Trial Outcomes & Findings for Efficacy/Safety of CPI-613 in Combination With HD Cyt. and Mito. vs HD Cyt. and Mito. in Older Patients With R/R AML (NCT NCT03504410)
NCT ID: NCT03504410
Last Updated: 2023-02-08
Results Overview
Complete disappearance of all clinical evidence of disease
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
200 participants
Primary outcome timeframe
12 months
Results posted on
2023-02-08
Participant Flow
Participant milestones
| Measure |
CPI-613 + HD Cytarabine and Mitoxantrone
CPI-613 at 2,000 mg/m2/day from day 1 to 5.
Cytarabine at 1gm/m2 (5 doses), every 12 hours starting day 3. Mitoxantrone at 6gm/m2 (3 doses), everyday following the 1st, 2nd and 5th doses of Cytarabine.
|
Control (HAM) and Control Sub-groups (MEC and FLAG)
Cytarabine at 1gm/m2 (5 doses), every 12 hours starting day 3. Mitoxantrone at 6gm/m2 (3 doses), everyday following the 1st, 3rd and 5th doses of Cytarabine.
Mitoxantrone, Etoposide and Cytarabine
Etoposide 80mg/m over 60 minutes as a central line IV infusion; 6 doses Day 1 though 6 Cytarabine 1000mg/m2 over 3 hours as a central line IV infusion: 6 doses, Day 1 through 6 Mitoxantrone 6 mg/m2 over 30 minutes as a central line IV infusion: 6 dose, Day 1 through 6
Fludarabine, Cytarabine and Filgrastim
Fludarabine 30mg/m2/day over 30 minutes as a central line IV infusion; 5 doses Day 1 though 5 Cytarabine 2g/m2 over 4 hours as a central line IV infusion: 4 hours after Fludarabine: 5 doses, Day 1 through 5 Filgrastim 5µg/kg/day by SQ or as per institutional guidelines starting from Day 1 through Day 5
|
|---|---|---|
|
Overall Study
STARTED
|
98
|
102
|
|
Overall Study
COMPLETED
|
11
|
11
|
|
Overall Study
NOT COMPLETED
|
87
|
91
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy/Safety of CPI-613 in Combination With HD Cyt. and Mito. vs HD Cyt. and Mito. in Older Patients With R/R AML
Baseline characteristics by cohort
| Measure |
CPI-613 + HD Cytarabine and Mitoxantrone
n=98 Participants
CPI-613 + High Dose Cytarabine and Mitoxantrone
CPI-613 at 2,000 mg/m2/day from day 1 to 5.
Cytarabine at 1gm/m2 (5 doses), every 12 hours starting day 3. Mitoxantrone at 6gm/m2 (3 doses), everyday following the 1st, 2nd and 5th doses of Cytarabine.
CPI-613 + High Dose Cytarabine and Mitoxantrone: CPI-613 + High Dose Cytarabine and Mitoxantrone CPI-613: 2000mg/m2, 5 doses once a day, days 1-5 Cytarabine 1gm/m2, 5 doses every 12hrs starting day 3 through day 5 Mitoxantrone 6mg/m2, 3 doses, once a day following the first, third and fifth doses of Cytarabine
|
Control (HAM) and Control Sub-groups (MEC and FLAG)
n=102 Participants
High Dose Cytarabine and Mitoxantrone
Cytarabine at 1gm/m2 (5 doses), every 12 hours starting day 3. Mitoxantrone at 6gm/m2 (3 doses), everyday following the 1st, 3rd and 5th doses of Cytarabine.
Mitoxantrone, Etoposide and Cytarabine
Etoposide 80mg/m over 60 minutes as a central line IV infusion; 6 doses Day 1 though 6 Cytarabine 1000mg/m2 over 3 hours as a central line IV infusion: 6 doses, Day 1 through 6 Mitoxantrone 6 mg/m2 over 30 minutes as a central line IV infusion: 6 dose, Day 1 through 6
Fludarabine, Cytarabine and Filgrastim
Fludarabine 30mg/m2/day over 30 minutes as a central line IV infusion; 5 doses Day 1 though 5 Cytarabine 2g/m2 over 4 hours as a central line IV infusion: 4 hours after Fludarabine: 5 doses, Day 1 through 5 Filgrastim 5µg/kg/day by SQ or as per institutional guidelines starting from Day 1 through Day 5
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
42 Participants
n=93 Participants
|
46 Participants
n=4 Participants
|
88 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
56 Participants
n=93 Participants
|
56 Participants
n=4 Participants
|
112 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=93 Participants
|
42 Participants
n=4 Participants
|
79 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
61 Participants
n=93 Participants
|
60 Participants
n=4 Participants
|
121 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
72 Participants
n=93 Participants
|
81 Participants
n=4 Participants
|
153 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
18 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
36 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Number of Participants with Complete Remission (CR)
Complete disappearance of all clinical evidence of disease
Outcome measures
| Measure |
CPI-613 + HD Cytarabine and Mitoxantrone
n=98 Participants
CPI-613 + High Dose Cytarabine and Mitoxantrone
CPI-613 at 2,000 mg/m2/day from day 1 to 5.
Cytarabine at 1gm/m2 (5 doses), every 12 hours starting day 3. Mitoxantrone at 6gm/m2 (3 doses), everyday following the 1st, 2nd and 5th doses of Cytarabine.
CPI-613 + High Dose Cytarabine and Mitoxantrone: CPI-613 + High Dose Cytarabine and Mitoxantrone CPI-613: 2000mg/m2, 5 doses once a day, days 1-5 Cytarabine 1gm/m2, 5 doses every 12hrs starting day 3 through day 5 Mitoxantrone 6mg/m2, 3 doses, once a day following the first, third and fifth doses of Cytarabine
|
Control (HAM) and Control Sub-groups (MEC and FLAG)
n=102 Participants
High Dose Cytarabine and Mitoxantrone
Cytarabine at 1gm/m2 (5 doses), every 12 hours starting day 3. Mitoxantrone at 6gm/m2 (3 doses), everyday following the 1st, 3rd and 5th doses of Cytarabine.
Mitoxantrone, Etoposide and Cytarabine
Etoposide 80mg/m over 60 minutes as a central line IV infusion; 6 doses Day 1 though 6 Cytarabine 1000mg/m2 over 3 hours as a central line IV infusion: 6 doses, Day 1 through 6 Mitoxantrone 6 mg/m2 over 30 minutes as a central line IV infusion: 6 dose, Day 1 through 6
Fludarabine, Cytarabine and Filgrastim
Fludarabine 30mg/m2/day over 30 minutes as a central line IV infusion; 5 doses Day 1 though 5 Cytarabine 2g/m2 over 4 hours as a central line IV infusion: 4 hours after Fludarabine: 5 doses, Day 1 through 5 Filgrastim 5µg/kg/day by SQ or as per institutional guidelines starting from Day 1 through Day 5
|
|---|---|---|
|
Complete Remission (CR)
|
20 Participants
|
22 Participants
|
Adverse Events
CPI-613 + HD Cytarabine and Mitoxantrone
Serious events: 36 serious events
Other events: 93 other events
Deaths: 52 deaths
Control (HAM) and Control Sub-groups (MEC and FLAG)
Serious events: 34 serious events
Other events: 94 other events
Deaths: 55 deaths
Serious adverse events
| Measure |
CPI-613 + HD Cytarabine and Mitoxantrone
n=96 participants at risk
CPI-613 + High Dose Cytarabine and Mitoxantrone
CPI-613 at 2,000 mg/m2/day from day 1 to 5.
Cytarabine at 1gm/m2 (5 doses), every 12 hours starting day 3. Mitoxantrone at 6gm/m2 (3 doses), everyday following the 1st, 2nd and 5th doses of Cytarabine.
|
Control (HAM) and Control Sub-groups (MEC and FLAG)
n=97 participants at risk
High Dose Cytarabine and Mitoxantrone
Cytarabine at 1gm/m2 (5 doses), every 12 hours starting day 3. Mitoxantrone at 6gm/m2 (3 doses), everyday following the 1st, 3rd and 5th doses of Cytarabine.
Mitoxantrone, Etoposide and Cytarabine
Etoposide 80mg/m over 60 minutes as a central line IV infusion; 6 doses Day 1 though 6 Cytarabine 1000mg/m2 over 3 hours as a central line IV infusion: 6 doses, Day 1 through 6 Mitoxantrone 6 mg/m2 over 30 minutes as a central line IV infusion: 6 dose, Day 1 through 6
Fludarabine, Cytarabine and Filgrastim
Fludarabine 30mg/m2/day over 30 minutes as a central line IV infusion; 5 doses Day 1 though 5 Cytarabine 2g/m2 over 4 hours as a central line IV infusion: 4 hours after Fludarabine: 5 doses, Day 1 through 5 Filgrastim 5µg/kg/day by SQ or as per institutional guidelines starting from Day 1 through Day 5
|
|---|---|---|
|
Blood and lymphatic system disorders
disseminated intravascular coagulation
|
1.0%
1/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
2.1%
2/96 • 38 months
|
6.2%
6/97 • 38 months
|
|
Blood and lymphatic system disorders
Hemolysis
|
2.1%
2/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Blood and lymphatic system disorders
Leukostasis syndrome
|
0.00%
0/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Cardiac disorders
Atrial Fibrillation
|
3.1%
3/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Cardiac disorders
Atrial Flutter
|
0.00%
0/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Cardiac disorders
Cardiac arrest
|
1.0%
1/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Cardiac disorders
cardiac failure acute
|
1.0%
1/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Eye disorders
Photophobia
|
0.00%
0/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Gastrointestinal disorders
Anal fistula
|
1.0%
1/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Gastrointestinal disorders
Enterocolitis
|
1.0%
1/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Gastrointestinal disorders
Ileus
|
1.0%
1/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Gastrointestinal disorders
small intestinal obstruction
|
0.00%
0/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Infections and infestations
Achromobacter infection
|
0.00%
0/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Infections and infestations
Anal Abscess
|
1.0%
1/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Infections and infestations
Bacillus bacteraemia
|
1.0%
1/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/96 • 38 months
|
2.1%
2/97 • 38 months
|
|
Infections and infestations
Covid-19
|
1.0%
1/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Infections and infestations
Candida infection
|
1.0%
1/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Infections and infestations
Cellulitis
|
1.0%
1/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Infections and infestations
Device related infection
|
0.00%
0/96 • 38 months
|
2.1%
2/97 • 38 months
|
|
Infections and infestations
Encephalitis
|
1.0%
1/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Infections and infestations
Enterococcal infection
|
0.00%
0/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Infections and infestations
Fungal oesophagitis
|
0.00%
0/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Infections and infestations
Klebsiella sepsis
|
1.0%
1/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Infections and infestations
Neutropenic sepsis
|
1.0%
1/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Infections and infestations
Pneumococcal infection
|
0.00%
0/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Infections and infestations
Pneumonia
|
4.2%
4/96 • 38 months
|
5.2%
5/97 • 38 months
|
|
Infections and infestations
Pseudomonal sepsis
|
1.0%
1/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Infections and infestations
Scrotal infection
|
0.00%
0/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Infections and infestations
Sepsis
|
6.2%
6/96 • 38 months
|
5.2%
5/97 • 38 months
|
|
Infections and infestations
Septic Shock
|
3.1%
3/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Infections and infestations
Stenotrophomonas infection
|
1.0%
1/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Injury, poisoning and procedural complications
Fall
|
1.0%
1/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Metabolism and nutrition disorders
Fluid Overload
|
1.0%
1/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
1.0%
1/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Nervous system disorders
Aphasia
|
1.0%
1/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Nervous system disorders
Cerebrovascular accident
|
1.0%
1/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Product Issues
device occlusion
|
0.00%
0/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Renal and urinary disorders
Acute Kidney Injury
|
2.1%
2/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
2.1%
2/96 • 38 months
|
2.1%
2/97 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
1.0%
1/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Vascular disorders
Hypotension
|
1.0%
1/96 • 38 months
|
0.00%
0/97 • 38 months
|
Other adverse events
| Measure |
CPI-613 + HD Cytarabine and Mitoxantrone
n=96 participants at risk
CPI-613 + High Dose Cytarabine and Mitoxantrone
CPI-613 at 2,000 mg/m2/day from day 1 to 5.
Cytarabine at 1gm/m2 (5 doses), every 12 hours starting day 3. Mitoxantrone at 6gm/m2 (3 doses), everyday following the 1st, 2nd and 5th doses of Cytarabine.
|
Control (HAM) and Control Sub-groups (MEC and FLAG)
n=97 participants at risk
High Dose Cytarabine and Mitoxantrone
Cytarabine at 1gm/m2 (5 doses), every 12 hours starting day 3. Mitoxantrone at 6gm/m2 (3 doses), everyday following the 1st, 3rd and 5th doses of Cytarabine.
Mitoxantrone, Etoposide and Cytarabine
Etoposide 80mg/m over 60 minutes as a central line IV infusion; 6 doses Day 1 though 6 Cytarabine 1000mg/m2 over 3 hours as a central line IV infusion: 6 doses, Day 1 through 6 Mitoxantrone 6 mg/m2 over 30 minutes as a central line IV infusion: 6 dose, Day 1 through 6
Fludarabine, Cytarabine and Filgrastim
Fludarabine 30mg/m2/day over 30 minutes as a central line IV infusion; 5 doses Day 1 though 5 Cytarabine 2g/m2 over 4 hours as a central line IV infusion: 4 hours after Fludarabine: 5 doses, Day 1 through 5 Filgrastim 5µg/kg/day by SQ or as per institutional guidelines starting from Day 1 through Day 5
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Rash morbilliform
|
1.0%
1/96 • 38 months
|
9.3%
9/97 • 38 months
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
1.0%
1/96 • 38 months
|
2.1%
2/97 • 38 months
|
|
Infections and infestations
Rash pustular
|
2.1%
2/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory depression
|
1.0%
1/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
1.0%
1/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/96 • 38 months
|
2.1%
2/97 • 38 months
|
|
Infections and infestations
Root canal infection
|
1.0%
1/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Infections and infestations
Scrotal infection
|
0.00%
0/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Reproductive system and breast disorders
Scrotal pain
|
0.00%
0/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Infections and infestations
Sepsis
|
10.4%
10/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Infections and infestations
Septic shock
|
5.2%
5/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Infections and infestations
Abdominal abscess
|
1.0%
1/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Gastrointestinal disorders
Abdominal distension
|
3.1%
3/96 • 38 months
|
3.1%
3/97 • 38 months
|
|
Gastrointestinal disorders
Abdominal pain
|
5.2%
5/96 • 38 months
|
7.2%
7/97 • 38 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.1%
3/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Metabolism and nutrition disorders
Abnormal loss of weight
|
1.0%
1/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Infections and infestations
Abscess limb
|
1.0%
1/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Infections and infestations
Achromobacter infection
|
0.00%
0/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Investigations
Activated partial thromboplastin time prolonged
|
1.0%
1/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Renal and urinary disorders
Acute kidney injury
|
8.3%
8/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
3.1%
3/96 • 38 months
|
2.1%
2/97 • 38 months
|
|
Nervous system disorders
Ageusia
|
0.00%
0/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Psychiatric disorders
Agitation
|
0.00%
0/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Investigations
Alanine aminotransferase increased
|
9.4%
9/96 • 38 months
|
14.4%
14/97 • 38 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Infections and infestations
Anal abscess
|
1.0%
1/96 • 38 months
|
36.1%
35/97 • 38 months
|
|
Gastrointestinal disorders
Anal fistula
|
2.1%
2/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Gastrointestinal disorders
Anal incontinence
|
1.0%
1/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Gastrointestinal disorders
Anal inflammation
|
1.0%
1/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Gastrointestinal disorders
Anorectal discomfort
|
1.0%
1/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Psychiatric disorders
Anxiety
|
2.1%
2/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Nervous system disorders
Aphasia
|
1.0%
1/96 • 38 months
|
2.1%
2/97 • 38 months
|
|
Cardiac disorders
Arrhythmia
|
1.0%
1/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.2%
5/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Investigations
Aspartate aminotransferase increased
|
8.3%
8/96 • 38 months
|
6.2%
6/97 • 38 months
|
|
Infections and infestations
Aspergilloma
|
1.0%
1/96 • 38 months
|
9.3%
9/97 • 38 months
|
|
Infections and infestations
Aspergillus infection
|
1.0%
1/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
General disorders
Asthenia
|
3.1%
3/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/96 • 38 months
|
6.2%
6/97 • 38 months
|
|
Cardiac disorders
Atrial fibrillation
|
7.3%
7/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Cardiac disorders
Atrial flutter
|
1.0%
1/96 • 38 months
|
4.1%
4/97 • 38 months
|
|
Cardiac disorders
Atrioventricular block first degree
|
1.0%
1/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Infections and infestations
Bacillus bacteraemia
|
1.0%
1/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Infections and infestations
Bacillus infection
|
1.0%
1/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.2%
6/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Infections and infestations
Bacteraemia
|
3.1%
3/96 • 38 months
|
8.2%
8/97 • 38 months
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
1.0%
1/96 • 38 months
|
7.2%
7/97 • 38 months
|
|
Investigations
Blood alkaline phosphatase increased
|
4.2%
4/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Investigations
Blood bilirubin increased
|
10.4%
10/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Investigations
Blood creatinine increased
|
2.1%
2/96 • 38 months
|
5.2%
5/97 • 38 months
|
|
Investigations
Blood fibrinogen decreased
|
0.00%
0/96 • 38 months
|
7.2%
7/97 • 38 months
|
|
Investigations
Blood fibrinogen increased
|
1.0%
1/96 • 38 months
|
6.2%
6/97 • 38 months
|
|
Investigations
Blood folate decreased
|
0.00%
0/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Investigations
Blood lactate dehydrogenase increased
|
2.1%
2/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Investigations
Blood phosphorus increased
|
1.0%
1/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Investigations
Blood uric acid increased
|
0.00%
0/96 • 38 months
|
2.1%
2/97 • 38 months
|
|
Investigations
Body temperature increased
|
0.00%
0/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Infections and infestations
Bone abscess
|
1.0%
1/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
3.1%
3/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Cardiac disorders
Bradycardia
|
4.2%
4/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Investigations
Breath sounds abnormal
|
0.00%
0/96 • 38 months
|
2.1%
2/97 • 38 months
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
2.1%
2/96 • 38 months
|
2.1%
2/97 • 38 months
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.00%
0/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Investigations
C-reactive protein increased
|
5.2%
5/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Infections and infestations
Candida infection
|
3.1%
3/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Cardiac disorders
Cardiac arrest
|
1.0%
1/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Cardiac disorders
Cardiac failure
|
2.1%
2/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Cardiac disorders
Cardiac failure acute
|
1.0%
1/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Surgical and medical procedures
Catheter management
|
0.00%
0/96 • 38 months
|
3.1%
3/97 • 38 months
|
|
General disorders
Catheter site erythema
|
1.0%
1/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
General disorders
Catheter site haemorrhage
|
0.00%
0/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
General disorders
Catheter site induration
|
1.0%
1/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
General disorders
Catheter site pain
|
1.0%
1/96 • 38 months
|
2.1%
2/97 • 38 months
|
|
Infections and infestations
Cellulitis
|
5.2%
5/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Nervous system disorders
Cerebral atrophy
|
0.00%
0/96 • 38 months
|
2.1%
2/97 • 38 months
|
|
Nervous system disorders
Cerebral haemorrhage
|
1.0%
1/96 • 38 months
|
4.1%
4/97 • 38 months
|
|
Nervous system disorders
Cerebrovascular accident
|
1.0%
1/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Gastrointestinal disorders
Cheilitis
|
1.0%
1/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
General disorders
Chills
|
5.2%
5/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Hepatobiliary disorders
Cholestasis
|
1.0%
1/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Renal and urinary disorders
Chromaturia
|
1.0%
1/96 • 38 months
|
10.3%
10/97 • 38 months
|
|
Vascular disorders
Circulatory collapse
|
1.0%
1/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Infections and infestations
Citrobacter infection
|
0.00%
0/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Infections and infestations
Clostridium difficile colitis
|
4.2%
4/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Infections and infestations
Clostridium difficile infection
|
4.2%
4/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
1.0%
1/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Gastrointestinal disorders
Colitis
|
1.0%
1/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Psychiatric disorders
Confusional state
|
6.2%
6/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/96 • 38 months
|
2.1%
2/97 • 38 months
|
|
Gastrointestinal disorders
Constipation
|
21.9%
21/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Injury, poisoning and procedural complications
Contusion
|
2.1%
2/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.4%
9/96 • 38 months
|
20.6%
20/97 • 38 months
|
|
Infections and infestations
COVID-19
|
1.0%
1/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/96 • 38 months
|
9.3%
9/97 • 38 months
|
|
Investigations
Creatinine renal clearance decreased
|
1.0%
1/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
12.5%
12/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Vascular disorders
Deep vein thrombosis
|
1.0%
1/96 • 38 months
|
12.4%
12/97 • 38 months
|
|
Metabolism and nutrition disorders
Dehydration
|
1.0%
1/96 • 38 months
|
2.1%
2/97 • 38 months
|
|
Psychiatric disorders
Delirium
|
1.0%
1/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Nervous system disorders
Depressed level of consciousness
|
1.0%
1/96 • 38 months
|
2.1%
2/97 • 38 months
|
|
Psychiatric disorders
Depression
|
2.1%
2/96 • 38 months
|
3.1%
3/97 • 38 months
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
1.0%
1/96 • 38 months
|
2.1%
2/97 • 38 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis psoriasiform
|
0.00%
0/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Infections and infestations
Device related infection
|
3.1%
3/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
General disorders
Device related thrombosis
|
1.0%
1/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
1.0%
1/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Gastrointestinal disorders
Diarrhoea
|
44.8%
43/96 • 38 months
|
4.1%
4/97 • 38 months
|
|
Psychiatric disorders
Disorientation
|
1.0%
1/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
1.0%
1/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Nervous system disorders
Dizziness
|
6.2%
6/96 • 38 months
|
22.7%
22/97 • 38 months
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
1.0%
1/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Immune system disorders
Drug hypersensitivity
|
1.0%
1/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Eye disorders
Dry eye
|
1.0%
1/96 • 38 months
|
8.2%
8/97 • 38 months
|
|
Gastrointestinal disorders
Dry mouth
|
3.1%
3/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
4.2%
4/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Nervous system disorders
Dysgeusia
|
3.1%
3/96 • 38 months
|
2.1%
2/97 • 38 months
|
|
Nervous system disorders
Dyskinesia
|
0.00%
0/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Nervous system disorders
Dysmetria
|
0.00%
0/96 • 38 months
|
2.1%
2/97 • 38 months
|
|
Gastrointestinal disorders
Dyspepsia
|
4.2%
4/96 • 38 months
|
3.1%
3/97 • 38 months
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.3%
8/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/96 • 38 months
|
4.1%
4/97 • 38 months
|
|
Renal and urinary disorders
Dysuria
|
3.1%
3/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
1.0%
1/96 • 38 months
|
12.4%
12/97 • 38 months
|
|
Infections and infestations
Ecthyma
|
1.0%
1/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Investigations
Ejection fraction decreased
|
3.1%
3/96 • 38 months
|
3.1%
3/97 • 38 months
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Investigations
Electrocardiogram QT prolonged
|
1.0%
1/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Infections and infestations
Encephalitis
|
1.0%
1/96 • 38 months
|
2.1%
2/97 • 38 months
|
|
Infections and infestations
Endocarditis
|
1.0%
1/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Infections and infestations
Enterococcal infection
|
1.0%
1/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Gastrointestinal disorders
Enterocolitis
|
1.0%
1/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Infections and infestations
Enterocolitis infectious
|
1.0%
1/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Gastrointestinal disorders
Epigastric discomfort
|
1.0%
1/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.3%
8/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Infections and infestations
Escherichia bacteraemia
|
1.0%
1/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Eye disorders
Extraocular muscle paresis
|
0.00%
0/96 • 38 months
|
12.4%
12/97 • 38 months
|
|
Eye disorders
Eye haemorrhage
|
0.00%
0/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Eye disorders
Eye inflammation
|
1.0%
1/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Eye disorders
Eye pain
|
1.0%
1/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Eye disorders
Eye pruritus
|
1.0%
1/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Eye disorders
Eye swelling
|
1.0%
1/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
General disorders
Face oedema
|
1.0%
1/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Injury, poisoning and procedural complications
Fall
|
4.2%
4/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
General disorders
Fatigue
|
15.6%
15/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
36.5%
35/96 • 38 months
|
2.1%
2/97 • 38 months
|
|
Investigations
Fibrin D dimer increased
|
2.1%
2/96 • 38 months
|
5.2%
5/97 • 38 months
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
4.2%
4/96 • 38 months
|
13.4%
13/97 • 38 months
|
|
Gastrointestinal disorders
Flatulence
|
3.1%
3/96 • 38 months
|
33.0%
32/97 • 38 months
|
|
Metabolism and nutrition disorders
Fluid overload
|
4.2%
4/96 • 38 months
|
3.1%
3/97 • 38 months
|
|
Metabolism and nutrition disorders
Fluid retention
|
1.0%
1/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Vascular disorders
Flushing
|
0.00%
0/96 • 38 months
|
5.2%
5/97 • 38 months
|
|
Infections and infestations
Folliculitis
|
1.0%
1/96 • 38 months
|
6.2%
6/97 • 38 months
|
|
Infections and infestations
Fungal oesophagitis
|
0.00%
0/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
General disorders
Gait disturbance
|
0.00%
0/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.0%
1/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.0%
1/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
General disorders
Generalised oedema
|
2.1%
2/96 • 38 months
|
2.1%
2/97 • 38 months
|
|
Gastrointestinal disorders
Gingival bleeding
|
1.0%
1/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Gastrointestinal disorders
Gingival erythema
|
0.00%
0/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Gastrointestinal disorders
Gingival pain
|
1.0%
1/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Infections and infestations
Gingivitis
|
0.00%
0/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Investigations
Glomerular filtration rate decreased
|
0.00%
0/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Immune system disorders
Graft versus host disease in skin
|
0.00%
0/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.00%
0/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
1.0%
1/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Vascular disorders
Haematoma
|
1.0%
1/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Renal and urinary disorders
Haematuria
|
6.2%
6/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Blood and lymphatic system disorders
Haemolysis
|
2.1%
2/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.0%
1/96 • 38 months
|
2.1%
2/97 • 38 months
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
1.0%
1/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Gastrointestinal disorders
Haemorrhoids
|
5.2%
5/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Psychiatric disorders
Hallucination
|
2.1%
2/96 • 38 months
|
2.1%
2/97 • 38 months
|
|
Psychiatric disorders
Hallucination, visual
|
0.00%
0/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Injury, poisoning and procedural complications
Head injury
|
1.0%
1/96 • 38 months
|
3.1%
3/97 • 38 months
|
|
Nervous system disorders
Headache
|
19.8%
19/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Investigations
Heart rate increased
|
0.00%
0/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Investigations
Heart rate irregular
|
0.00%
0/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Nervous system disorders
Hemiparesis
|
1.0%
1/96 • 38 months
|
23.7%
23/97 • 38 months
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.00%
0/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Infections and infestations
Hepatosplenic candidiasis
|
0.00%
0/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Infections and infestations
Herpes simplex reactivation
|
1.0%
1/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Infections and infestations
Herpes zoster
|
1.0%
1/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
4.2%
4/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
1.0%
1/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
12.5%
12/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.1%
2/96 • 38 months
|
4.1%
4/97 • 38 months
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
3.1%
3/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Nervous system disorders
Hyperkinesia
|
0.00%
0/96 • 38 months
|
10.3%
10/97 • 38 months
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
2.1%
2/96 • 38 months
|
3.1%
3/97 • 38 months
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
1.0%
1/96 • 38 months
|
4.1%
4/97 • 38 months
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
4.2%
4/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Immune system disorders
Hypersensitivity
|
1.0%
1/96 • 38 months
|
2.1%
2/97 • 38 months
|
|
Vascular disorders
Hypertension
|
5.2%
5/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Vascular disorders
Hypertensive crisis
|
1.0%
1/96 • 38 months
|
8.2%
8/97 • 38 months
|
|
General disorders
Hyperthermia
|
1.0%
1/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/96 • 38 months
|
10.3%
10/97 • 38 months
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
2.1%
2/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
11.5%
11/96 • 38 months
|
2.1%
2/97 • 38 months
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
16.7%
16/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.0%
1/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
29.2%
28/96 • 38 months
|
14.4%
14/97 • 38 months
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
14.6%
14/96 • 38 months
|
16.5%
16/97 • 38 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
9.4%
9/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.00%
0/96 • 38 months
|
37.1%
36/97 • 38 months
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
15.6%
15/96 • 38 months
|
15.5%
15/97 • 38 months
|
|
Vascular disorders
Hypotension
|
10.4%
10/96 • 38 months
|
4.1%
4/97 • 38 months
|
|
General disorders
Hypothermia
|
1.0%
1/96 • 38 months
|
2.1%
2/97 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.2%
6/96 • 38 months
|
14.4%
14/97 • 38 months
|
|
Gastrointestinal disorders
Ileus
|
1.0%
1/96 • 38 months
|
14.4%
14/97 • 38 months
|
|
Infections and infestations
Infection
|
3.1%
3/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
General disorders
Inflammation
|
0.00%
0/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
General disorders
Influenza like illness
|
0.00%
0/96 • 38 months
|
4.1%
4/97 • 38 months
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
1.0%
1/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
General disorders
Injection site reaction
|
1.0%
1/96 • 38 months
|
2.1%
2/97 • 38 months
|
|
Psychiatric disorders
Insomnia
|
10.4%
10/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Reproductive system and breast disorders
Intermenstrual bleeding
|
0.00%
0/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Investigations
International normalised ratio increased
|
1.0%
1/96 • 38 months
|
2.1%
2/97 • 38 months
|
|
Injury, poisoning and procedural complications
Joint injury
|
1.0%
1/96 • 38 months
|
2.1%
2/97 • 38 months
|
|
Vascular disorders
Jugular vein thrombosis
|
1.0%
1/96 • 38 months
|
8.2%
8/97 • 38 months
|
|
Infections and infestations
Klebsiella bacteraemia
|
2.1%
2/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Infections and infestations
Klebsiella sepsis
|
1.0%
1/96 • 38 months
|
2.1%
2/97 • 38 months
|
|
Infections and infestations
Leptotrichia infection
|
1.0%
1/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Nervous system disorders
Lethargy
|
0.00%
0/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Infections and infestations
Leuconostoc infection
|
1.0%
1/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Blood and lymphatic system disorders
Leukopenia
|
4.2%
4/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Blood and lymphatic system disorders
Leukostasis syndrome
|
0.00%
0/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Gastrointestinal disorders
Lip pain
|
1.0%
1/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Gastrointestinal disorders
Lip swelling
|
1.0%
1/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Gastrointestinal disorders
Lip ulceration
|
1.0%
1/96 • 38 months
|
4.1%
4/97 • 38 months
|
|
General disorders
Localised oedema
|
0.00%
0/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Lung opacity
|
0.00%
0/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Investigations
Lymphocyte count decreased
|
12.5%
12/96 • 38 months
|
3.1%
3/97 • 38 months
|
|
Blood and lymphatic system disorders
Lymphopenia
|
1.0%
1/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Skin and subcutaneous tissue disorders
Macule
|
1.0%
1/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
General disorders
Malaise
|
0.00%
0/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Metabolism and nutrition disorders
Malnutrition
|
2.1%
2/96 • 38 months
|
11.3%
11/97 • 38 months
|
|
General disorders
Medical device site pain
|
2.1%
2/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
General disorders
Medical device site pruritus
|
1.0%
1/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Gastrointestinal disorders
Mesenteric panniculitis
|
1.0%
1/96 • 38 months
|
2.1%
2/97 • 38 months
|
|
Renal and urinary disorders
Micturition urgency
|
1.0%
1/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Infections and infestations
Moraxella infection
|
0.00%
0/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Infections and infestations
Morganella infection
|
0.00%
0/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Gastrointestinal disorders
Mouth ulceration
|
3.1%
3/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.1%
2/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
3.1%
3/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
1.0%
1/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/96 • 38 months
|
3.1%
3/97 • 38 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.1%
3/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal cavity mass
|
0.00%
0/96 • 38 months
|
3.1%
3/97 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
0.00%
0/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal disorder
|
1.0%
1/96 • 38 months
|
2.1%
2/97 • 38 months
|
|
Infections and infestations
Nasal herpes
|
0.00%
0/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Gastrointestinal disorders
Nausea
|
32.3%
31/96 • 38 months
|
4.1%
4/97 • 38 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Nervous system disorders
Neuralgia
|
1.0%
1/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Nervous system disorders
Neuropathy peripheral
|
2.1%
2/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
7.3%
7/96 • 38 months
|
25.8%
25/97 • 38 months
|
|
Gastrointestinal disorders
Neutropenic colitis
|
1.0%
1/96 • 38 months
|
2.1%
2/97 • 38 months
|
|
Infections and infestations
Neutropenic sepsis
|
1.0%
1/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Investigations
Neutrophil count decreased
|
12.5%
12/96 • 38 months
|
2.1%
2/97 • 38 months
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
1.0%
1/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
General disorders
Non-cardiac chest pain
|
1.0%
1/96 • 38 months
|
2.1%
2/97 • 38 months
|
|
Eye disorders
Ocular discomfort
|
1.0%
1/96 • 38 months
|
15.5%
15/97 • 38 months
|
|
Eye disorders
Ocular hyperaemia
|
1.0%
1/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
General disorders
Oedema peripheral
|
19.8%
19/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Infections and infestations
Oral candidiasis
|
1.0%
1/96 • 38 months
|
3.1%
3/97 • 38 months
|
|
Gastrointestinal disorders
Oral dysaesthesia
|
0.00%
0/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Infections and infestations
Oral herpes
|
1.0%
1/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Infections and infestations
Oral infection
|
2.1%
2/96 • 38 months
|
20.6%
20/97 • 38 months
|
|
Gastrointestinal disorders
Oral pain
|
3.1%
3/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.1%
2/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal plaque
|
1.0%
1/96 • 38 months
|
5.2%
5/97 • 38 months
|
|
Vascular disorders
Orthostatic hypotension
|
2.1%
2/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
General disorders
Pain
|
2.1%
2/96 • 38 months
|
4.1%
4/97 • 38 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.1%
3/96 • 38 months
|
3.1%
3/97 • 38 months
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Blood and lymphatic system disorders
Pancytopenia
|
3.1%
3/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Nervous system disorders
Paraesthesia
|
1.0%
1/96 • 38 months
|
4.1%
4/97 • 38 months
|
|
Infections and infestations
Pathogen resistance
|
0.00%
0/96 • 38 months
|
5.2%
5/97 • 38 months
|
|
Cardiac disorders
Pericardial effusion
|
2.1%
2/96 • 38 months
|
2.1%
2/97 • 38 months
|
|
General disorders
Peripheral swelling
|
0.00%
0/96 • 38 months
|
2.1%
2/97 • 38 months
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
2.1%
2/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal oedema
|
0.00%
0/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Vascular disorders
Phlebitis
|
1.0%
1/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Eye disorders
Photophobia
|
0.00%
0/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Investigations
Platelet count decreased
|
19.8%
19/96 • 38 months
|
7.2%
7/97 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.2%
6/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
2.1%
2/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Infections and infestations
Pneumococcal infection
|
0.00%
0/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Infections and infestations
Pneumonia
|
8.3%
8/96 • 38 months
|
20.6%
20/97 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
1.0%
1/96 • 38 months
|
3.1%
3/97 • 38 months
|
|
Infections and infestations
Pneumonia fungal
|
2.1%
2/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.0%
1/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Renal and urinary disorders
Pollakiuria
|
2.1%
2/96 • 38 months
|
10.3%
10/97 • 38 months
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
1.0%
1/96 • 38 months
|
5.2%
5/97 • 38 months
|
|
Injury, poisoning and procedural complications
Post procedural swelling
|
0.00%
0/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Nervous system disorders
Presyncope
|
0.00%
0/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Injury, poisoning and procedural complications
Procedural pain
|
1.0%
1/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Gastrointestinal disorders
Proctalgia
|
2.1%
2/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
2.1%
2/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Surgical and medical procedures
Prophylaxis of nausea and vomiting
|
1.0%
1/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Investigations
Prothrombin time prolonged
|
0.00%
0/96 • 38 months
|
2.1%
2/97 • 38 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.3%
7/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Infections and infestations
Pseudomonal bacteraemia
|
2.1%
2/96 • 38 months
|
4.1%
4/97 • 38 months
|
|
Infections and infestations
Pseudomonal sepsis
|
1.0%
1/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Infections and infestations
Pseudomonal skin infection
|
0.00%
0/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Nervous system disorders
Psychogenic seizure
|
0.00%
0/96 • 38 months
|
4.1%
4/97 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary cavitation
|
1.0%
1/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
3.1%
3/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
4.2%
4/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Investigations
Pulse abnormal
|
1.0%
1/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
General disorders
Pyrexia
|
22.9%
22/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.2%
6/96 • 38 months
|
4.1%
4/97 • 38 months
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
1.0%
1/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
1.0%
1/96 • 38 months
|
22.7%
22/97 • 38 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
3.1%
3/96 • 38 months
|
4.1%
4/97 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
1.0%
1/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Cardiac disorders
Sinus tachycardia
|
3.1%
3/96 • 38 months
|
10.3%
10/97 • 38 months
|
|
Infections and infestations
Sinusitis
|
0.00%
0/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
1.0%
1/96 • 38 months
|
2.1%
2/97 • 38 months
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
1.0%
1/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Infections and infestations
Skin infection
|
1.0%
1/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Injury, poisoning and procedural complications
Skin laceration
|
1.0%
1/96 • 38 months
|
2.1%
2/97 • 38 months
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
1.0%
1/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Injury, poisoning and procedural complications
Skin wound
|
0.00%
0/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
1.0%
1/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Psychiatric disorders
Sleep disorder
|
2.1%
2/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
1.0%
1/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Nervous system disorders
Somnolence
|
0.00%
0/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Blood and lymphatic system disorders
Splenomegaly
|
1.0%
1/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Sputum retention
|
0.00%
0/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Infections and infestations
Staphylococcal bacteraemia
|
3.1%
3/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Infections and infestations
Staphylococcal infection
|
1.0%
1/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Infections and infestations
Stenotrophomonas infection
|
1.0%
1/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Infections and infestations
Stenotrophomonas sepsis
|
1.0%
1/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Gastrointestinal disorders
Stomatitis
|
10.4%
10/96 • 38 months
|
2.1%
2/97 • 38 months
|
|
Infections and infestations
Stomatococcal infection
|
1.0%
1/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Infections and infestations
Streptococcal bacteraemia
|
2.1%
2/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Infections and infestations
Streptococcal infection
|
1.0%
1/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Infections and infestations
Subcutaneous abscess
|
1.0%
1/96 • 38 months
|
15.5%
15/97 • 38 months
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
1.0%
1/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
General disorders
Swelling face
|
0.00%
0/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Eye disorders
Swelling of eyelid
|
1.0%
1/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Nervous system disorders
Syncope
|
0.00%
0/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Cardiac disorders
Tachycardia
|
2.1%
2/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
2.1%
2/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Gastrointestinal disorders
Terminal ileitis
|
1.0%
1/96 • 38 months
|
2.1%
2/97 • 38 months
|
|
General disorders
Thirst
|
0.00%
0/96 • 38 months
|
4.1%
4/97 • 38 months
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
1.0%
1/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
1.0%
1/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
18.8%
18/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Vascular disorders
Thrombophlebitis
|
1.0%
1/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Vascular disorders
Thrombophlebitis superficial
|
2.1%
2/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Gastrointestinal disorders
Tooth disorder
|
0.00%
0/96 • 38 months
|
14.4%
14/97 • 38 months
|
|
Infections and infestations
Tooth infection
|
2.1%
2/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Gastrointestinal disorders
Toothache
|
1.0%
1/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Investigations
Transaminases increased
|
2.1%
2/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.00%
0/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Investigations
Troponin I increased
|
1.0%
1/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.00%
0/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Renal and urinary disorders
Urethral pain
|
1.0%
1/96 • 38 months
|
2.1%
2/97 • 38 months
|
|
Renal and urinary disorders
Urinary hesitation
|
1.0%
1/96 • 38 months
|
2.1%
2/97 • 38 months
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/96 • 38 months
|
6.2%
6/97 • 38 months
|
|
Renal and urinary disorders
Urinary retention
|
3.1%
3/96 • 38 months
|
2.1%
2/97 • 38 months
|
|
Infections and infestations
Urinary tract infection
|
2.1%
2/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.0%
1/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
1.0%
1/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Cardiac disorders
Ventricular arrhythmia
|
1.0%
1/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Eye disorders
Vision blurred
|
2.1%
2/96 • 38 months
|
3.1%
3/97 • 38 months
|
|
Eye disorders
Visual acuity reduced
|
1.0%
1/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Eye disorders
Visual field defect
|
0.00%
0/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Eye disorders
Visual impairment
|
0.00%
0/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Gastrointestinal disorders
Vomiting
|
10.4%
10/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Gastrointestinal disorders
Vomiting projectile
|
0.00%
0/96 • 38 months
|
0.00%
0/97 • 38 months
|
|
Investigations
Weight decreased
|
1.0%
1/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Investigations
Weight increased
|
2.1%
2/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
1.0%
1/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Investigations
White blood cell count decreased
|
15.6%
15/96 • 38 months
|
14.4%
14/97 • 38 months
|
|
Injury, poisoning and procedural complications
Wound
|
1.0%
1/96 • 38 months
|
1.0%
1/97 • 38 months
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/96 • 38 months
|
2.1%
2/97 • 38 months
|
|
Blood and lymphatic system disorders
Anaemia
|
34.4%
33/96 • 38 months
|
2.1%
2/97 • 38 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
1.0%
1/96 • 38 months
|
4.1%
4/97 • 38 months
|
|
Product Issues
Device occlusion
|
0.00%
0/96 • 38 months
|
13.4%
13/97 • 38 months
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/96 • 38 months
|
0.00%
0/97 • 38 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place