected for 3 years 9 months
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
1.2%
2/169 • Number of events 2 • AEs were collected for 3 years 9 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.2%
2/169 • Number of events 2 • AEs were collected for 3 years 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.2%
2/169 • Number of events 2 • AEs were collected for 3 years 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.2%
2/169 • Number of events 2 • AEs were collected for 3 years 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
General disorders
Pyrexia
|
2.4%
4/169 • Number of events 4 • AEs were collected for 3 years 9 months
|
|
General disorders
Mucosal inflammation
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
General disorders
Systemic inflammatory response syndrome
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Cardiac disorders
Cardiac failure
|
1.2%
2/169 • Number of events 2 • AEs were collected for 3 years 9 months
|
|
Cardiac disorders
Atrioventricular block complete
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Cardiac disorders
Cardiac arrest
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Cardiac disorders
Hypertensive cardiomyopathy
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.2%
2/169 • Number of events 2 • AEs were collected for 3 years 9 months
|
|
Blood and lymphatic system disorders
Anaemia
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Investigations
Blood creatinine increased
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Investigations
C-reactive protein increased
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Investigations
Platelet count decreased
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Nervous system disorders
Cerebrovascular accident
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Nervous system disorders
Toxic encephalopathy
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Psychiatric disorders
Confusional state
|
1.8%
3/169 • Number of events 3 • AEs were collected for 3 years 9 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Renal and urinary disorders
Acute kidney injury
|
1.2%
2/169 • Number of events 2 • AEs were collected for 3 years 9 months
|
|
Eye disorders
Uveitis
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Hepatobiliary disorders
Hepatitis
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
Other adverse events
| Measure |
Zandelisib (ME-401) Open Label
n=169 participants at risk
Subjects with relapsed/refractory FL or MZL will be administered 60 mg of ME-401 orally, once a day on an intermittent schedule (IS).
Zandelisib (ME-401): Zandelisib (ME-401) 60 mg
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
39.1%
66/169 • Number of events 66 • AEs were collected for 3 years 9 months
|
|
Gastrointestinal disorders
Nausea
|
22.5%
38/169 • Number of events 38 • AEs were collected for 3 years 9 months
|
|
Gastrointestinal disorders
Abdominal pain
|
14.2%
24/169 • Number of events 24 • AEs were collected for 3 years 9 months
|
|
Gastrointestinal disorders
Constipation
|
13.0%
22/169 • Number of events 22 • AEs were collected for 3 years 9 months
|
|
Gastrointestinal disorders
Vomiting
|
6.5%
11/169 • Number of events 11 • AEs were collected for 3 years 9 months
|
|
Gastrointestinal disorders
Dyspepsia
|
5.9%
10/169 • Number of events 10 • AEs were collected for 3 years 9 months
|
|
Gastrointestinal disorders
Stomatitis
|
5.3%
9/169 • Number of events 9 • AEs were collected for 3 years 9 months
|
|
Gastrointestinal disorders
Colitis
|
3.6%
6/169 • Number of events 6 • AEs were collected for 3 years 9 months
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
4.1%
7/169 • Number of events 7 • AEs were collected for 3 years 9 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.6%
6/169 • Number of events 6 • AEs were collected for 3 years 9 months
|
|
Gastrointestinal disorders
Dry mouth
|
3.0%
5/169 • Number of events 5 • AEs were collected for 3 years 9 months
|
|
Gastrointestinal disorders
Flatulence
|
2.4%
4/169 • Number of events 4 • AEs were collected for 3 years 9 months
|
|
Gastrointestinal disorders
Abdominal pain lower
|
1.8%
3/169 • Number of events 3 • AEs were collected for 3 years 9 months
|
|
Gastrointestinal disorders
Gastritis
|
1.8%
3/169 • Number of events 3 • AEs were collected for 3 years 9 months
|
|
Gastrointestinal disorders
Toothache
|
1.8%
3/169 • Number of events 3 • AEs were collected for 3 years 9 months
|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.2%
2/169 • Number of events 2 • AEs were collected for 3 years 9 months
|
|
Gastrointestinal disorders
Abdominal distension
|
1.2%
2/169 • Number of events 2 • AEs were collected for 3 years 9 months
|
|
Gastrointestinal disorders
Dental caries
|
1.2%
2/169 • Number of events 2 • AEs were collected for 3 years 9 months
|
|
Gastrointestinal disorders
Eructation
|
1.2%
2/169 • Number of events 2 • AEs were collected for 3 years 9 months
|
|
Gastrointestinal disorders
Glossodynia
|
1.2%
2/169 • Number of events 2 • AEs were collected for 3 years 9 months
|
|
Gastrointestinal disorders
Haemorrhoids
|
1.2%
2/169 • Number of events 2 • AEs were collected for 3 years 9 months
|
|
Gastrointestinal disorders
Melaena
|
1.2%
2/169 • Number of events 2 • AEs were collected for 3 years 9 months
|
|
Gastrointestinal disorders
Mouth ulceration
|
1.2%
2/169 • Number of events 2 • AEs were collected for 3 years 9 months
|
|
Gastrointestinal disorders
Oral pain
|
1.2%
2/169 • Number of events 2 • AEs were collected for 3 years 9 months
|
|
Gastrointestinal disorders
Abdominal rigidity
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Gastrointestinal disorders
Angular cheilitis
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Gastrointestinal disorders
Autoimmune enteropathy
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Gastrointestinal disorders
Cheilitis
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Gastrointestinal disorders
Diverticulum
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Gastrointestinal disorders
Dysphagia
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Gastrointestinal disorders
Faeces soft
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Gastrointestinal disorders
Gastrointestinal sounds abnormal
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Gastrointestinal disorders
Gastrointestinal wall thickening
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Gastrointestinal disorders
Gingival pain
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Gastrointestinal disorders
Haematochezia
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Gastrointestinal disorders
Lip dry
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Gastrointestinal disorders
Odynophagia
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Gastrointestinal disorders
Oral discomfort
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Gastrointestinal disorders
Pancreatitis
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Gastrointestinal disorders
Proctalgia
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Gastrointestinal disorders
Rectal tenesmus
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Gastrointestinal disorders
Tongue ulceration
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Gastrointestinal disorders
Tooth disorder
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Infections and infestations
COVID-19
|
13.6%
23/169 • Number of events 23 • AEs were collected for 3 years 9 months
|
|
Infections and infestations
Urinary tract infection
|
5.9%
10/169 • Number of events 10 • AEs were collected for 3 years 9 months
|
|
Infections and infestations
Pneumonia
|
2.4%
4/169 • Number of events 4 • AEs were collected for 3 years 9 months
|
|
Infections and infestations
Upper respiratory tract infection
|
5.9%
10/169 • Number of events 10 • AEs were collected for 3 years 9 months
|
|
Infections and infestations
Herpes zoster
|
5.3%
9/169 • Number of events 9 • AEs were collected for 3 years 9 months
|
|
Infections and infestations
Cytomegalovirus infection
|
4.1%
7/169 • Number of events 7 • AEs were collected for 3 years 9 months
|
|
Infections and infestations
Asymptomatic COVID-19
|
3.6%
6/169 • Number of events 6 • AEs were collected for 3 years 9 months
|
|
Infections and infestations
Bronchitis
|
3.6%
6/169 • Number of events 6 • AEs were collected for 3 years 9 months
|
|
Infections and infestations
COVID-19 pneumonia
|
1.2%
2/169 • Number of events 2 • AEs were collected for 3 years 9 months
|
|
Infections and infestations
Cytomegalovirus infection reactivation
|
3.0%
5/169 • Number of events 5 • AEs were collected for 3 years 9 months
|
|
Infections and infestations
Herpes simplex
|
3.0%
5/169 • Number of events 5 • AEs were collected for 3 years 9 months
|
|
Infections and infestations
Sinusitis
|
3.0%
5/169 • Number of events 5 • AEs were collected for 3 years 9 months
|
|
Infections and infestations
Nasopharyngitis
|
2.4%
4/169 • Number of events 4 • AEs were collected for 3 years 9 months
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
1.8%
3/169 • Number of events 3 • AEs were collected for 3 years 9 months
|
|
Infections and infestations
Candida infection
|
1.8%
3/169 • Number of events 3 • AEs were collected for 3 years 9 months
|
|
Infections and infestations
Lower respiratory tract infection
|
1.2%
2/169 • Number of events 2 • AEs were collected for 3 years 9 months
|
|
Infections and infestations
Rhinitis
|
1.8%
3/169 • Number of events 3 • AEs were collected for 3 years 9 months
|
|
Infections and infestations
Diverticulitis
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Infections and infestations
Oral candidiasis
|
1.2%
2/169 • Number of events 2 • AEs were collected for 3 years 9 months
|
|
Infections and infestations
Pyelonephritis
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Infections and infestations
Bacterial diarrhoea
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Infections and infestations
Cellulitis
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Infections and infestations
Cellulitis of male external genital organ
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Infections and infestations
Conjunctivitis
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Infections and infestations
Conjunctivitis bacterial
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Infections and infestations
Coronavirus infection
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Infections and infestations
Cystitis
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Infections and infestations
Cytomegalovirus gastroenteritis
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Infections and infestations
Cytomegalovirus viraemia
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Infections and infestations
Escherichia sepsis
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Infections and infestations
Folliculitis
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Infections and infestations
Furuncle
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Infections and infestations
Gastroenteritis
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Infections and infestations
Gastrointestinal infection
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Infections and infestations
Influenza
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Infections and infestations
Lower respiratory tract infection bacterial
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Infections and infestations
Nail infection
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Infections and infestations
Oesophageal candidiasis
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Infections and infestations
Oral viral infection
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Infections and infestations
Pharyngitis
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Infections and infestations
Pneumonia klebsiella
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Infections and infestations
Rhinovirus infection
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Infections and infestations
Sinusitis bacterial
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Infections and infestations
Skin infection
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Infections and infestations
Vaginal infection
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Infections and infestations
Varicella
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Infections and infestations
Vestibular neuronitis
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
General disorders
Fatigue
|
17.8%
30/169 • Number of events 30 • AEs were collected for 3 years 9 months
|
|
General disorders
Pyrexia
|
15.4%
26/169 • Number of events 26 • AEs were collected for 3 years 9 months
|
|
General disorders
Asthenia
|
8.3%
14/169 • Number of events 14 • AEs were collected for 3 years 9 months
|
|
General disorders
Oedema peripheral
|
5.9%
10/169 • Number of events 10 • AEs were collected for 3 years 9 months
|
|
General disorders
Chest pain
|
2.4%
4/169 • Number of events 4 • AEs were collected for 3 years 9 months
|
|
General disorders
Mucosal inflammation
|
2.4%
4/169 • Number of events 4 • AEs were collected for 3 years 9 months
|
|
General disorders
Chills
|
1.8%
3/169 • Number of events 3 • AEs were collected for 3 years 9 months
|
|
General disorders
Influenza like illness
|
1.8%
3/169 • Number of events 3 • AEs were collected for 3 years 9 months
|
|
General disorders
Non-cardiac chest pain
|
1.8%
3/169 • Number of events 3 • AEs were collected for 3 years 9 months
|
|
General disorders
Chest discomfort
|
1.2%
2/169 • Number of events 2 • AEs were collected for 3 years 9 months
|
|
General disorders
Gait disturbance
|
1.2%
2/169 • Number of events 2 • AEs were collected for 3 years 9 months
|
|
General disorders
Inflammation
|
1.2%
2/169 • Number of events 2 • AEs were collected for 3 years 9 months
|
|
General disorders
Cyst
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
General disorders
Discomfort
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
General disorders
Drug intolerance
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
General disorders
Hyperthermia
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
General disorders
Injection site rash
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
General disorders
Localised oedema
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
General disorders
Malaise
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
General disorders
Oedema
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
General disorders
Pain
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
General disorders
Swelling face
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.4%
21/169 • Number of events 21 • AEs were collected for 3 years 9 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.9%
15/169 • Number of events 15 • AEs were collected for 3 years 9 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
7.7%
13/169 • Number of events 13 • AEs were collected for 3 years 9 months
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
3.0%
5/169 • Number of events 5 • AEs were collected for 3 years 9 months
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
3.0%
5/169 • Number of events 5 • AEs were collected for 3 years 9 months
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.4%
4/169 • Number of events 4 • AEs were collected for 3 years 9 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
1.8%
3/169 • Number of events 3 • AEs were collected for 3 years 9 months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.8%
3/169 • Number of events 3 • AEs were collected for 3 years 9 months
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
1.8%
3/169 • Number of events 3 • AEs were collected for 3 years 9 months
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
1.2%
2/169 • Number of events 2 • AEs were collected for 3 years 9 months
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
1.8%
3/169 • Number of events 3 • AEs were collected for 3 years 9 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.2%
2/169 • Number of events 2 • AEs were collected for 3 years 9 months
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
1.2%
2/169 • Number of events 2 • AEs were collected for 3 years 9 months
|
|
Skin and subcutaneous tissue disorders
Eczema
|
1.2%
2/169 • Number of events 2 • AEs were collected for 3 years 9 months
|
|
Skin and subcutaneous tissue disorders
Granuloma annulare
|
1.2%
2/169 • Number of events 2 • AEs were collected for 3 years 9 months
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
1.2%
2/169 • Number of events 2 • AEs were collected for 3 years 9 months
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis psoriasiform
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Skin and subcutaneous tissue disorders
Hand dermatitis
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Skin and subcutaneous tissue disorders
Perivascular dermatitis
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Skin and subcutaneous tissue disorders
Precancerous skin lesion
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Skin and subcutaneous tissue disorders
Skin depigmentation
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Investigations
Neutrophil count decreased
|
11.2%
19/169 • Number of events 19 • AEs were collected for 3 years 9 months
|
|
Investigations
Weight decreased
|
9.5%
16/169 • Number of events 16 • AEs were collected for 3 years 9 months
|
|
Investigations
ALT increased
|
8.3%
14/169 • Number of events 14 • AEs were collected for 3 years 9 months
|
|
Investigations
AST increased
|
7.7%
13/169 • Number of events 13 • AEs were collected for 3 years 9 months
|
|
Investigations
Blood creatinine increased
|
6.5%
11/169 • Number of events 11 • AEs were collected for 3 years 9 months
|
|
Investigations
Platelet count decreased
|
4.7%
8/169 • Number of events 8 • AEs were collected for 3 years 9 months
|
|
Investigations
Blood lactate dehydrogenase increased
|
4.7%
8/169 • Number of events 8 • AEs were collected for 3 years 9 months
|
|
Investigations
White blood cell count decreased
|
4.7%
8/169 • Number of events 8 • AEs were collected for 3 years 9 months
|
|
Investigations
Lymphocyte count decreased
|
3.6%
6/169 • Number of events 6 • AEs were collected for 3 years 9 months
|
|
Investigations
Blood alkaline phosphatase increased
|
2.4%
4/169 • Number of events 4 • AEs were collected for 3 years 9 months
|
|
Investigations
C-reactive protein increased
|
1.2%
2/169 • Number of events 2 • AEs were collected for 3 years 9 months
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.8%
3/169 • Number of events 3 • AEs were collected for 3 years 9 months
|
|
Investigations
Blood cholesterol increased
|
1.2%
2/169 • Number of events 2 • AEs were collected for 3 years 9 months
|
|
Investigations
Blood lactate dehydrogenase
|
1.2%
2/169 • Number of events 2 • AEs were collected for 3 years 9 months
|
|
Investigations
Cytomegalovirus test positive
|
1.2%
2/169 • Number of events 2 • AEs were collected for 3 years 9 months
|
|
Investigations
Lymphocyte count increased
|
1.2%
2/169 • Number of events 2 • AEs were collected for 3 years 9 months
|
|
Investigations
AST/ALT ratio abnormal
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Investigations
Aspartate aminotransferase
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Investigations
Blood bilirubin increased
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Investigations
Blood creatinine decreased
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Investigations
Blood immunoglobulin G decreased
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Investigations
Blood potassium decreased
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Investigations
Blood pressure increased
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Investigations
Blood urea increased
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Investigations
Body temperature increased
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Investigations
Electrocardiogram QT prolonged
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Investigations
International normalised ratio increased
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Investigations
Oxygen saturation decreased
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Investigations
Prothrombin time shortened
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Investigations
SARS-CoV-2 test positive
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Investigations
Transaminases increased
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Investigations
Troponin increased
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Investigations
Vitamin D decreased
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Investigations
White blood cell count increased
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
16.6%
28/169 • Number of events 28 • AEs were collected for 3 years 9 months
|
|
Blood and lymphatic system disorders
Anaemia
|
11.8%
20/169 • Number of events 20 • AEs were collected for 3 years 9 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
9.5%
16/169 • Number of events 16 • AEs were collected for 3 years 9 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.2%
2/169 • Number of events 2 • AEs were collected for 3 years 9 months
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.8%
3/169 • Number of events 3 • AEs were collected for 3 years 9 months
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
1.2%
2/169 • Number of events 2 • AEs were collected for 3 years 9 months
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Blood and lymphatic system disorders
Febrile bone marrow aplasia
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Blood and lymphatic system disorders
Increased tendency to bruise
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
13.6%
23/169 • Number of events 23 • AEs were collected for 3 years 9 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.5%
11/169 • Number of events 11 • AEs were collected for 3 years 9 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
3.6%
6/169 • Number of events 6 • AEs were collected for 3 years 9 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
4.1%
7/169 • Number of events 7 • AEs were collected for 3 years 9 months
|
|
Metabolism and nutrition disorders
Dehydration
|
3.0%
5/169 • Number of events 5 • AEs were collected for 3 years 9 months
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
3.0%
5/169 • Number of events 5 • AEs were collected for 3 years 9 months
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
2.4%
4/169 • Number of events 4 • AEs were collected for 3 years 9 months
|
|
Metabolism and nutrition disorders
Appetite disorder
|
1.2%
2/169 • Number of events 2 • AEs were collected for 3 years 9 months
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
1.2%
2/169 • Number of events 2 • AEs were collected for 3 years 9 months
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
1.2%
2/169 • Number of events 2 • AEs were collected for 3 years 9 months
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.2%
2/169 • Number of events 2 • AEs were collected for 3 years 9 months
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
1.2%
2/169 • Number of events 2 • AEs were collected for 3 years 9 months
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Metabolism and nutrition disorders
Overweight
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.2%
24/169 • Number of events 24 • AEs were collected for 3 years 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.9%
15/169 • Number of events 15 • AEs were collected for 3 years 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.6%
6/169 • Number of events 6 • AEs were collected for 3 years 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
3.6%
6/169 • Number of events 6 • AEs were collected for 3 years 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
3.6%
6/169 • Number of events 6 • AEs were collected for 3 years 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.4%
4/169 • Number of events 4 • AEs were collected for 3 years 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
2.4%
4/169 • Number of events 4 • AEs were collected for 3 years 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.2%
2/169 • Number of events 2 • AEs were collected for 3 years 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
1.8%
3/169 • Number of events 3 • AEs were collected for 3 years 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
1.2%
2/169 • Number of events 2 • AEs were collected for 3 years 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
1.2%
2/169 • Number of events 2 • AEs were collected for 3 years 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Catarrh
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Sputum discoloured
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Nervous system disorders
Headache
|
10.7%
18/169 • Number of events 18 • AEs were collected for 3 years 9 months
|
|
Nervous system disorders
Dizziness
|
7.1%
12/169 • Number of events 12 • AEs were collected for 3 years 9 months
|
|
Nervous system disorders
Paraesthesia
|
3.0%
5/169 • Number of events 5 • AEs were collected for 3 years 9 months
|
|
Nervous system disorders
Memory impairment
|
2.4%
4/169 • Number of events 4 • AEs were collected for 3 years 9 months
|
|
Nervous system disorders
Neuropathy peripheral
|
2.4%
4/169 • Number of events 4 • AEs were collected for 3 years 9 months
|
|
Nervous system disorders
Dysgeusia
|
1.8%
3/169 • Number of events 3 • AEs were collected for 3 years 9 months
|
|
Nervous system disorders
Hypoaesthesia
|
1.8%
3/169 • Number of events 3 • AEs were collected for 3 years 9 months
|
|
Nervous system disorders
Lethargy
|
1.8%
3/169 • Number of events 3 • AEs were collected for 3 years 9 months
|
|
Nervous system disorders
Balance disorder
|
1.2%
2/169 • Number of events 2 • AEs were collected for 3 years 9 months
|
|
Nervous system disorders
Sciatica
|
1.2%
2/169 • Number of events 2 • AEs were collected for 3 years 9 months
|
|
Nervous system disorders
Taste disorder
|
1.2%
2/169 • Number of events 2 • AEs were collected for 3 years 9 months
|
|
Nervous system disorders
Tremor
|
1.2%
2/169 • Number of events 2 • AEs were collected for 3 years 9 months
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Nervous system disorders
Central nervous system lesion
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Nervous system disorders
Cerebrovascular accident
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Nervous system disorders
Disturbance in attention
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Nervous system disorders
Monoparesis
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Nervous system disorders
Neuralgia
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Nervous system disorders
Syncope
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Nervous system disorders
Toxic encephalopathy
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.5%
16/169 • Number of events 16 • AEs were collected for 3 years 9 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.1%
12/169 • Number of events 12 • AEs were collected for 3 years 9 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.7%
8/169 • Number of events 8 • AEs were collected for 3 years 9 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.1%
7/169 • Number of events 7 • AEs were collected for 3 years 9 months
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
3.6%
6/169 • Number of events 6 • AEs were collected for 3 years 9 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.8%
3/169 • Number of events 3 • AEs were collected for 3 years 9 months
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
1.2%
2/169 • Number of events 2 • AEs were collected for 3 years 9 months
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
1.2%
2/169 • Number of events 2 • AEs were collected for 3 years 9 months
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Musculoskeletal and connective tissue disorders
Inguinal mass
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Musculoskeletal and connective tissue disorders
Neck mass
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Renal and urinary disorders
Acute kidney injury
|
1.8%
3/169 • Number of events 3 • AEs were collected for 3 years 9 months
|
|
Renal and urinary disorders
Dysuria
|
3.0%
5/169 • Number of events 5 • AEs were collected for 3 years 9 months
|
|
Renal and urinary disorders
Haematuria
|
3.0%
5/169 • Number of events 5 • AEs were collected for 3 years 9 months
|
|
Renal and urinary disorders
Pollakiuria
|
1.8%
3/169 • Number of events 3 • AEs were collected for 3 years 9 months
|
|
Renal and urinary disorders
Hydronephrosis
|
1.2%
2/169 • Number of events 2 • AEs were collected for 3 years 9 months
|
|
Renal and urinary disorders
Proteinuria
|
1.2%
2/169 • Number of events 2 • AEs were collected for 3 years 9 months
|
|
Renal and urinary disorders
Renal failure
|
1.2%
2/169 • Number of events 2 • AEs were collected for 3 years 9 months
|
|
Renal and urinary disorders
Renal impairment
|
1.2%
2/169 • Number of events 2 • AEs were collected for 3 years 9 months
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Renal and urinary disorders
Glycosuria
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Renal and urinary disorders
Incontinence
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Renal and urinary disorders
Nocturia
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Renal and urinary disorders
Oliguria
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Renal and urinary disorders
Urinary incontinence
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Renal and urinary disorders
Urinary retention
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Renal and urinary disorders
Urinary tract disorder
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Cardiac disorders
Tachycardia
|
2.4%
4/169 • Number of events 4 • AEs were collected for 3 years 9 months
|
|
Cardiac disorders
Atrial fibrillation
|
1.8%
3/169 • Number of events 3 • AEs were collected for 3 years 9 months
|
|
Cardiac disorders
Palpitations
|
1.8%
3/169 • Number of events 3 • AEs were collected for 3 years 9 months
|
|
Cardiac disorders
Ventricular extrasystoles
|
1.2%
2/169 • Number of events 2 • AEs were collected for 3 years 9 months
|
|
Cardiac disorders
Acute myocardial infarction
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Cardiac disorders
Aortic valve incompetence
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Cardiac disorders
Arrhythmia
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Cardiac disorders
Atrioventricular block complete
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Cardiac disorders
Bradycardia
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Cardiac disorders
Cardiomegaly
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Cardiac disorders
Hyperdynamic left ventricle
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Cardiac disorders
Hypertensive cardiomyopathy
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Cardiac disorders
Sinus bradycardia
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Cardiac disorders
Sinus tachycardia
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Psychiatric disorders
Insomnia
|
5.3%
9/169 • Number of events 9 • AEs were collected for 3 years 9 months
|
|
Psychiatric disorders
Depression
|
3.0%
5/169 • Number of events 5 • AEs were collected for 3 years 9 months
|
|
Psychiatric disorders
Anxiety
|
2.4%
4/169 • Number of events 4 • AEs were collected for 3 years 9 months
|
|
Psychiatric disorders
Affect lability
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Psychiatric disorders
Nightmare
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Injury, poisoning and procedural complications
Fall
|
2.4%
4/169 • Number of events 4 • AEs were collected for 3 years 9 months
|
|
Injury, poisoning and procedural complications
Contusion
|
1.2%
2/169 • Number of events 2 • AEs were collected for 3 years 9 months
|
|
Injury, poisoning and procedural complications
Joint injury
|
1.2%
2/169 • Number of events 2 • AEs were collected for 3 years 9 months
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Injury, poisoning and procedural complications
Wound
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Vascular disorders
Hypertension
|
4.1%
7/169 • Number of events 7 • AEs were collected for 3 years 9 months
|
|
Vascular disorders
Hypotension
|
1.8%
3/169 • Number of events 3 • AEs were collected for 3 years 9 months
|
|
Vascular disorders
Deep vein thrombosis
|
1.2%
2/169 • Number of events 2 • AEs were collected for 3 years 9 months
|
|
Vascular disorders
Raynaud's phenomenon
|
1.2%
2/169 • Number of events 2 • AEs were collected for 3 years 9 months
|
|
Vascular disorders
Hot flush
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Vascular disorders
Shock
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.2%
2/169 • Number of events 2 • AEs were collected for 3 years 9 months
|
|
Hepatobiliary disorders
Hepatotoxicity
|
1.2%
2/169 • Number of events 2 • AEs were collected for 3 years 9 months
|
|
Hepatobiliary disorders
Cholestasis
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Hepatobiliary disorders
Hepatocellular injury
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
1.2%
2/169 • Number of events 2 • AEs were collected for 3 years 9 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of skin
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm swelling
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the tongue
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour necrosis
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Ear and labyrinth disorders
Hypoacusis
|
1.2%
2/169 • Number of events 2 • AEs were collected for 3 years 9 months
|
|
Ear and labyrinth disorders
Vertigo
|
1.2%
2/169 • Number of events 2 • AEs were collected for 3 years 9 months
|
|
Ear and labyrinth disorders
Deafness neurosensory
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Ear and labyrinth disorders
Ear pruritus
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Ear and labyrinth disorders
Otolithiasis
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Ear and labyrinth disorders
Tinnitus
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Eye disorders
Ocular discomfort
|
1.2%
2/169 • Number of events 2 • AEs were collected for 3 years 9 months
|
|
Eye disorders
Blepharitis
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Eye disorders
Eye discharge
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Eye disorders
Eye haematoma
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Eye disorders
Eye haemorrhage
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Eye disorders
Periorbital oedema
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Eye disorders
Punctate keratitis
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Eye disorders
Uveitis
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Eye disorders
Visual acuity reduced
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Reproductive system and breast disorders
Breast pain
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Reproductive system and breast disorders
Oedema genital
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Reproductive system and breast disorders
Pelvic discomfort
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Reproductive system and breast disorders
Scrotal oedema
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Endocrine disorders
Hyperthyroidism
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Endocrine disorders
Hypothyroidism
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Immune system disorders
Allergy to arthropod sting
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Immune system disorders
Hypersensitivity
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Congenital, familial and genetic disorders
Ichthyosis
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
|
Product Issues
Device failure
|
0.59%
1/169 • Number of events 1 • AEs were collected for 3 years 9 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee This study was terminated early however, each PI has a CDA in place that restricts them from discussing any results of the clinical study at a scientific meeting or any other public or private forum or to publish in a scientific or academic journal the results of the clinical study without the approval of the Sponsor Company (MEI Pharma Inc.).
- Publication restrictions are in place
Restriction type: OTHER