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Trial record 17 of 1900 for:    Diseases | ( Map: Puerto Rico )

Strategies Using Darbepoetin Alfa to Avoid Transfusions in Chronic Kidney Disease (START-CKD)

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ClinicalTrials.gov Identifier: NCT01652872
Recruitment Status : Completed
First Posted : July 30, 2012
Results First Posted : November 8, 2018
Last Update Posted : December 12, 2018
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Anemia in Chronic Kidney Disease Patients Not on Dialysis
Interventions Biological: Darbepoetin alfa
Other: Placebo
Enrollment 756
Recruitment Details Anemic participants with chronic kidney disease and not on dialysis (CKD-ND) were enrolled at 126 study centers in the United States, from 30 July 2012 to 19 October 2017. The on-study duration was approximately 2 years, comprising of a 2- to 4-week screening period, a 96-week treatment period and a 4-week follow up period.
Pre-assignment Details Participants were randomized in a 1:1 ratio to 1 of 2 darbepoetin alfa dosing strategies (hemoglobin [Hb]-based titration group or fixed dose group). Randomization was stratified by red blood cell (RBC) transfusion received within 12 months prior to randomization (yes/no) and site practice setting (nephrology/non-nephrology).
Arm/Group Title Hb-Based Titration Group Fixed Dose Group
Hide Arm/Group Description Participants received darbepoetin alfa as a subcutaneous (SC) injection once every 4 weeks (Q4W) for up to 96 weeks. The dose of darbepoetin alfa was titrated based on the Hb concentration on the date of the visit, the corresponding Hb rate of rise (ROR), and the previously assigned dose. Doses were reduced if Hb exceeded 10.5 grams/deciliter (g/dL) or Hb ROR exceeded 1.0 g/dL/4W. When darbepoetin alfa therapy was withheld per the dosing algorithm, placebo was administered. The starting dose of darbepoetin alfa was 0.45 micrograms/kilogram (mcg/kg) and the protocol specified doses ranged from 10 to 300 mcg. Participants received darbepoetin alfa as a SC injection Q4W at the same dose as assigned at the time of randomization for the duration of the 96-week treatment period. There was 1 exception to the fixed dose strategy: if the Hb was > 12.0 g/dL, darbepoetin alfa therapy was withheld and placebo administered. Once the Hb fell to < 10.0 g/dL, darbepoetin alfa therapy resumed at the same dose. The starting dose of darbepoetin alfa was 0.45 mcg/kg and the protocol specified doses ranged from 10 to 300 mcg.
Period Title: Overall Study
Started 377 379
Received Investigational Product 377 377
Completed 232 226
Not Completed 145 153
Reason Not Completed
Death             36             39
Lost to Follow-up             28             23
Decision by sponsor             5             7
Withdrawal by Subject             76             84
Arm/Group Title Hb-Based Titration Group Fixed Dose Group Total
Hide Arm/Group Description Participants received darbepoetin alfa as a SC injection, Q4W for up to 96 weeks. The dose of darbepoetin alfa was titrated based on the Hb concentration on the date of the visit, the corresponding Hb ROR, and the previously assigned dose. Doses were reduced if Hb exceeded 10.5 g/dL or Hb ROR exceeded 1.0 g/dL/4W. When darbepoetin alfa therapy was withheld per the dosing algorithm, placebo was administered. The starting dose of darbepoetin alfa was 0.45 mcg/kg and the protocol specified doses ranged from 10 to 300 mcg. Participants received darbepoetin alfa as a SC injection Q4W at the same dose as assigned at the time of randomization for the duration of the 96-week treatment period. There was 1 exception to the fixed dose strategy: if the Hb was > 12.0 g/dL, darbepoetin alfa therapy was withheld and placebo administered. Once the Hb fell to < 10.0 g/dL, darbepoetin alfa therapy resumed at the same dose. The starting dose of darbepoetin alfa was 0.45 mcg/kg and the protocol specified doses ranged from 10 to 300 mcg. Total of all reporting groups
Overall Number of Baseline Participants 377 379 756
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 377 participants 379 participants 756 participants
69.2  (13.5) 69.5  (13.1) 69.4  (13.3)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 377 participants 379 participants 756 participants
18 - 64 years
129
  34.2%
134
  35.4%
263
  34.8%
65 - 74 years
97
  25.7%
96
  25.3%
193
  25.5%
75 - 84 years
105
  27.9%
97
  25.6%
202
  26.7%
>=85 years
46
  12.2%
52
  13.7%
98
  13.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 377 participants 379 participants 756 participants
Female
223
  59.2%
218
  57.5%
441
  58.3%
Male
154
  40.8%
161
  42.5%
315
  41.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 377 participants 379 participants 756 participants
Hispanic or Latino
92
  24.4%
95
  25.1%
187
  24.7%
Not Hispanic or Latino
285
  75.6%
284
  74.9%
569
  75.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 377 participants 379 participants 756 participants
American Indian or Alaska Native
1
   0.3%
0
   0.0%
1
   0.1%
Asian
25
   6.6%
21
   5.5%
46
   6.1%
Black or African American
125
  33.2%
134
  35.4%
259
  34.3%
Native Hawaiian or Other Pacific Islander
5
   1.3%
4
   1.1%
9
   1.2%
White
220
  58.4%
215
  56.7%
435
  57.5%
Mixed race/Other
1
   0.3%
5
   1.3%
6
   0.8%
Previous RBC transfusions  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 377 participants 379 participants 756 participants
Yes
145
  38.5%
140
  36.9%
285
  37.7%
No
232
  61.5%
239
  63.1%
471
  62.3%
1.Primary Outcome
Title Percentage of Participants in Receipt of 1 or More RBC Transfusions
Hide Description The percentage of participants receiving at least 1 RBC transfusion during the evaluation period was recorded for each treatment group. The evaluation period began from the date of randomization, and participants were censored at the last dose of investigational product plus 3 months or end of study, whichever was earlier (on-treatment approach).
Time Frame From randomization until the end of study, up to week 101.
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all randomized participants who received at least 1 dose of investigational product.
Arm/Group Title Hb-Based Titration Group Fixed Dose Group
Hide Arm/Group Description:
Participants received darbepoetin alfa as a SC injection, Q4W for up to 96 weeks. The dose of darbepoetin alfa was titrated based on the Hb concentration on the date of the visit, the corresponding Hb ROR, and the previously assigned dose. Doses were reduced if Hb exceeded 10.5 g/dL or Hb ROR exceeded 1.0 g/dL/4W. When darbepoetin alfa therapy was withheld per the dosing algorithm, placebo was administered. The starting dose of darbepoetin alfa was 0.45 mcg/kg and the protocol specified doses ranged from 10 to 300 mcg.
Participants received darbepoetin alfa as a SC injection Q4W at the same dose as assigned at the time of randomization for the duration of the 96-week treatment period. There was 1 exception to the fixed dose strategy: if the Hb was > 12.0 g/dL, darbepoetin alfa therapy was withheld and placebo administered. Once the Hb fell to < 10.0 g/dL, darbepoetin alfa therapy resumed at the same dose. The starting dose of darbepoetin alfa was 0.45 mcg/kg and the protocol specified doses ranged from 10 to 300 mcg.
Overall Number of Participants Analyzed 377 377
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
24.40
(20.07 to 28.74)
24.14
(19.82 to 28.46)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Hb-Based Titration Group, Fixed Dose Group
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment Difference
Estimated Value -0.27
Confidence Interval (2-Sided) 95%
-6.39 to 5.85
Estimation Comments Difference is fixed dose - titration.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Hb-Based Titration Group, Fixed Dose Group
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by RBC transfusion received within 12 months prior to randomization (yes/no) and site practice setting (nephrology/non-nephrology).
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.998
Confidence Interval (2-Sided) 95%
0.776 to 1.285
Estimation Comments A risk ratio < 1.0 indicates a lower event rate for the fixed dose group relative to Hb-based titration group.
2.Secondary Outcome
Title Mean Number of Units of RBC Transfused
Hide Description The total number of units of RBC transfused per participant during the evaluation period was recorded for each treatment group. The evaluation period began from the date of randomization, and participants were censored at the last dose of investigational product plus 3 months or end of study, whichever was earlier (on-treatment approach). The mean total number of RBC units transfused per participant is presented.
Time Frame From randomization until the end of study, up to week 101.
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all randomized participants who received at least 1 dose of investigational product.
Arm/Group Title Hb-Based Titration Group Fixed Dose Group
Hide Arm/Group Description:
Participants received darbepoetin alfa as a SC injection, Q4W for up to 96 weeks. The dose of darbepoetin alfa was titrated based on the Hb concentration on the date of the visit, the corresponding Hb ROR, and the previously assigned dose. Doses were reduced if Hb exceeded 10.5 g/dL or Hb ROR exceeded 1.0 g/dL/4W. When darbepoetin alfa therapy was withheld per the dosing algorithm, placebo was administered. The starting dose of darbepoetin alfa was 0.45 mcg/kg and the protocol specified doses ranged from 10 to 300 mcg.
Participants received darbepoetin alfa as a SC injection Q4W at the same dose as assigned at the time of randomization for the duration of the 96-week treatment period. There was 1 exception to the fixed dose strategy: if the Hb was > 12.0 g/dL, darbepoetin alfa therapy was withheld and placebo administered. Once the Hb fell to < 10.0 g/dL, darbepoetin alfa therapy resumed at the same dose. The starting dose of darbepoetin alfa was 0.45 mcg/kg and the protocol specified doses ranged from 10 to 300 mcg.
Overall Number of Participants Analyzed 377 377
Mean (95% Confidence Interval)
Unit of Measure: Units of transfused RBC
0.71
(0.53 to 0.89)
0.87
(0.65 to 1.10)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Hb-Based Titration Group, Fixed Dose Group
Comments [Not Specified]
Type of Statistical Test Other
Comments Stratified by RBC transfusion received within 12 months prior to randomization (yes/no) and site practice setting (nephrology/non-nephrology) and accounting for participant exposure time.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Negative binomial regression model
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean (LSM) Ratio
Estimated Value 1.28
Confidence Interval (2-Sided) 95%
0.81 to 2.05
Estimation Comments Least Squares Mean (LSM) ratio is fixed dose relative to titration.
3.Secondary Outcome
Title Time to First RBC Transfusion
Hide Description Time to first RBC transfusion during the evaluation period was recorded for each treatment group. The evaluation period began from the date of randomization, and participants were censored at the last dose of investigational product plus 3 months or end of study, whichever was earlier (on-treatment approach). The time to first RBC transfusion is presented using Kaplan-Meier (KM) estimates at 6, 12, 18, and 24 months.
Time Frame From randomization until the end of study, up to week 101.
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all randomized participants who received at least 1 dose of investigational product.
Arm/Group Title Hb-Based Titration Group Fixed Dose Group
Hide Arm/Group Description:
Participants received darbepoetin alfa as a SC injection, Q4W for up to 96 weeks. The dose of darbepoetin alfa was titrated based on the Hb concentration on the date of the visit, the corresponding Hb ROR, and the previously assigned dose. Doses were reduced if Hb exceeded 10.5 g/dL or Hb ROR exceeded 1.0 g/dL/4W. When darbepoetin alfa therapy was withheld per the dosing algorithm, placebo was administered. The starting dose of darbepoetin alfa was 0.45 mcg/kg and the protocol specified doses ranged from 10 to 300 mcg.
Participants received darbepoetin alfa as a SC injection Q4W at the same dose as assigned at the time of randomization for the duration of the 96-week treatment period. There was 1 exception to the fixed dose strategy: if the Hb was > 12.0 g/dL, darbepoetin alfa therapy was withheld and placebo administered. Once the Hb fell to < 10.0 g/dL, darbepoetin alfa therapy resumed at the same dose. The starting dose of darbepoetin alfa was 0.45 mcg/kg and the protocol specified doses ranged from 10 to 300 mcg.
Overall Number of Participants Analyzed 377 377
Measure Type: Number
Unit of Measure: Months
KM estimates at month 6 0.115 0.136
KM estimates at month 12 0.192 0.204
KM estimates at month 18 0.261 0.246
KM estimates at month 24 0.297 0.289
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Hb-Based Titration Group, Fixed Dose Group
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Cox Proportional Hazard Model
Comments Stratified by RBC transfusion received within 12 months prior to randomization (yes/no) and site practice setting (nephrology/non-nephrology).
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.01
Confidence Interval (2-Sided) 95%
0.76 to 1.35
Estimation Comments Hazard ratio is fixed dose relative to titration.
4.Secondary Outcome
Title Mean Achieved Hb Concentration While Receiving Investigational Product
Hide Description Average achieved Hb concentration while receiving investigational product was recorded as mean Hb using the area under the curve (AUC) method for each treatment group. The AUC of Hb was calculated according to the trapezoidal method, standardized as daily AUC. Participants with available Hb values from study day 85 (week 13) to the last dose date were included in the calculation.
Time Frame From week 13 until the end of study, up to week 101.
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all randomized participants who received at least 1 dose of investigational product.
Arm/Group Title Hb-Based Titration Group Fixed Dose Group
Hide Arm/Group Description:
Participants received darbepoetin alfa as a SC injection, Q4W for up to 96 weeks. The dose of darbepoetin alfa was titrated based on the Hb concentration on the date of the visit, the corresponding Hb ROR, and the previously assigned dose. Doses were reduced if Hb exceeded 10.5 g/dL or Hb ROR exceeded 1.0 g/dL/4W. When darbepoetin alfa therapy was withheld per the dosing algorithm, placebo was administered. The starting dose of darbepoetin alfa was 0.45 mcg/kg and the protocol specified doses ranged from 10 to 300 mcg.
Participants received darbepoetin alfa as a SC injection Q4W at the same dose as assigned at the time of randomization for the duration of the 96-week treatment period. There was 1 exception to the fixed dose strategy: if the Hb was > 12.0 g/dL, darbepoetin alfa therapy was withheld and placebo administered. Once the Hb fell to < 10.0 g/dL, darbepoetin alfa therapy resumed at the same dose. The starting dose of darbepoetin alfa was 0.45 mcg/kg and the protocol specified doses ranged from 10 to 300 mcg.
Overall Number of Participants Analyzed 377 377
Mean (Standard Error)
Unit of Measure: g/dL
9.71  (0.04) 9.41  (0.05)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Hb-Based Titration Group, Fixed Dose Group
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Hodges-Lehmann estimate
Comments [Not Specified]
Method of Estimation Estimation Parameter Median of the difference
Estimated Value -0.34
Confidence Interval (2-Sided) 95%
-0.46 to -0.22
Estimation Comments Difference is fixed dose - titration.
Other Statistical Analysis The 2-sided 95% confidence intervals were obtained using a non-parametric Wilcoxon rank-sum statistic.
5.Secondary Outcome
Title Geometric Mean Cumulative Dose of Darbepoetin Alfa Per 4 Weeks
Hide Description Cumulative doses of darbepoetin alfa adjusted for investigation product exposure time (e.g. mean cumulative darbepoetin alfa dose per 4 weeks) were calculated for each treatment group using the total cumulative dose during the study divided by total number of weeks dosed then multiplied by 4. The geometric mean cumulative dose is presented.
Time Frame From randomization until the end of study, up to week 101.
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all randomized participants who received at least 1 dose of investigational product.
Arm/Group Title Hb-Based Titration Group Fixed Dose Group
Hide Arm/Group Description:
Participants received darbepoetin alfa as a SC injection, Q4W for up to 96 weeks. The dose of darbepoetin alfa was titrated based on the Hb concentration on the date of the visit, the corresponding Hb ROR, and the previously assigned dose. Doses were reduced if Hb exceeded 10.5 g/dL or Hb ROR exceeded 1.0 g/dL/4W. When darbepoetin alfa therapy was withheld per the dosing algorithm, placebo was administered. The starting dose of darbepoetin alfa was 0.45 mcg/kg and the protocol specified doses ranged from 10 to 300 mcg.
Participants received darbepoetin alfa as a SC injection Q4W at the same dose as assigned at the time of randomization for the duration of the 96-week treatment period. There was 1 exception to the fixed dose strategy: if the Hb was > 12.0 g/dL, darbepoetin alfa therapy was withheld and placebo administered. Once the Hb fell to < 10.0 g/dL, darbepoetin alfa therapy resumed at the same dose. The starting dose of darbepoetin alfa was 0.45 mcg/kg and the protocol specified doses ranged from 10 to 300 mcg.
Overall Number of Participants Analyzed 377 377
Geometric Mean (Standard Error)
Unit of Measure: mcg
50.7  (2.7) 30.8  (1.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Hb-Based Titration Group
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Hodges-Lehmann estimate
Comments [Not Specified]
Method of Estimation Estimation Parameter Median of the difference
Estimated Value -22.1
Confidence Interval (2-Sided) 95%
-26.1 to -18.1
Estimation Comments Difference is fixed dose - titration.
Other Statistical Analysis The 2-sided 95% confidence intervals were obtained using a non-parametric Wilcoxon rank-sum statistic.
Time Frame Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks).
Adverse Event Reporting Description Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
 
Arm/Group Title Hb-Based Titration Group Fixed Dose Group
Hide Arm/Group Description Participants received darbepoetin alfa as a SC injection, Q4W for up to 96 weeks. The dose of darbepoetin alfa was titrated based on the Hb concentration on the date of the visit, the corresponding Hb ROR, and the previously assigned dose. Doses were reduced if Hb exceeded 10.5 g/dL or Hb ROR exceeded 1.0 g/dL/4W. When darbepoetin alfa therapy was withheld per the dosing algorithm, placebo was administered. The starting dose of darbepoetin alfa was 0.45 mcg/kg and the protocol specified doses ranged from 10 to 300 mcg. Participants received darbepoetin alfa as a SC injection Q4W at the same dose as assigned at the time of randomization for the duration of the 96-week treatment period. There was 1 exception to the fixed dose strategy: if the Hb was > 12.0 g/dL, darbepoetin alfa therapy was withheld and placebo administered. Once the Hb fell to < 10.0 g/dL, darbepoetin alfa therapy resumed at the same dose. The starting dose of darbepoetin alfa was 0.45 mcg/kg and the protocol specified doses ranged from 10 to 300 mcg.
All-Cause Mortality
Hb-Based Titration Group Fixed Dose Group
Affected / at Risk (%) Affected / at Risk (%)
Total   38/377 (10.08%)   38/377 (10.08%) 
Show Serious Adverse Events Hide Serious Adverse Events
Hb-Based Titration Group Fixed Dose Group
Affected / at Risk (%) Affected / at Risk (%)
Total   190/377 (50.40%)   175/377 (46.42%) 
Blood and lymphatic system disorders     
Anaemia  1  24/377 (6.37%)  29/377 (7.69%) 
Anaemia of chronic disease  1  1/377 (0.27%)  0/377 (0.00%) 
Coagulopathy  1  0/377 (0.00%)  1/377 (0.27%) 
Hyperprothrombinaemia  1  0/377 (0.00%)  1/377 (0.27%) 
Leukocytosis  1  1/377 (0.27%)  1/377 (0.27%) 
Leukopenia  1  0/377 (0.00%)  1/377 (0.27%) 
Microcytic anaemia  1  0/377 (0.00%)  1/377 (0.27%) 
Nephrogenic anaemia  1  1/377 (0.27%)  0/377 (0.00%) 
Thrombocytopenia  1  0/377 (0.00%)  2/377 (0.53%) 
Cardiac disorders     
Acute coronary syndrome  1  1/377 (0.27%)  0/377 (0.00%) 
Acute left ventricular failure  1  0/377 (0.00%)  1/377 (0.27%) 
Acute myocardial infarction  1  5/377 (1.33%)  5/377 (1.33%) 
Angina pectoris  1  3/377 (0.80%)  2/377 (0.53%) 
Angina unstable  1  1/377 (0.27%)  1/377 (0.27%) 
Aortic valve stenosis  1  1/377 (0.27%)  0/377 (0.00%) 
Atrial fibrillation  1  0/377 (0.00%)  2/377 (0.53%) 
Atrial flutter  1  1/377 (0.27%)  0/377 (0.00%) 
Atrioventricular block complete  1  0/377 (0.00%)  1/377 (0.27%) 
Bradycardia  1  4/377 (1.06%)  1/377 (0.27%) 
Cardiac arrest  1  3/377 (0.80%)  3/377 (0.80%) 
Cardiac disorder  1  0/377 (0.00%)  1/377 (0.27%) 
Cardiac failure  1  11/377 (2.92%)  7/377 (1.86%) 
Cardiac failure acute  1  2/377 (0.53%)  2/377 (0.53%) 
Cardiac failure chronic  1  1/377 (0.27%)  0/377 (0.00%) 
Cardiac failure congestive  1  28/377 (7.43%)  17/377 (4.51%) 
Cardiac ventricular thrombosis  1  1/377 (0.27%)  0/377 (0.00%) 
Cardiogenic shock  1  1/377 (0.27%)  0/377 (0.00%) 
Coronary artery disease  1  1/377 (0.27%)  3/377 (0.80%) 
Diastolic dysfunction  1  1/377 (0.27%)  0/377 (0.00%) 
Hypertensive heart disease  1  1/377 (0.27%)  0/377 (0.00%) 
Ischaemic cardiomyopathy  1  1/377 (0.27%)  0/377 (0.00%) 
Left ventricular dysfunction  1  0/377 (0.00%)  1/377 (0.27%) 
Left ventricular failure  1  1/377 (0.27%)  3/377 (0.80%) 
Mitral valve stenosis  1  0/377 (0.00%)  1/377 (0.27%) 
Myocardial infarction  1  5/377 (1.33%)  1/377 (0.27%) 
Myocardial ischaemia  1  1/377 (0.27%)  0/377 (0.00%) 
Nodal arrhythmia  1  0/377 (0.00%)  1/377 (0.27%) 
Sinus arrest  1  1/377 (0.27%)  0/377 (0.00%) 
Sinus bradycardia  1  1/377 (0.27%)  0/377 (0.00%) 
Tachyarrhythmia  1  0/377 (0.00%)  1/377 (0.27%) 
Congenital, familial and genetic disorders     
Gastrointestinal arteriovenous malformation  1  0/377 (0.00%)  1/377 (0.27%) 
Endocrine disorders     
Hypothyroidism  1  1/377 (0.27%)  2/377 (0.53%) 
Gastrointestinal disorders     
Abdominal distension  1  0/377 (0.00%)  1/377 (0.27%) 
Abdominal pain  1  1/377 (0.27%)  3/377 (0.80%) 
Ascites  1  0/377 (0.00%)  1/377 (0.27%) 
Colitis  1  0/377 (0.00%)  1/377 (0.27%) 
Constipation  1  1/377 (0.27%)  0/377 (0.00%) 
Diarrhoea  1  1/377 (0.27%)  4/377 (1.06%) 
Diarrhoea haemorrhagic  1  1/377 (0.27%)  0/377 (0.00%) 
Diverticulum  1  1/377 (0.27%)  1/377 (0.27%) 
Diverticulum intestinal haemorrhagic  1  1/377 (0.27%)  0/377 (0.00%) 
Duodenal ulcer  1  0/377 (0.00%)  1/377 (0.27%) 
Gastritis  1  1/377 (0.27%)  0/377 (0.00%) 
Gastrointestinal haemorrhage  1  8/377 (2.12%)  6/377 (1.59%) 
Gastrooesophageal reflux disease  1  0/377 (0.00%)  2/377 (0.53%) 
Haemorrhoidal haemorrhage  1  0/377 (0.00%)  2/377 (0.53%) 
Ileus paralytic  1  0/377 (0.00%)  1/377 (0.27%) 
Impaired gastric emptying  1  1/377 (0.27%)  0/377 (0.00%) 
Large intestine polyp  1  1/377 (0.27%)  0/377 (0.00%) 
Lower gastrointestinal haemorrhage  1  1/377 (0.27%)  0/377 (0.00%) 
Melaena  1  1/377 (0.27%)  1/377 (0.27%) 
Nausea  1  1/377 (0.27%)  0/377 (0.00%) 
Oesophagitis  1  0/377 (0.00%)  1/377 (0.27%) 
Pancreatic mass  1  1/377 (0.27%)  0/377 (0.00%) 
Pancreatitis  1  1/377 (0.27%)  1/377 (0.27%) 
Pancreatitis acute  1  3/377 (0.80%)  1/377 (0.27%) 
Pancreatitis chronic  1  1/377 (0.27%)  0/377 (0.00%) 
Small intestinal obstruction  1  0/377 (0.00%)  2/377 (0.53%) 
Upper gastrointestinal haemorrhage  1  1/377 (0.27%)  0/377 (0.00%) 
Vomiting  1  2/377 (0.53%)  4/377 (1.06%) 
General disorders     
Asthenia  1  4/377 (1.06%)  0/377 (0.00%) 
Chest discomfort  1  1/377 (0.27%)  0/377 (0.00%) 
Chest pain  1  1/377 (0.27%)  3/377 (0.80%) 
Death  1  2/377 (0.53%)  0/377 (0.00%) 
Fatigue  1  1/377 (0.27%)  0/377 (0.00%) 
Generalised oedema  1  2/377 (0.53%)  2/377 (0.53%) 
Hypothermia  1  0/377 (0.00%)  2/377 (0.53%) 
Influenza like illness  1  1/377 (0.27%)  0/377 (0.00%) 
Non-cardiac chest pain  1  6/377 (1.59%)  1/377 (0.27%) 
Oedema peripheral  1  4/377 (1.06%)  2/377 (0.53%) 
Peripheral swelling  1  1/377 (0.27%)  0/377 (0.00%) 
Pneumatosis  1  0/377 (0.00%)  1/377 (0.27%) 
Pyrexia  1  2/377 (0.53%)  0/377 (0.00%) 
Hepatobiliary disorders     
Cholelithiasis  1  2/377 (0.53%)  2/377 (0.53%) 
Hepatic cirrhosis  1  2/377 (0.53%)  0/377 (0.00%) 
Infections and infestations     
Abscess limb  1  0/377 (0.00%)  1/377 (0.27%) 
Bacteraemia  1  1/377 (0.27%)  0/377 (0.00%) 
Bacterial sepsis  1  0/377 (0.00%)  1/377 (0.27%) 
Brain abscess  1  1/377 (0.27%)  0/377 (0.00%) 
Bronchitis  1  3/377 (0.80%)  1/377 (0.27%) 
Cellulitis  1  3/377 (0.80%)  5/377 (1.33%) 
Cholecystitis infective  1  1/377 (0.27%)  0/377 (0.00%) 
Device related infection  1  0/377 (0.00%)  1/377 (0.27%) 
Diverticulitis  1  2/377 (0.53%)  0/377 (0.00%) 
Emphysematous pyelonephritis  1  1/377 (0.27%)  0/377 (0.00%) 
Escherichia infection  1  0/377 (0.00%)  1/377 (0.27%) 
Escherichia urinary tract infection  1  1/377 (0.27%)  1/377 (0.27%) 
Gangrene  1  1/377 (0.27%)  1/377 (0.27%) 
Gastroenteritis  1  3/377 (0.80%)  1/377 (0.27%) 
Influenza  1  1/377 (0.27%)  0/377 (0.00%) 
Mycobacterium kansasii infection  1  1/377 (0.27%)  0/377 (0.00%) 
Osteomyelitis  1  2/377 (0.53%)  3/377 (0.80%) 
Osteomyelitis acute  1  1/377 (0.27%)  0/377 (0.00%) 
Pneumonia  1  15/377 (3.98%)  18/377 (4.77%) 
Pneumonia bacterial  1  0/377 (0.00%)  2/377 (0.53%) 
Pyelonephritis  1  0/377 (0.00%)  1/377 (0.27%) 
Pyelonephritis acute  1  0/377 (0.00%)  1/377 (0.27%) 
Pyuria  1  0/377 (0.00%)  1/377 (0.27%) 
Sepsis  1  6/377 (1.59%)  3/377 (0.80%) 
Septic shock  1  1/377 (0.27%)  2/377 (0.53%) 
Staphylococcal abscess  1  0/377 (0.00%)  1/377 (0.27%) 
Staphylococcal infection  1  0/377 (0.00%)  2/377 (0.53%) 
Staphylococcal sepsis  1  0/377 (0.00%)  1/377 (0.27%) 
Streptococcal urinary tract infection  1  0/377 (0.00%)  1/377 (0.27%) 
Upper respiratory tract infection  1  1/377 (0.27%)  0/377 (0.00%) 
Urinary tract infection  1  9/377 (2.39%)  11/377 (2.92%) 
Urinary tract infection bacterial  1  2/377 (0.53%)  2/377 (0.53%) 
Injury, poisoning and procedural complications     
Acetabulum fracture  1  0/377 (0.00%)  1/377 (0.27%) 
Alcohol poisoning  1  0/377 (0.00%)  1/377 (0.27%) 
Anaemia postoperative  1  0/377 (0.00%)  1/377 (0.27%) 
Clavicle fracture  1  1/377 (0.27%)  0/377 (0.00%) 
Contusion  1  1/377 (0.27%)  0/377 (0.00%) 
Fall  1  10/377 (2.65%)  2/377 (0.53%) 
Femur fracture  1  4/377 (1.06%)  0/377 (0.00%) 
Fractured sacrum  1  1/377 (0.27%)  0/377 (0.00%) 
Haematuria traumatic  1  1/377 (0.27%)  0/377 (0.00%) 
Head injury  1  2/377 (0.53%)  0/377 (0.00%) 
Hip fracture  1  1/377 (0.27%)  1/377 (0.27%) 
Humerus fracture  1  1/377 (0.27%)  0/377 (0.00%) 
Overdose  1  1/377 (0.27%)  0/377 (0.00%) 
Patella fracture  1  1/377 (0.27%)  0/377 (0.00%) 
Pelvic fracture  1  1/377 (0.27%)  0/377 (0.00%) 
Post procedural complication  1  0/377 (0.00%)  1/377 (0.27%) 
Post procedural haemorrhage  1  0/377 (0.00%)  1/377 (0.27%) 
Procedural haemorrhage  1  0/377 (0.00%)  1/377 (0.27%) 
Rib fracture  1  1/377 (0.27%)  1/377 (0.27%) 
Road traffic accident  1  1/377 (0.27%)  0/377 (0.00%) 
Spinal compression fracture  1  0/377 (0.00%)  1/377 (0.27%) 
Subarachnoid haemorrhage  1  1/377 (0.27%)  0/377 (0.00%) 
Subdural haematoma  1  1/377 (0.27%)  0/377 (0.00%) 
Tibia fracture  1  0/377 (0.00%)  1/377 (0.27%) 
Wrist fracture  1  1/377 (0.27%)  0/377 (0.00%) 
Investigations     
Acid base balance abnormal  1  0/377 (0.00%)  1/377 (0.27%) 
Blood creatinine increased  1  1/377 (0.27%)  0/377 (0.00%) 
Blood potassium increased  1  0/377 (0.00%)  1/377 (0.27%) 
ECG signs of myocardial ischaemia  1  1/377 (0.27%)  0/377 (0.00%) 
International normalised ratio increased  1  0/377 (0.00%)  1/377 (0.27%) 
Platelet count decreased  1  0/377 (0.00%)  1/377 (0.27%) 
Transaminases increased  1  0/377 (0.00%)  1/377 (0.27%) 
Troponin increased  1  1/377 (0.27%)  0/377 (0.00%) 
Urine output decreased  1  0/377 (0.00%)  1/377 (0.27%) 
Weight decreased  1  1/377 (0.27%)  0/377 (0.00%) 
Metabolism and nutrition disorders     
Acidosis  1  1/377 (0.27%)  0/377 (0.00%) 
Acidosis hyperchloraemic  1  0/377 (0.00%)  1/377 (0.27%) 
Decreased appetite  1  2/377 (0.53%)  0/377 (0.00%) 
Dehydration  1  5/377 (1.33%)  4/377 (1.06%) 
Diabetes mellitus inadequate control  1  1/377 (0.27%)  0/377 (0.00%) 
Diabetic ketoacidosis  1  2/377 (0.53%)  2/377 (0.53%) 
Failure to thrive  1  1/377 (0.27%)  1/377 (0.27%) 
Fluid overload  1  10/377 (2.65%)  5/377 (1.33%) 
Gout  1  2/377 (0.53%)  1/377 (0.27%) 
Hypercalcaemia  1  1/377 (0.27%)  1/377 (0.27%) 
Hyperglycaemia  1  4/377 (1.06%)  1/377 (0.27%) 
Hyperinsulinaemic hypoglycaemia  1  1/377 (0.27%)  0/377 (0.00%) 
Hyperkalaemia  1  10/377 (2.65%)  11/377 (2.92%) 
Hypocalcaemia  1  1/377 (0.27%)  0/377 (0.00%) 
Hypoglycaemia  1  4/377 (1.06%)  8/377 (2.12%) 
Hypokalaemia  1  0/377 (0.00%)  2/377 (0.53%) 
Hypomagnesaemia  1  2/377 (0.53%)  2/377 (0.53%) 
Hyponatraemia  1  1/377 (0.27%)  3/377 (0.80%) 
Hypophosphataemia  1  1/377 (0.27%)  0/377 (0.00%) 
Metabolic acidosis  1  2/377 (0.53%)  1/377 (0.27%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  0/377 (0.00%)  2/377 (0.53%) 
Back pain  1  1/377 (0.27%)  0/377 (0.00%) 
Costochondritis  1  0/377 (0.00%)  1/377 (0.27%) 
Flank pain  1  0/377 (0.00%)  2/377 (0.53%) 
Lumbar spinal stenosis  1  1/377 (0.27%)  0/377 (0.00%) 
Muscular weakness  1  1/377 (0.27%)  2/377 (0.53%) 
Osteoarthritis  1  0/377 (0.00%)  3/377 (0.80%) 
Pain in extremity  1  0/377 (0.00%)  1/377 (0.27%) 
Psoriatic arthropathy  1  1/377 (0.27%)  0/377 (0.00%) 
Rhabdomyolysis  1  0/377 (0.00%)  1/377 (0.27%) 
Systemic lupus erythematosus  1  0/377 (0.00%)  1/377 (0.27%) 
Tenosynovitis  1  1/377 (0.27%)  0/377 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Acute leukaemia  1  0/377 (0.00%)  1/377 (0.27%) 
Gastric cancer  1  1/377 (0.27%)  0/377 (0.00%) 
Gastrointestinal tract adenoma  1  0/377 (0.00%)  1/377 (0.27%) 
Hepatocellular carcinoma  1  0/377 (0.00%)  1/377 (0.27%) 
Invasive ductal breast carcinoma  1  1/377 (0.27%)  0/377 (0.00%) 
Lung adenocarcinoma  1  1/377 (0.27%)  0/377 (0.00%) 
Lung cancer metastatic  1  1/377 (0.27%)  0/377 (0.00%) 
Metastatic lymphoma  1  1/377 (0.27%)  0/377 (0.00%) 
Non-Hodgkin's lymphoma  1  1/377 (0.27%)  0/377 (0.00%) 
Non-small cell lung cancer stage I  1  0/377 (0.00%)  1/377 (0.27%) 
Pancreatic carcinoma metastatic  1  0/377 (0.00%)  1/377 (0.27%) 
Papillary thyroid cancer  1  0/377 (0.00%)  1/377 (0.27%) 
Prostate cancer  1  0/377 (0.00%)  2/377 (0.53%) 
Squamous cell carcinoma of lung  1  2/377 (0.53%)  0/377 (0.00%) 
Thymoma  1  1/377 (0.27%)  0/377 (0.00%) 
Thyroid cancer  1  0/377 (0.00%)  1/377 (0.27%) 
Nervous system disorders     
Brain oedema  1  1/377 (0.27%)  0/377 (0.00%) 
Carotid artery stenosis  1  0/377 (0.00%)  1/377 (0.27%) 
Cerebral arteriosclerosis  1  0/377 (0.00%)  1/377 (0.27%) 
Cerebral haematoma  1  1/377 (0.27%)  0/377 (0.00%) 
Cerebral haemorrhage  1  2/377 (0.53%)  0/377 (0.00%) 
Cerebrovascular accident  1  1/377 (0.27%)  2/377 (0.53%) 
Dementia  1  0/377 (0.00%)  1/377 (0.27%) 
Dizziness  1  0/377 (0.00%)  3/377 (0.80%) 
Dysarthria  1  0/377 (0.00%)  2/377 (0.53%) 
Encephalopathy  1  2/377 (0.53%)  1/377 (0.27%) 
Haemorrhage intracranial  1  2/377 (0.53%)  0/377 (0.00%) 
Hemiparesis  1  1/377 (0.27%)  0/377 (0.00%) 
Hepatic encephalopathy  1  2/377 (0.53%)  1/377 (0.27%) 
Hydrocephalus  1  1/377 (0.27%)  0/377 (0.00%) 
Hypertensive encephalopathy  1  1/377 (0.27%)  0/377 (0.00%) 
Hypoxic-ischaemic encephalopathy  1  0/377 (0.00%)  1/377 (0.27%) 
Metabolic encephalopathy  1  1/377 (0.27%)  1/377 (0.27%) 
Migraine  1  0/377 (0.00%)  1/377 (0.27%) 
Paraesthesia  1  0/377 (0.00%)  1/377 (0.27%) 
Partial seizures  1  1/377 (0.27%)  0/377 (0.00%) 
Presyncope  1  1/377 (0.27%)  0/377 (0.00%) 
Seizure  1  2/377 (0.53%)  0/377 (0.00%) 
Syncope  1  5/377 (1.33%)  6/377 (1.59%) 
Transient ischaemic attack  1  0/377 (0.00%)  2/377 (0.53%) 
Unresponsive to stimuli  1  1/377 (0.27%)  0/377 (0.00%) 
Product Issues     
Device leakage  1  0/377 (0.00%)  1/377 (0.27%) 
Device malfunction  1  0/377 (0.00%)  1/377 (0.27%) 
Psychiatric disorders     
Anxiety  1  0/377 (0.00%)  1/377 (0.27%) 
Delirium  1  1/377 (0.27%)  0/377 (0.00%) 
Depression  1  2/377 (0.53%)  2/377 (0.53%) 
Drug abuse  1  0/377 (0.00%)  1/377 (0.27%) 
Mental status changes  1  2/377 (0.53%)  2/377 (0.53%) 
Renal and urinary disorders     
Acute kidney injury  1  34/377 (9.02%)  24/377 (6.37%) 
Azotaemia  1  1/377 (0.27%)  3/377 (0.80%) 
Chronic kidney disease  1  5/377 (1.33%)  4/377 (1.06%) 
End stage renal disease  1  12/377 (3.18%)  6/377 (1.59%) 
Hydronephrosis  1  1/377 (0.27%)  0/377 (0.00%) 
Nephropathy  1  1/377 (0.27%)  0/377 (0.00%) 
Renal failure  1  7/377 (1.86%)  5/377 (1.33%) 
Renal impairment  1  2/377 (0.53%)  0/377 (0.00%) 
Renal mass  1  0/377 (0.00%)  1/377 (0.27%) 
Renal tubular necrosis  1  1/377 (0.27%)  1/377 (0.27%) 
Reproductive system and breast disorders     
Benign prostatic hyperplasia  1  0/377 (0.00%)  1/377 (0.27%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory failure  1  5/377 (1.33%)  3/377 (0.80%) 
Asthma  1  0/377 (0.00%)  2/377 (0.53%) 
Atelectasis  1  0/377 (0.00%)  1/377 (0.27%) 
Chronic obstructive pulmonary disease  1  7/377 (1.86%)  3/377 (0.80%) 
Dyspnoea  1  3/377 (0.80%)  7/377 (1.86%) 
Dyspnoea exertional  1  0/377 (0.00%)  1/377 (0.27%) 
Epistaxis  1  1/377 (0.27%)  0/377 (0.00%) 
Hypercapnia  1  1/377 (0.27%)  0/377 (0.00%) 
Interstitial lung disease  1  1/377 (0.27%)  0/377 (0.00%) 
Oropharyngeal pain  1  1/377 (0.27%)  0/377 (0.00%) 
Pickwickian syndrome  1  1/377 (0.27%)  0/377 (0.00%) 
Pleural effusion  1  3/377 (0.80%)  6/377 (1.59%) 
Pleural fibrosis  1  1/377 (0.27%)  0/377 (0.00%) 
Pneumonia aspiration  1  0/377 (0.00%)  1/377 (0.27%) 
Pneumothorax  1  0/377 (0.00%)  1/377 (0.27%) 
Pulmonary congestion  1  2/377 (0.53%)  0/377 (0.00%) 
Pulmonary embolism  1  0/377 (0.00%)  1/377 (0.27%) 
Pulmonary oedema  1  4/377 (1.06%)  4/377 (1.06%) 
Respiratory arrest  1  1/377 (0.27%)  0/377 (0.00%) 
Respiratory disorder  1  1/377 (0.27%)  0/377 (0.00%) 
Respiratory distress  1  0/377 (0.00%)  1/377 (0.27%) 
Respiratory failure  1  6/377 (1.59%)  4/377 (1.06%) 
Sinus congestion  1  1/377 (0.27%)  0/377 (0.00%) 
Skin and subcutaneous tissue disorders     
Diabetic foot  1  1/377 (0.27%)  1/377 (0.27%) 
Eczema  1  1/377 (0.27%)  0/377 (0.00%) 
Rash erythematous  1  1/377 (0.27%)  0/377 (0.00%) 
Surgical and medical procedures     
Dialysis  1  0/377 (0.00%)  1/377 (0.27%) 
Vascular disorders     
Accelerated hypertension  1  0/377 (0.00%)  1/377 (0.27%) 
Aneurysm  1  0/377 (0.00%)  1/377 (0.27%) 
Aortic aneurysm  1  1/377 (0.27%)  1/377 (0.27%) 
Aortic stenosis  1  0/377 (0.00%)  1/377 (0.27%) 
Deep vein thrombosis  1  3/377 (0.80%)  2/377 (0.53%) 
Diastolic hypertension  1  0/377 (0.00%)  1/377 (0.27%) 
Embolism  1  1/377 (0.27%)  1/377 (0.27%) 
Hypertension  1  6/377 (1.59%)  3/377 (0.80%) 
Hypertensive crisis  1  4/377 (1.06%)  2/377 (0.53%) 
Hypertensive emergency  1  0/377 (0.00%)  1/377 (0.27%) 
Hypotension  1  4/377 (1.06%)  4/377 (1.06%) 
Intermittent claudication  1  0/377 (0.00%)  1/377 (0.27%) 
Malignant hypertension  1  0/377 (0.00%)  1/377 (0.27%) 
Orthostatic hypotension  1  1/377 (0.27%)  0/377 (0.00%) 
Peripheral arterial occlusive disease  1  1/377 (0.27%)  2/377 (0.53%) 
Peripheral artery occlusion  1  0/377 (0.00%)  1/377 (0.27%) 
Thrombosis  1  1/377 (0.27%)  0/377 (0.00%) 
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Hb-Based Titration Group Fixed Dose Group
Affected / at Risk (%) Affected / at Risk (%)
Total   292/377 (77.45%)   300/377 (79.58%) 
Blood and lymphatic system disorders     
Anaemia  1  19/377 (5.04%)  36/377 (9.55%) 
Anaemia of chronic disease  1  0/377 (0.00%)  1/377 (0.27%) 
Hilar lymphadenopathy  1  1/377 (0.27%)  0/377 (0.00%) 
Iron deficiency anaemia  1  2/377 (0.53%)  4/377 (1.06%) 
Leukocytosis  1  3/377 (0.80%)  5/377 (1.33%) 
Lymphadenitis  1  1/377 (0.27%)  0/377 (0.00%) 
Microcytic anaemia  1  1/377 (0.27%)  0/377 (0.00%) 
Neutropenia  1  0/377 (0.00%)  1/377 (0.27%) 
Pancytopenia  1  1/377 (0.27%)  2/377 (0.53%) 
Pernicious anaemia  1  0/377 (0.00%)  1/377 (0.27%) 
Splenomegaly  1  1/377 (0.27%)  1/377 (0.27%) 
Thrombocytopenia  1  2/377 (0.53%)  6/377 (1.59%) 
Cardiac disorders     
Angina pectoris  1  2/377 (0.53%)  0/377 (0.00%) 
Angina unstable  1  0/377 (0.00%)  1/377 (0.27%) 
Aortic valve incompetence  1  0/377 (0.00%)  1/377 (0.27%) 
Aortic valve sclerosis  1  1/377 (0.27%)  1/377 (0.27%) 
Arrhythmia  1  0/377 (0.00%)  1/377 (0.27%) 
Arteriosclerosis coronary artery  1  0/377 (0.00%)  1/377 (0.27%) 
Atrial fibrillation  1  2/377 (0.53%)  4/377 (1.06%) 
Atrial flutter  1  1/377 (0.27%)  0/377 (0.00%) 
Atrioventricular block second degree  1  0/377 (0.00%)  1/377 (0.27%) 
Bradycardia  1  5/377 (1.33%)  4/377 (1.06%) 
Bundle branch block right  1  0/377 (0.00%)  1/377 (0.27%) 
Cardiac failure  1  4/377 (1.06%)  6/377 (1.59%) 
Cardiac failure acute  1  1/377 (0.27%)  2/377 (0.53%) 
Cardiac failure congestive  1  3/377 (0.80%)  5/377 (1.33%) 
Cardiomegaly  1  2/377 (0.53%)  7/377 (1.86%) 
Cardiomyopathy  1  1/377 (0.27%)  1/377 (0.27%) 
Coronary artery disease  1  1/377 (0.27%)  1/377 (0.27%) 
Diastolic dysfunction  1  2/377 (0.53%)  0/377 (0.00%) 
Dilatation atrial  1  0/377 (0.00%)  1/377 (0.27%) 
Ischaemic cardiomyopathy  1  0/377 (0.00%)  1/377 (0.27%) 
Left ventricular dilatation  1  0/377 (0.00%)  1/377 (0.27%) 
Left ventricular failure  1  0/377 (0.00%)  1/377 (0.27%) 
Mitral valve calcification  1  0/377 (0.00%)  1/377 (0.27%) 
Mitral valve incompetence  1  1/377 (0.27%)  1/377 (0.27%) 
Myocardial infarction  1  3/377 (0.80%)  0/377 (0.00%) 
Myocardial ischaemia  1  0/377 (0.00%)  1/377 (0.27%) 
Palpitations  1  1/377 (0.27%)  3/377 (0.80%) 
Pulmonary valve incompetence  1  1/377 (0.27%)  1/377 (0.27%) 
Tachycardia  1  1/377 (0.27%)  1/377 (0.27%) 
Tricuspid valve incompetence  1  1/377 (0.27%)  2/377 (0.53%) 
Congenital, familial and genetic disorders     
Pyloric stenosis  1  0/377 (0.00%)  1/377 (0.27%) 
Vascular malformation  1  0/377 (0.00%)  1/377 (0.27%) 
Ear and labyrinth disorders     
Cerumen impaction  1  1/377 (0.27%)  1/377 (0.27%) 
Ear discomfort  1  0/377 (0.00%)  1/377 (0.27%) 
Ear pain  1  0/377 (0.00%)  2/377 (0.53%) 
Hypoacusis  1  0/377 (0.00%)  3/377 (0.80%) 
Vertigo  1  4/377 (1.06%)  5/377 (1.33%) 
Endocrine disorders     
Adrenal mass  1  1/377 (0.27%)  0/377 (0.00%) 
Hyperadrenalism  1  0/377 (0.00%)  1/377 (0.27%) 
Hyperparathyroidism  1  2/377 (0.53%)  1/377 (0.27%) 
Hyperparathyroidism secondary  1  3/377 (0.80%)  3/377 (0.80%) 
Hypothyroidism  1  3/377 (0.80%)  5/377 (1.33%) 
Secondary hyperthyroidism  1  1/377 (0.27%)  0/377 (0.00%) 
Eye disorders     
Astigmatism  1  1/377 (0.27%)  0/377 (0.00%) 
Blepharitis  1  1/377 (0.27%)  0/377 (0.00%) 
Blindness unilateral  1  0/377 (0.00%)  1/377 (0.27%) 
Cataract  1  6/377 (1.59%)  4/377 (1.06%) 
Cataract cortical  1  1/377 (0.27%)  0/377 (0.00%) 
Cataract nuclear  1  1/377 (0.27%)  0/377 (0.00%) 
Conjunctival haemorrhage  1  1/377 (0.27%)  1/377 (0.27%) 
Diabetic retinal oedema  1  1/377 (0.27%)  0/377 (0.00%) 
Diabetic retinopathy  1  1/377 (0.27%)  2/377 (0.53%) 
Dry eye  1  1/377 (0.27%)  3/377 (0.80%) 
Eye allergy  1  1/377 (0.27%)  0/377 (0.00%) 
Eye haemorrhage  1  1/377 (0.27%)  1/377 (0.27%) 
Glaucoma  1  1/377 (0.27%)  2/377 (0.53%) 
Hypermetropia  1  1/377 (0.27%)  0/377 (0.00%) 
Iritis  1  0/377 (0.00%)  1/377 (0.27%) 
Lacrimation increased  1  0/377 (0.00%)  1/377 (0.27%) 
Macular degeneration  1  1/377 (0.27%)  0/377 (0.00%) 
Ophthalmoplegia  1  0/377 (0.00%)  1/377 (0.27%) 
Presbyopia  1  1/377 (0.27%)  0/377 (0.00%) 
Retinal detachment  1  1/377 (0.27%)  0/377 (0.00%) 
Retinal haemorrhage  1  0/377 (0.00%)  1/377 (0.27%) 
Retinal tear  1  1/377 (0.27%)  0/377 (0.00%) 
Retinopathy  1  0/377 (0.00%)  1/377 (0.27%) 
Vision blurred  1  1/377 (0.27%)  1/377 (0.27%) 
Vitreous haemorrhage  1  1/377 (0.27%)  3/377 (0.80%) 
Gastrointestinal disorders     
Abdominal discomfort  1  2/377 (0.53%)  0/377 (0.00%) 
Abdominal distension  1  1/377 (0.27%)  2/377 (0.53%) 
Abdominal hernia  1  2/377 (0.53%)  0/377 (0.00%) 
Abdominal pain  1  6/377 (1.59%)  6/377 (1.59%) 
Abdominal pain lower  1  1/377 (0.27%)  0/377 (0.00%) 
Abdominal pain upper  1  6/377 (1.59%)  1/377 (0.27%) 
Anal fissure  1  1/377 (0.27%)  0/377 (0.00%) 
Ascites  1  1/377 (0.27%)  0/377 (0.00%) 
Change of bowel habit  1  0/377 (0.00%)  1/377 (0.27%) 
Constipation  1  11/377 (2.92%)  17/377 (4.51%) 
Dental caries  1  1/377 (0.27%)  2/377 (0.53%) 
Diabetic gastroparesis  1  0/377 (0.00%)  1/377 (0.27%) 
Diarrhoea  1  22/377 (5.84%)  19/377 (5.04%) 
Diverticulum  1  0/377 (0.00%)  1/377 (0.27%) 
Diverticulum intestinal  1  1/377 (0.27%)  2/377 (0.53%) 
Dry mouth  1  1/377 (0.27%)  1/377 (0.27%) 
Dyspepsia  1  1/377 (0.27%)  3/377 (0.80%) 
Dysphagia  1  3/377 (0.80%)  3/377 (0.80%) 
Flatulence  1  1/377 (0.27%)  1/377 (0.27%) 
Food poisoning  1  0/377 (0.00%)  1/377 (0.27%) 
Gastric ulcer  1  0/377 (0.00%)  1/377 (0.27%) 
Gastritis  1  3/377 (0.80%)  7/377 (1.86%) 
Gastritis erosive  1  1/377 (0.27%)  0/377 (0.00%) 
Gastrointestinal haemorrhage  1  1/377 (0.27%)  3/377 (0.80%) 
Gastrooesophageal reflux disease  1  6/377 (1.59%)  8/377 (2.12%) 
Gingival bleeding  1  1/377 (0.27%)  0/377 (0.00%) 
Haematemesis  1  0/377 (0.00%)  1/377 (0.27%) 
Haematochezia  1  0/377 (0.00%)  1/377 (0.27%) 
Haemorrhoidal haemorrhage  1  0/377 (0.00%)  1/377 (0.27%) 
Haemorrhoids  1  2/377 (0.53%)  3/377 (0.80%) 
Hiatus hernia  1  2/377 (0.53%)  4/377 (1.06%) 
Hyperchlorhydria  1  1/377 (0.27%)  0/377 (0.00%) 
Impaired gastric emptying  1  0/377 (0.00%)  1/377 (0.27%) 
Inguinal hernia  1  1/377 (0.27%)  2/377 (0.53%) 
Large intestine polyp  1  1/377 (0.27%)  2/377 (0.53%) 
Lip swelling  1  1/377 (0.27%)  0/377 (0.00%) 
Nausea  1  27/377 (7.16%)  22/377 (5.84%) 
Oesophageal food impaction  1  0/377 (0.00%)  1/377 (0.27%) 
Oesophagitis  1  0/377 (0.00%)  1/377 (0.27%) 
Parotid gland enlargement  1  1/377 (0.27%)  0/377 (0.00%) 
Rectal haemorrhage  1  1/377 (0.27%)  4/377 (1.06%) 
Toothache  1  3/377 (0.80%)  4/377 (1.06%) 
Umbilical hernia  1  0/377 (0.00%)  1/377 (0.27%) 
Vomiting  1  17/377 (4.51%)  12/377 (3.18%) 
General disorders     
Asthenia  1  17/377 (4.51%)  15/377 (3.98%) 
Chest discomfort  1  3/377 (0.80%)  0/377 (0.00%) 
Chest pain  1  8/377 (2.12%)  10/377 (2.65%) 
Chills  1  5/377 (1.33%)  2/377 (0.53%) 
Cyst  1  0/377 (0.00%)  1/377 (0.27%) 
Drug intolerance  1  0/377 (0.00%)  1/377 (0.27%) 
Fatigue  1  17/377 (4.51%)  21/377 (5.57%) 
Feeling cold  1  1/377 (0.27%)  0/377 (0.00%) 
Gait disturbance  1  0/377 (0.00%)  1/377 (0.27%) 
Generalised oedema  1  1/377 (0.27%)  0/377 (0.00%) 
Hypothermia  1  1/377 (0.27%)  1/377 (0.27%) 
Influenza like illness  1  3/377 (0.80%)  3/377 (0.80%) 
Injection site oedema  1  1/377 (0.27%)  0/377 (0.00%) 
Injection site pain  1  1/377 (0.27%)  1/377 (0.27%) 
Localised oedema  1  0/377 (0.00%)  1/377 (0.27%) 
Malaise  1  1/377 (0.27%)  2/377 (0.53%) 
Nodule  1  1/377 (0.27%)  0/377 (0.00%) 
Non-cardiac chest pain  1  2/377 (0.53%)  2/377 (0.53%) 
Oedema  1  17/377 (4.51%)  18/377 (4.77%) 
Oedema peripheral  1  35/377 (9.28%)  29/377 (7.69%) 
Pain  1  5/377 (1.33%)  4/377 (1.06%) 
Peripheral swelling  1  8/377 (2.12%)  9/377 (2.39%) 
Polyp  1  2/377 (0.53%)  0/377 (0.00%) 
Pyrexia  1  6/377 (1.59%)  4/377 (1.06%) 
Sluggishness  1  0/377 (0.00%)  1/377 (0.27%) 
Swelling  1  1/377 (0.27%)  1/377 (0.27%) 
Systemic inflammatory response syndrome  1  0/377 (0.00%)  1/377 (0.27%) 
Temperature intolerance  1  0/377 (0.00%)  1/377 (0.27%) 
Thirst  1  2/377 (0.53%)  0/377 (0.00%) 
Vaccination site bruising  1  0/377 (0.00%)  1/377 (0.27%) 
Hepatobiliary disorders     
Autoimmune hepatitis  1  0/377 (0.00%)  1/377 (0.27%) 
Biliary tract disorder  1  0/377 (0.00%)  1/377 (0.27%) 
Cholecystitis acute  1  0/377 (0.00%)  1/377 (0.27%) 
Cholelithiasis  1  2/377 (0.53%)  3/377 (0.80%) 
Hepatic cirrhosis  1  1/377 (0.27%)  1/377 (0.27%) 
Immune system disorders     
Drug hypersensitivity  1  1/377 (0.27%)  0/377 (0.00%) 
Food allergy  1  0/377 (0.00%)  1/377 (0.27%) 
Hypersensitivity  1  1/377 (0.27%)  2/377 (0.53%) 
Seasonal allergy  1  2/377 (0.53%)  3/377 (0.80%) 
Infections and infestations     
Abdominal abscess  1  1/377 (0.27%)  0/377 (0.00%) 
Abscess  1  0/377 (0.00%)  2/377 (0.53%) 
Abscess limb  1  1/377 (0.27%)  1/377 (0.27%) 
Abscess neck  1  1/377 (0.27%)  0/377 (0.00%) 
Abscess oral  1  0/377 (0.00%)  1/377 (0.27%) 
Acute sinusitis  1  5/377 (1.33%)  2/377 (0.53%) 
Appendicitis perforated  1  1/377 (0.27%)  0/377 (0.00%) 
Bacteraemia  1  1/377 (0.27%)  0/377 (0.00%) 
Bacteriuria  1  1/377 (0.27%)  1/377 (0.27%) 
Blister infected  1  1/377 (0.27%)  0/377 (0.00%) 
Body tinea  1  0/377 (0.00%)  2/377 (0.53%) 
Bronchitis  1  19/377 (5.04%)  15/377 (3.98%) 
Candida infection  1  1/377 (0.27%)  0/377 (0.00%) 
Cellulitis  1  8/377 (2.12%)  9/377 (2.39%) 
Chikungunya virus infection  1  1/377 (0.27%)  0/377 (0.00%) 
Chronic sinusitis  1  0/377 (0.00%)  1/377 (0.27%) 
Clostridium difficile colitis  1  0/377 (0.00%)  1/377 (0.27%) 
Coccidioidomycosis  1  1/377 (0.27%)  0/377 (0.00%) 
Conjunctivitis  1  1/377 (0.27%)  2/377 (0.53%) 
Conjunctivitis bacterial  1  1/377 (0.27%)  1/377 (0.27%) 
Cystitis  1  2/377 (0.53%)  4/377 (1.06%) 
Diabetic foot infection  1  1/377 (0.27%)  0/377 (0.00%) 
Diverticulitis  1  0/377 (0.00%)  2/377 (0.53%) 
Ear infection  1  0/377 (0.00%)  1/377 (0.27%) 
Enterococcal bacteraemia  1  1/377 (0.27%)  0/377 (0.00%) 
Escherichia urinary tract infection  1  0/377 (0.00%)  1/377 (0.27%) 
Eye infection  1  1/377 (0.27%)  1/377 (0.27%) 
Fungal skin infection  1  4/377 (1.06%)  2/377 (0.53%) 
Furuncle  1  1/377 (0.27%)  2/377 (0.53%) 
Gastric ulcer helicobacter  1  1/377 (0.27%)  0/377 (0.00%) 
Gastroenteritis  1  3/377 (0.80%)  1/377 (0.27%) 
Gastroenteritis viral  1  2/377 (0.53%)  3/377 (0.80%) 
Genital candidiasis  1  1/377 (0.27%)  0/377 (0.00%) 
Gingivitis  1  1/377 (0.27%)  0/377 (0.00%) 
Helicobacter gastritis  1  1/377 (0.27%)  0/377 (0.00%) 
Helicobacter infection  1  0/377 (0.00%)  2/377 (0.53%) 
Herpes virus infection  1  1/377 (0.27%)  0/377 (0.00%) 
Herpes zoster  1  6/377 (1.59%)  5/377 (1.33%) 
Infected cyst  1  1/377 (0.27%)  0/377 (0.00%) 
Influenza  1  4/377 (1.06%)  5/377 (1.33%) 
Laryngitis  1  1/377 (0.27%)  1/377 (0.27%) 
Localised infection  1  3/377 (0.80%)  1/377 (0.27%) 
Lower respiratory tract infection  1  0/377 (0.00%)  1/377 (0.27%) 
Lung infection  1  3/377 (0.80%)  0/377 (0.00%) 
Mastoiditis  1  1/377 (0.27%)  0/377 (0.00%) 
Nail infection  1  0/377 (0.00%)  1/377 (0.27%) 
Nasopharyngitis  1  8/377 (2.12%)  16/377 (4.24%) 
Oesophageal candidiasis  1  1/377 (0.27%)  0/377 (0.00%) 
Onychomycosis  1  1/377 (0.27%)  0/377 (0.00%) 
Oral candidiasis  1  2/377 (0.53%)  1/377 (0.27%) 
Osteomyelitis  1  1/377 (0.27%)  0/377 (0.00%) 
Otitis externa  1  2/377 (0.53%)  0/377 (0.00%) 
Otitis media acute  1  1/377 (0.27%)  0/377 (0.00%) 
Paronychia  1  2/377 (0.53%)  0/377 (0.00%) 
Periorbital abscess  1  1/377 (0.27%)  0/377 (0.00%) 
Pharyngitis  1  1/377 (0.27%)  3/377 (0.80%) 
Pharyngitis streptococcal  1  1/377 (0.27%)  0/377 (0.00%) 
Pneumonia  1  5/377 (1.33%)  5/377 (1.33%) 
Pneumonia bacterial  1  1/377 (0.27%)  0/377 (0.00%) 
Postoperative wound infection  1  0/377 (0.00%)  1/377 (0.27%) 
Pulmonary sepsis  1  0/377 (0.00%)  1/377 (0.27%) 
Pyelonephritis  1  0/377 (0.00%)  1/377 (0.27%) 
Pyoderma  1  0/377 (0.00%)  1/377 (0.27%) 
Pyuria  1  2/377 (0.53%)  0/377 (0.00%) 
Rhinitis  1  0/377 (0.00%)  1/377 (0.27%) 
Sebaceous gland infection  1  0/377 (0.00%)  1/377 (0.27%) 
Sinusitis  1  6/377 (1.59%)  6/377 (1.59%) 
Sinusitis bacterial  1  2/377 (0.53%)  0/377 (0.00%) 
Skin infection  1  2/377 (0.53%)  1/377 (0.27%) 
Staphylococcal bacteraemia  1  1/377 (0.27%)  0/377 (0.00%) 
Subcutaneous abscess  1  1/377 (0.27%)  1/377 (0.27%) 
Tooth abscess  1  2/377 (0.53%)  4/377 (1.06%) 
Tooth infection  1  1/377 (0.27%)  3/377 (0.80%) 
Trichomoniasis  1  1/377 (0.27%)  1/377 (0.27%) 
Upper respiratory tract infection  1  19/377 (5.04%)  26/377 (6.90%) 
Urinary tract infection  1  38/377 (10.08%)  35/377 (9.28%) 
Urinary tract infection bacterial  1  1/377 (0.27%)  3/377 (0.80%) 
Urinary tract infection enterococcal  1  0/377 (0.00%)  1/377 (0.27%) 
Urinary tract infection pseudomonal  1  1/377 (0.27%)  0/377 (0.00%) 
Viral diarrhoea  1  1/377 (0.27%)  0/377 (0.00%) 
Viral infection  1  2/377 (0.53%)  1/377 (0.27%) 
Viral rhinitis  1  1/377 (0.27%)  0/377 (0.00%) 
Viral upper respiratory tract infection  1  0/377 (0.00%)  1/377 (0.27%) 
Vulvovaginitis  1  0/377 (0.00%)  1/377 (0.27%) 
Wound infection  1  1/377 (0.27%)  1/377 (0.27%) 
Wound infection staphylococcal  1  1/377 (0.27%)  0/377 (0.00%) 
Injury, poisoning and procedural complications     
Animal scratch  1  0/377 (0.00%)  1/377 (0.27%) 
Ankle fracture  1  1/377 (0.27%)  1/377 (0.27%) 
Arteriovenous fistula site complication  1  1/377 (0.27%)  0/377 (0.00%) 
Arthropod bite  1  1/377 (0.27%)  2/377 (0.53%) 
Back injury  1  0/377 (0.00%)  1/377 (0.27%) 
Burns second degree  1  0/377 (0.00%)  1/377 (0.27%) 
Chest injury  1  1/377 (0.27%)  2/377 (0.53%) 
Clavicle fracture  1  0/377 (0.00%)  1/377 (0.27%) 
Contusion  1  8/377 (2.12%)  16/377 (4.24%) 
Craniocerebral injury  1  1/377 (0.27%)  0/377 (0.00%) 
Exposure to toxic agent  1  1/377 (0.27%)  0/377 (0.00%) 
Eye contusion  1  0/377 (0.00%)  1/377 (0.27%) 
Fall  1  26/377 (6.90%)  22/377 (5.84%) 
Foot fracture  1  2/377 (0.53%)  1/377 (0.27%) 
Forearm fracture  1  1/377 (0.27%)  0/377 (0.00%) 
Foreign body  1  1/377 (0.27%)  0/377 (0.00%) 
Hand fracture  1  0/377 (0.00%)  1/377 (0.27%) 
Head injury  1  3/377 (0.80%)  0/377 (0.00%) 
Humerus fracture  1  1/377 (0.27%)  4/377 (1.06%) 
Incisional hernia  1  0/377 (0.00%)  1/377 (0.27%) 
Injury  1  0/377 (0.00%)  1/377 (0.27%) 
Intestinal anastomosis complication  1  0/377 (0.00%)  1/377 (0.27%) 
Joint dislocation  1  1/377 (0.27%)  0/377 (0.00%) 
Joint injury  1  0/377 (0.00%)  3/377 (0.80%) 
Laceration  1  6/377 (1.59%)  8/377 (2.12%) 
Ligament sprain  1  3/377 (0.80%)  2/377 (0.53%) 
Limb fracture  1  1/377 (0.27%)  0/377 (0.00%) 
Limb injury  1  0/377 (0.00%)  4/377 (1.06%) 
Lip injury  1  0/377 (0.00%)  1/377 (0.27%) 
Muscle strain  1  3/377 (0.80%)  3/377 (0.80%) 
Nail avulsion  1  0/377 (0.00%)  1/377 (0.27%) 
Post procedural haemorrhage  1  0/377 (0.00%)  1/377 (0.27%) 
Postoperative respiratory failure  1  0/377 (0.00%)  1/377 (0.27%) 
Procedural nausea  1  0/377 (0.00%)  1/377 (0.27%) 
Rib fracture  1  0/377 (0.00%)  2/377 (0.53%) 
Road traffic accident  1  2/377 (0.53%)  2/377 (0.53%) 
Skin abrasion  1  1/377 (0.27%)  3/377 (0.80%) 
Skin injury  1  0/377 (0.00%)  2/377 (0.53%) 
Soft tissue injury  1  1/377 (0.27%)  0/377 (0.00%) 
Spinal column injury  1  0/377 (0.00%)  1/377 (0.27%) 
Tendon rupture  1  1/377 (0.27%)  0/377 (0.00%) 
Thermal burn  1  0/377 (0.00%)  2/377 (0.53%) 
Tooth avulsion  1  1/377 (0.27%)  0/377 (0.00%) 
Traumatic haematoma  1  0/377 (0.00%)  1/377 (0.27%) 
Traumatic haemorrhage  1  1/377 (0.27%)  0/377 (0.00%) 
Vaccination complication  1  1/377 (0.27%)  0/377 (0.00%) 
Wound  1  4/377 (1.06%)  3/377 (0.80%) 
Wound dehiscence  1  0/377 (0.00%)  1/377 (0.27%) 
Wrist fracture  1  1/377 (0.27%)  1/377 (0.27%) 
Investigations     
Anticoagulation drug level above therapeutic  1  0/377 (0.00%)  1/377 (0.27%) 
Blood bicarbonate decreased  1  0/377 (0.00%)  1/377 (0.27%) 
Blood creatine increased  1  2/377 (0.53%)  0/377 (0.00%) 
Blood creatinine increased  1  1/377 (0.27%)  1/377 (0.27%) 
Blood glucose increased  1  1/377 (0.27%)  1/377 (0.27%) 
Blood iron decreased  1  1/377 (0.27%)  0/377 (0.00%) 
Blood parathyroid hormone increased  1  1/377 (0.27%)  0/377 (0.00%) 
Blood phosphorus increased  1  2/377 (0.53%)  0/377 (0.00%) 
Blood potassium abnormal  1  1/377 (0.27%)  0/377 (0.00%) 
Blood potassium increased  1  0/377 (0.00%)  1/377 (0.27%) 
Blood pressure abnormal  1  1/377 (0.27%)  0/377 (0.00%) 
Blood pressure diastolic  1  0/377 (0.00%)  1/377 (0.27%) 
Blood pressure diastolic increased  1  0/377 (0.00%)  1/377 (0.27%) 
Blood pressure increased  1  24/377 (6.37%)  16/377 (4.24%) 
Blood pressure systolic increased  1  1/377 (0.27%)  2/377 (0.53%) 
Carbon dioxide decreased  1  1/377 (0.27%)  0/377 (0.00%) 
Cardiac murmur  1  0/377 (0.00%)  1/377 (0.27%) 
Cardiac stress test abnormal  1  1/377 (0.27%)  0/377 (0.00%) 
Computerised tomogram abnormal  1  1/377 (0.27%)  0/377 (0.00%) 
Electrocardiogram T wave abnormal  1  0/377 (0.00%)  1/377 (0.27%) 
Endoscopy gastrointestinal normal  1  0/377 (0.00%)  1/377 (0.27%) 
Haemoglobin decreased  1  1/377 (0.27%)  1/377 (0.27%) 
Hepatic enzyme increased  1  1/377 (0.27%)  0/377 (0.00%) 
International normalised ratio increased  1  1/377 (0.27%)  0/377 (0.00%) 
Occult blood positive  1  0/377 (0.00%)  1/377 (0.27%) 
Prostatic specific antigen increased  1  0/377 (0.00%)  1/377 (0.27%) 
Protein total increased  1  0/377 (0.00%)  1/377 (0.27%) 
Serum ferritin decreased  1  1/377 (0.27%)  0/377 (0.00%) 
Thyroid function test abnormal  1  1/377 (0.27%)  0/377 (0.00%) 
Troponin increased  1  1/377 (0.27%)  1/377 (0.27%) 
Tuberculin test positive  1  0/377 (0.00%)  1/377 (0.27%) 
Urine output decreased  1  0/377 (0.00%)  1/377 (0.27%) 
Vitamin D decreased  1  0/377 (0.00%)  2/377 (0.53%) 
Weight decreased  1  3/377 (0.80%)  3/377 (0.80%) 
Weight increased  1  1/377 (0.27%)  1/377 (0.27%) 
Metabolism and nutrition disorders     
Abnormal loss of weight  1  1/377 (0.27%)  0/377 (0.00%) 
Acidosis  1  5/377 (1.33%)  2/377 (0.53%) 
Decreased appetite  1  7/377 (1.86%)  13/377 (3.45%) 
Dehydration  1  6/377 (1.59%)  7/377 (1.86%) 
Diabetes mellitus  1  2/377 (0.53%)  1/377 (0.27%) 
Diabetes mellitus inadequate control  1  1/377 (0.27%)  1/377 (0.27%) 
Diabetic ketoacidosis  1  0/377 (0.00%)  1/377 (0.27%) 
Dyslipidaemia  1  0/377 (0.00%)  1/377 (0.27%) 
Failure to thrive  1  0/377 (0.00%)  1/377 (0.27%) 
Fluid imbalance  1  0/377 (0.00%)  1/377 (0.27%) 
Fluid overload  1  5/377 (1.33%)  6/377 (1.59%) 
Gout  1  12/377 (3.18%)  10/377 (2.65%) 
Hypercalcaemia  1  0/377 (0.00%)  5/377 (1.33%) 
Hypercholesterolaemia  1  0/377 (0.00%)  1/377 (0.27%) 
Hyperglycaemia  1  8/377 (2.12%)  3/377 (0.80%) 
Hyperhomocysteinaemia  1  0/377 (0.00%)  1/377 (0.27%) 
Hyperkalaemia  1  18/377 (4.77%)  39/377 (10.34%) 
Hyperlipidaemia  1  1/377 (0.27%)  0/377 (0.00%) 
Hypernatraemia  1  1/377 (0.27%)  2/377 (0.53%) 
Hyperphosphataemia  1  7/377 (1.86%)  7/377 (1.86%) 
Hypervolaemia  1  1/377 (0.27%)  0/377 (0.00%) 
Hypoalbuminaemia  1  0/377 (0.00%)  1/377 (0.27%) 
Hypocalcaemia  1  3/377 (0.80%)  3/377 (0.80%) 
Hypoglycaemia  1  10/377 (2.65%)  11/377 (2.92%) 
Hypokalaemia  1  4/377 (1.06%)  6/377 (1.59%) 
Hyponatraemia  1  3/377 (0.80%)  4/377 (1.06%) 
Iron deficiency  1  4/377 (1.06%)  6/377 (1.59%) 
Iron overload  1  0/377 (0.00%)  1/377 (0.27%) 
Lactic acidosis  1  1/377 (0.27%)  0/377 (0.00%) 
Malnutrition  1  1/377 (0.27%)  1/377 (0.27%) 
Metabolic acidosis  1  6/377 (1.59%)  13/377 (3.45%) 
Metabolic alkalosis  1  0/377 (0.00%)  1/377 (0.27%) 
Pseudohyponatraemia  1  0/377 (0.00%)  1/377 (0.27%) 
Type 2 diabetes mellitus  1  1/377 (0.27%)  1/377 (0.27%) 
Vitamin B12 deficiency  1  2/377 (0.53%)  0/377 (0.00%) 
Vitamin D deficiency  1  5/377 (1.33%)  5/377 (1.33%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  17/377 (4.51%)  22/377 (5.84%) 
Arthritis  1  5/377 (1.33%)  3/377 (0.80%) 
Back pain  1  12/377 (3.18%)  21/377 (5.57%) 
Bone pain  1  1/377 (0.27%)  0/377 (0.00%) 
Bursitis  1  2/377 (0.53%)  1/377 (0.27%) 
CREST syndrome  1  1/377 (0.27%)  0/377 (0.00%) 
Cervical spinal stenosis  1  0/377 (0.00%)  1/377 (0.27%) 
Chronic kidney disease-mineral and bone disorder  1  1/377 (0.27%)  0/377 (0.00%) 
Costochondritis  1  1/377 (0.27%)  0/377 (0.00%) 
Enthesopathy  1  0/377 (0.00%)  1/377 (0.27%) 
Exostosis  1  2/377 (0.53%)  0/377 (0.00%) 
Flank pain  1  2/377 (0.53%)  7/377 (1.86%) 
Foot deformity  1  0/377 (0.00%)  1/377 (0.27%) 
Gouty arthritis  1  1/377 (0.27%)  1/377 (0.27%) 
Intervertebral disc degeneration  1  0/377 (0.00%)  1/377 (0.27%) 
Joint effusion  1  1/377 (0.27%)  1/377 (0.27%) 
Joint stiffness  1  0/377 (0.00%)  1/377 (0.27%) 
Joint swelling  1  2/377 (0.53%)  2/377 (0.53%) 
Limb mass  1  0/377 (0.00%)  1/377 (0.27%) 
Lumbar spinal stenosis  1  1/377 (0.27%)  0/377 (0.00%) 
Muscle spasms  1  7/377 (1.86%)  12/377 (3.18%) 
Muscular weakness  1  1/377 (0.27%)  3/377 (0.80%) 
Musculoskeletal chest pain  1  4/377 (1.06%)  2/377 (0.53%) 
Musculoskeletal pain  1  4/377 (1.06%)  7/377 (1.86%) 
Musculoskeletal stiffness  1  0/377 (0.00%)  4/377 (1.06%) 
Myalgia  1  2/377 (0.53%)  5/377 (1.33%) 
Myofascial pain syndrome  1  1/377 (0.27%)  0/377 (0.00%) 
Neck pain  1  3/377 (0.80%)  2/377 (0.53%) 
Neuropathic arthropathy  1  0/377 (0.00%)  1/377 (0.27%) 
Osteoarthritis  1  3/377 (0.80%)  5/377 (1.33%) 
Osteopenia  1  1/377 (0.27%)  1/377 (0.27%) 
Osteoporosis  1  0/377 (0.00%)  2/377 (0.53%) 
Pain in extremity  1  12/377 (3.18%)  12/377 (3.18%) 
Patellofemoral pain syndrome  1  0/377 (0.00%)  1/377 (0.27%) 
Plantar fasciitis  1  1/377 (0.27%)  3/377 (0.80%) 
Polymyositis  1  1/377 (0.27%)  0/377 (0.00%) 
Rhabdomyolysis  1  1/377 (0.27%)  0/377 (0.00%) 
Rotator cuff syndrome  1  2/377 (0.53%)  0/377 (0.00%) 
Spinal column stenosis  1  0/377 (0.00%)  1/377 (0.27%) 
Spinal osteoarthritis  1  1/377 (0.27%)  0/377 (0.00%) 
Synovial cyst  1  0/377 (0.00%)  2/377 (0.53%) 
Systemic lupus erythematosus  1  1/377 (0.27%)  1/377 (0.27%) 
Tendonitis  1  2/377 (0.53%)  0/377 (0.00%) 
Trigger finger  1  1/377 (0.27%)  0/377 (0.00%) 
Vertebral foraminal stenosis  1  0/377 (0.00%)  1/377 (0.27%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Acute myeloid leukaemia  1  0/377 (0.00%)  1/377 (0.27%) 
Adenoma benign  1  0/377 (0.00%)  1/377 (0.27%) 
Basal cell carcinoma  1  2/377 (0.53%)  4/377 (1.06%) 
Bladder cancer  1  0/377 (0.00%)  1/377 (0.27%) 
Bowen's disease  1  0/377 (0.00%)  2/377 (0.53%) 
Colon adenoma  1  0/377 (0.00%)  1/377 (0.27%) 
Haemangioma  1  0/377 (0.00%)  1/377 (0.27%) 
Large intestine benign neoplasm  1  0/377 (0.00%)  1/377 (0.27%) 
Lip squamous cell carcinoma  1  0/377 (0.00%)  1/377 (0.27%) 
Melanocytic naevus  1  1/377 (0.27%)  0/377 (0.00%) 
Myelodysplastic syndrome  1  0/377 (0.00%)  1/377 (0.27%) 
Neoplasm skin  1  0/377 (0.00%)  1/377 (0.27%) 
Plasma cell myeloma  1  1/377 (0.27%)  0/377 (0.00%) 
Prostate cancer  1  0/377 (0.00%)  1/377 (0.27%) 
Rectal cancer  1  0/377 (0.00%)  1/377 (0.27%) 
Renal haemangioma  1  1/377 (0.27%)  0/377 (0.00%) 
Seborrhoeic keratosis  1  1/377 (0.27%)  2/377 (0.53%) 
Small cell lung cancer  1  1/377 (0.27%)  0/377 (0.00%) 
Squamous cell carcinoma  1  1/377 (0.27%)  1/377 (0.27%) 
Squamous cell carcinoma of skin  1  1/377 (0.27%)  3/377 (0.80%) 
Thyroid cancer  1  0/377 (0.00%)  2/377 (0.53%) 
Uterine leiomyoma  1  1/377 (0.27%)  0/377 (0.00%) 
Nervous system disorders     
Altered state of consciousness  1  1/377 (0.27%)  0/377 (0.00%) 
Amnesia  1  0/377 (0.00%)  1/377 (0.27%) 
Aphasia  1  0/377 (0.00%)  1/377 (0.27%) 
Balance disorder  1  1/377 (0.27%)  1/377 (0.27%) 
Burning sensation  1  1/377 (0.27%)  0/377 (0.00%) 
Carpal tunnel syndrome  1  2/377 (0.53%)  0/377 (0.00%) 
Cerebral atrophy  1  1/377 (0.27%)  0/377 (0.00%) 
Cerebral small vessel ischaemic disease  1  1/377 (0.27%)  0/377 (0.00%) 
Cerebrovascular accident  1  0/377 (0.00%)  2/377 (0.53%) 
Dementia  1  1/377 (0.27%)  0/377 (0.00%) 
Diabetic neuropathy  1  3/377 (0.80%)  2/377 (0.53%) 
Disturbance in attention  1  0/377 (0.00%)  1/377 (0.27%) 
Dizziness  1  13/377 (3.45%)  28/377 (7.43%) 
Dizziness postural  1  1/377 (0.27%)  3/377 (0.80%) 
Dysarthria  1  2/377 (0.53%)  0/377 (0.00%) 
Dysgeusia  1  0/377 (0.00%)  1/377 (0.27%) 
Encephalopathy  1  0/377 (0.00%)  1/377 (0.27%) 
Headache  1  16/377 (4.24%)  14/377 (3.71%) 
Hyperaesthesia  1  0/377 (0.00%)  1/377 (0.27%) 
Hypoaesthesia  1  1/377 (0.27%)  6/377 (1.59%) 
IIIrd nerve paralysis  1  0/377 (0.00%)  1/377 (0.27%) 
Lethargy  1  1/377 (0.27%)  0/377 (0.00%) 
Memory impairment  1  0/377 (0.00%)  1/377 (0.27%) 
Migraine  1  1/377 (0.27%)  1/377 (0.27%) 
Migraine with aura  1  0/377 (0.00%)  1/377 (0.27%) 
Nerve compression  1  1/377 (0.27%)  0/377 (0.00%) 
Neuralgia  1  1/377 (0.27%)  0/377 (0.00%) 
Neuropathy peripheral  1  1/377 (0.27%)  2/377 (0.53%) 
Paraesthesia  1  1/377 (0.27%)  1/377 (0.27%) 
Polyneuropathy  1  1/377 (0.27%)  0/377 (0.00%) 
Presyncope  1  1/377 (0.27%)  2/377 (0.53%) 
Restless legs syndrome  1  0/377 (0.00%)  1/377 (0.27%) 
Sciatica  1  1/377 (0.27%)  3/377 (0.80%) 
Seizure  1  0/377 (0.00%)  1/377 (0.27%) 
Somnolence  1  2/377 (0.53%)  0/377 (0.00%) 
Syncope  1  3/377 (0.80%)  3/377 (0.80%) 
Tremor  1  1/377 (0.27%)  3/377 (0.80%) 
Psychiatric disorders     
Anxiety  1  7/377 (1.86%)  3/377 (0.80%) 
Confusional state  1  2/377 (0.53%)  0/377 (0.00%) 
Delirium  1  0/377 (0.00%)  2/377 (0.53%) 
Depressed mood  1  2/377 (0.53%)  2/377 (0.53%) 
Depression  1  5/377 (1.33%)  6/377 (1.59%) 
Hallucination  1  2/377 (0.53%)  0/377 (0.00%) 
Insomnia  1  6/377 (1.59%)  11/377 (2.92%) 
Mental status changes  1  2/377 (0.53%)  5/377 (1.33%) 
Paranoia  1  1/377 (0.27%)  0/377 (0.00%) 
Stress  1  0/377 (0.00%)  1/377 (0.27%) 
Renal and urinary disorders     
Acute kidney injury  1  10/377 (2.65%)  6/377 (1.59%) 
Anuria  1  1/377 (0.27%)  0/377 (0.00%) 
Azotaemia  1  3/377 (0.80%)  0/377 (0.00%) 
Bladder mass  1  0/377 (0.00%)  1/377 (0.27%) 
Bladder outlet obstruction  1  1/377 (0.27%)  0/377 (0.00%) 
Chronic kidney disease  1  9/377 (2.39%)  14/377 (3.71%) 
Dysuria  1  4/377 (1.06%)  5/377 (1.33%) 
End stage renal disease  1  4/377 (1.06%)  5/377 (1.33%) 
Haematuria  1  3/377 (0.80%)  2/377 (0.53%) 
Hydronephrosis  1  0/377 (0.00%)  2/377 (0.53%) 
Hypertonic bladder  1  0/377 (0.00%)  1/377 (0.27%) 
Microalbuminuria  1  0/377 (0.00%)  1/377 (0.27%) 
Nephrolithiasis  1  0/377 (0.00%)  1/377 (0.27%) 
Nephropathy  1  1/377 (0.27%)  2/377 (0.53%) 
Nocturia  1  0/377 (0.00%)  1/377 (0.27%) 
Pollakiuria  1  1/377 (0.27%)  1/377 (0.27%) 
Polyuria  1  3/377 (0.80%)  1/377 (0.27%) 
Proteinuria  1  0/377 (0.00%)  2/377 (0.53%) 
Renal atrophy  1  1/377 (0.27%)  0/377 (0.00%) 
Renal cyst  1  2/377 (0.53%)  2/377 (0.53%) 
Renal failure  1  1/377 (0.27%)  2/377 (0.53%) 
Renal impairment  1  2/377 (0.53%)  3/377 (0.80%) 
Renal mass  1  1/377 (0.27%)  0/377 (0.00%) 
Urethral stenosis  1  0/377 (0.00%)  1/377 (0.27%) 
Urinary incontinence  1  2/377 (0.53%)  1/377 (0.27%) 
Urinary retention  1  2/377 (0.53%)  1/377 (0.27%) 
Reproductive system and breast disorders     
Benign prostatic hyperplasia  1  0/377 (0.00%)  3/377 (0.80%) 
Breast mass  1  1/377 (0.27%)  0/377 (0.00%) 
Breast ulceration  1  0/377 (0.00%)  1/377 (0.27%) 
Cervical cyst  1  1/377 (0.27%)  0/377 (0.00%) 
Dysmenorrhoea  1  0/377 (0.00%)  1/377 (0.27%) 
Erectile dysfunction  1  0/377 (0.00%)  1/377 (0.27%) 
Menstruation irregular  1  1/377 (0.27%)  0/377 (0.00%) 
Ovarian cyst ruptured  1  0/377 (0.00%)  1/377 (0.27%) 
Sexual dysfunction  1  0/377 (0.00%)  1/377 (0.27%) 
Vaginal discharge  1  1/377 (0.27%)  0/377 (0.00%) 
Vaginal haemorrhage  1  1/377 (0.27%)  0/377 (0.00%) 
Vulvovaginal discomfort  1  1/377 (0.27%)  0/377 (0.00%) 
Vulvovaginal pruritus  1  1/377 (0.27%)  0/377 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory failure  1  1/377 (0.27%)  0/377 (0.00%) 
Allergic sinusitis  1  0/377 (0.00%)  1/377 (0.27%) 
Apnoea  1  0/377 (0.00%)  1/377 (0.27%) 
Asthma  1  2/377 (0.53%)  1/377 (0.27%) 
Atelectasis  1  0/377 (0.00%)  1/377 (0.27%) 
Bronchitis chronic  1  1/377 (0.27%)  0/377 (0.00%) 
Bronchospasm  1  1/377 (0.27%)  0/377 (0.00%) 
Chronic obstructive pulmonary disease  1  1/377 (0.27%)  3/377 (0.80%) 
Cough  1  17/377 (4.51%)  20/377 (5.31%) 
Dyspnoea  1  15/377 (3.98%)  21/377 (5.57%) 
Dyspnoea exertional  1  1/377 (0.27%)  5/377 (1.33%) 
Epistaxis  1  4/377 (1.06%)  4/377 (1.06%) 
Lung infiltration  1  0/377 (0.00%)  1/377 (0.27%) 
Nasal congestion  1  2/377 (0.53%)  4/377 (1.06%) 
Nasal polyps  1  1/377 (0.27%)  0/377 (0.00%) 
Oropharyngeal pain  1  7/377 (1.86%)  2/377 (0.53%) 
Paranasal sinus discomfort  1  0/377 (0.00%)  1/377 (0.27%) 
Pleural effusion  1  2/377 (0.53%)  7/377 (1.86%) 
Pneumonia aspiration  1  0/377 (0.00%)  1/377 (0.27%) 
Productive cough  1  1/377 (0.27%)  3/377 (0.80%) 
Pulmonary congestion  1  0/377 (0.00%)  1/377 (0.27%) 
Pulmonary fibrosis  1  1/377 (0.27%)  0/377 (0.00%) 
Pulmonary haemorrhage  1  1/377 (0.27%)  0/377 (0.00%) 
Pulmonary hypertension  1  0/377 (0.00%)  2/377 (0.53%) 
Pulmonary mass  1  2/377 (0.53%)  0/377 (0.00%) 
Pulmonary oedema  1  3/377 (0.80%)  3/377 (0.80%) 
Rales  1  0/377 (0.00%)  1/377 (0.27%) 
Respiratory failure  1  0/377 (0.00%)  1/377 (0.27%) 
Respiratory tract congestion  1  2/377 (0.53%)  1/377 (0.27%) 
Rhinitis allergic  1  1/377 (0.27%)  1/377 (0.27%) 
Rhinorrhoea  1  1/377 (0.27%)  2/377 (0.53%) 
Sinus congestion  1  5/377 (1.33%)  1/377 (0.27%) 
Sinus disorder  1  1/377 (0.27%)  0/377 (0.00%) 
Sleep apnoea syndrome  1  4/377 (1.06%)  0/377 (0.00%) 
Snoring  1  1/377 (0.27%)  0/377 (0.00%) 
Throat irritation  1  0/377 (0.00%)  1/377 (0.27%) 
Upper-airway cough syndrome  1  0/377 (0.00%)  1/377 (0.27%) 
Wheezing  1  1/377 (0.27%)  1/377 (0.27%) 
Skin and subcutaneous tissue disorders     
Actinic keratosis  1  0/377 (0.00%)  1/377 (0.27%) 
Alopecia  1  2/377 (0.53%)  0/377 (0.00%) 
Angioedema  1  1/377 (0.27%)  0/377 (0.00%) 
Blister  1  3/377 (0.80%)  1/377 (0.27%) 
Decubitus ulcer  1  1/377 (0.27%)  2/377 (0.53%) 
Dermal cyst  1  1/377 (0.27%)  0/377 (0.00%) 
Dermatitis  1  2/377 (0.53%)  3/377 (0.80%) 
Dermatitis contact  1  1/377 (0.27%)  1/377 (0.27%) 
Diabetic foot  1  0/377 (0.00%)  1/377 (0.27%) 
Drug reaction with eosinophilia and systemic symptoms  1  1/377 (0.27%)  0/377 (0.00%) 
Dry skin  1  0/377 (0.00%)  1/377 (0.27%) 
Ecchymosis  1  2/377 (0.53%)  4/377 (1.06%) 
Eczema  1  1/377 (0.27%)  0/377 (0.00%) 
Erythema multiforme  1  0/377 (0.00%)  1/377 (0.27%) 
Hair texture abnormal  1  0/377 (0.00%)  1/377 (0.27%) 
Ingrowing nail  1  1/377 (0.27%)  2/377 (0.53%) 
Lentigo  1  0/377 (0.00%)  2/377 (0.53%) 
Nail bed bleeding  1  0/377 (0.00%)  1/377 (0.27%) 
Night sweats  1  1/377 (0.27%)  0/377 (0.00%) 
Onychoclasis  1  1/377 (0.27%)  0/377 (0.00%) 
Petechiae  1  0/377 (0.00%)  1/377 (0.27%) 
Prurigo  1  0/377 (0.00%)  1/377 (0.27%) 
Pruritus  1  7/377 (1.86%)  7/377 (1.86%) 
Pruritus generalised  1  2/377 (0.53%)  6/377 (1.59%) 
Purpura senile  1  0/377 (0.00%)  1/377 (0.27%) 
Rash  1  8/377 (2.12%)  10/377 (2.65%) 
Rash generalised  1  2/377 (0.53%)  0/377 (0.00%) 
Rash maculo-papular  1  0/377 (0.00%)  1/377 (0.27%) 
Rash pruritic  1  2/377 (0.53%)  1/377 (0.27%) 
Skin discolouration  1  0/377 (0.00%)  1/377 (0.27%) 
Skin disorder  1  0/377 (0.00%)  1/377 (0.27%) 
Skin fissures  1  1/377 (0.27%)  0/377 (0.00%) 
Skin irritation  1  0/377 (0.00%)  1/377 (0.27%) 
Skin ulcer  1  2/377 (0.53%)  6/377 (1.59%) 
Stasis dermatitis  1  0/377 (0.00%)  2/377 (0.53%) 
Swelling face  1  1/377 (0.27%)  0/377 (0.00%) 
Urticaria  1  1/377 (0.27%)  1/377 (0.27%) 
Surgical and medical procedures     
Arteriovenous fistula operation  1  1/377 (0.27%)  2/377 (0.53%) 
Carpal tunnel decompression  1  1/377 (0.27%)  0/377 (0.00%) 
Cataract operation  1  2/377 (0.53%)  3/377 (0.80%) 
Catheter placement  1  0/377 (0.00%)  2/377 (0.53%) 
Knee arthroplasty  1  1/377 (0.27%)  0/377 (0.00%) 
Nephrostomy  1  1/377 (0.27%)  0/377 (0.00%) 
Sinus operation  1  1/377 (0.27%)  0/377 (0.00%) 
Toe operation  1  0/377 (0.00%)  1/377 (0.27%) 
Tooth extraction  1  3/377 (0.80%)  0/377 (0.00%) 
Vascular disorders     
Angiopathy  1  1/377 (0.27%)  0/377 (0.00%) 
Aortic aneurysm  1  0/377 (0.00%)  1/377 (0.27%) 
Arteriovenous fistula  1  0/377 (0.00%)  1/377 (0.27%) 
Blood pressure fluctuation  1  1/377 (0.27%)  0/377 (0.00%) 
Diastolic hypotension  1  0/377 (0.00%)  1/377 (0.27%) 
Haematoma  1  1/377 (0.27%)  2/377 (0.53%) 
Hypertension  1  46/377 (12.20%)  40/377 (10.61%) 
Hypertensive crisis  1  1/377 (0.27%)  0/377 (0.00%) 
Hypotension  1  6/377 (1.59%)  22/377 (5.84%) 
Intermittent claudication  1  1/377 (0.27%)  0/377 (0.00%) 
Orthostatic hypotension  1  1/377 (0.27%)  2/377 (0.53%) 
Peripheral arterial occlusive disease  1  1/377 (0.27%)  1/377 (0.27%) 
Peripheral vascular disorder  1  1/377 (0.27%)  0/377 (0.00%) 
Peripheral venous disease  1  1/377 (0.27%)  0/377 (0.00%) 
Thrombophlebitis superficial  1  1/377 (0.27%)  0/377 (0.00%) 
Varicose vein  1  1/377 (0.27%)  1/377 (0.27%) 
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
Results Point of Contact
Name/Title: Study Director
Organization: Amgen Inc.
Phone: 866-572-6436
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01652872     History of Changes
Other Study ID Numbers: 20110226
First Submitted: June 7, 2012
First Posted: July 30, 2012
Results First Submitted: October 11, 2018
Results First Posted: November 8, 2018
Last Update Posted: December 12, 2018