Trial Outcomes & Findings for Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA) (NCT NCT04322682)

Last Updated: 2024-12-13

Results Overview

The primary endpoint will be the composite of death or hospitalization due to COVID-19 infection in the 30 days following randomization.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

4506 participants

Primary outcome timeframe

30 days post randomization

Results posted on

2024-12-13

Participant Flow

18 patients were not included: * 11 study medication was not delivered at home; * 7 ineligible or condition deteriorated before study medication was delivered.

Participant milestones

Participant milestones
Measure	Colchicine Patients in this arm will receive study medication colchicine 0.5 mg per os (PO) twice daily for the first 3 days and then once daily for the last 27 days. If a dose is missed, it should not be replaced.	Placebo Patients will receive the placebo 0.5 mg per os (PO) twice daily for the first 3 days and then once daily for the last 27 days. If a dose is missed, it should not be replaced.
Overall Study STARTED	2235	2253
Overall Study COMPLETED	2192	2189
Overall Study NOT COMPLETED	43	64

Reasons for withdrawal

Reasons for withdrawal
Measure	Colchicine Patients in this arm will receive study medication colchicine 0.5 mg per os (PO) twice daily for the first 3 days and then once daily for the last 27 days. If a dose is missed, it should not be replaced.	Placebo Patients will receive the placebo 0.5 mg per os (PO) twice daily for the first 3 days and then once daily for the last 27 days. If a dose is missed, it should not be replaced.
Overall Study Withdrawal by Subject	33	47
Overall Study Death	5	9
Overall Study Lost to Follow-up	4	8
Overall Study Admitted to Hospital and Intubated	1	0

Baseline Characteristics

Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Colchicine n=2235 Participants Patients in this arm will receive study medication colchicine 0.5 mg per os (PO) twice daily for the first 3 days and then once daily for the last 27 days. If a dose is missed, it should not be replaced.	Placebo n=2253 Participants Patients will receive the placebo 0.5 mg per os (PO) twice daily for the first 3 days and then once daily for the last 27 days. If a dose is missed, it should not be replaced.	Total n=4488 Participants Total of all reporting groups
Age, Continuous	53.0 years n=5 Participants	54.0 years n=7 Participants	54.0 years n=5 Participants
Sex: Female, Male Female	1238 Participants n=5 Participants	1183 Participants n=7 Participants	2421 Participants n=5 Participants
Sex: Female, Male Male	997 Participants n=5 Participants	1070 Participants n=7 Participants	2067 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	327 Participants n=5 Participants	349 Participants n=7 Participants	676 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1869 Participants n=5 Participants	1872 Participants n=7 Participants	3741 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	39 Participants n=5 Participants	32 Participants n=7 Participants	71 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	5 Participants n=5 Participants	9 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) Asian	23 Participants n=5 Participants	20 Participants n=7 Participants	43 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) Black or African American	114 Participants n=5 Participants	116 Participants n=7 Participants	230 Participants n=5 Participants
Race (NIH/OMB) White	2084 Participants n=5 Participants	2092 Participants n=7 Participants	4176 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment Canada	1817 participants n=5 Participants	1830 participants n=7 Participants	3647 participants n=5 Participants
Region of Enrollment United States	244 participants n=5 Participants	244 participants n=7 Participants	488 participants n=5 Participants
Region of Enrollment South Africa	0 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants
Region of Enrollment Spain	94 participants n=5 Participants	94 participants n=7 Participants	188 participants n=5 Participants
Region of Enrollment Brazil	79 participants n=5 Participants	82 participants n=7 Participants	161 participants n=5 Participants
Region of Enrollment Greece	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants
History of Respiratory Disease Yes	583 Participants n=5 Participants	605 Participants n=7 Participants	1188 Participants n=5 Participants
History of Respiratory Disease No	1652 Participants n=5 Participants	1647 Participants n=7 Participants	3299 Participants n=5 Participants
History of Respiratory Disease Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
History of Diabetes Yes	444 Participants n=5 Participants	450 Participants n=7 Participants	894 Participants n=5 Participants
History of Diabetes No	1791 Participants n=5 Participants	1803 Participants n=7 Participants	3594 Participants n=5 Participants
Body Mass Index (BMI)	30.0 kg/m^2 STANDARD_DEVIATION 6.2 • n=5 Participants	30.0 kg/m^2 STANDARD_DEVIATION 6.3 • n=7 Participants	30.0 kg/m^2 STANDARD_DEVIATION 6.2 • n=5 Participants

PRIMARY outcome

Timeframe: 30 days post randomization

The primary endpoint will be the composite of death or hospitalization due to COVID-19 infection in the 30 days following randomization.

Outcome measures

Outcome measures
Measure	Colchicine n=2235 Participants Patients in this arm will receive study medication colchicine 0.5 mg per os (PO) twice daily for the first 3 days and then once daily for the last 27 days. If a dose is missed, it should not be replaced.	Placebo n=2253 Participants Patients will receive the placebo 0.5 mg per os (PO) twice daily for the first 3 days and then once daily for the last 27 days. If a dose is missed, it should not be replaced.
Number of Participants Who Died or Were Hospitalized Due to COVID-19 Infection in the 30 Days Following Randomization.	104 Participants	131 Participants

SECONDARY outcome

Timeframe: 30 days post randomization

The secondary endpoint consisted of two components of the composite primary endpoint and included death in the 30 days following randomization.

Outcome measures

Outcome measures
Measure	Colchicine n=2235 Participants Patients in this arm will receive study medication colchicine 0.5 mg per os (PO) twice daily for the first 3 days and then once daily for the last 27 days. If a dose is missed, it should not be replaced.	Placebo n=2253 Participants Patients will receive the placebo 0.5 mg per os (PO) twice daily for the first 3 days and then once daily for the last 27 days. If a dose is missed, it should not be replaced.
Number of Deaths in the 30 Days Following Randomization.	5 Participants	9 Participants

SECONDARY outcome

Timeframe: 30 days post randomization

The secondary endpoint consisted of two components of the composite primary endpoint and included hospitalization due to COVID-19 infection in the 30 days following randomization.

Outcome measures

Outcome measures
Measure	Colchicine n=2235 Participants Patients in this arm will receive study medication colchicine 0.5 mg per os (PO) twice daily for the first 3 days and then once daily for the last 27 days. If a dose is missed, it should not be replaced.	Placebo n=2253 Participants Patients will receive the placebo 0.5 mg per os (PO) twice daily for the first 3 days and then once daily for the last 27 days. If a dose is missed, it should not be replaced.
Number of Participants Who Were Hospitalized Due to COVID-19 Infection in the 30 Days Following Randomization.	101 Participants	128 Participants

SECONDARY outcome

Timeframe: 30 days post randomization

The secondary endpoint is the need for mechanical ventilation in the 30 days following randomization.

Outcome measures

Outcome measures
Measure	Colchicine n=2235 Participants Patients in this arm will receive study medication colchicine 0.5 mg per os (PO) twice daily for the first 3 days and then once daily for the last 27 days. If a dose is missed, it should not be replaced.	Placebo n=2253 Participants Patients will receive the placebo 0.5 mg per os (PO) twice daily for the first 3 days and then once daily for the last 27 days. If a dose is missed, it should not be replaced.
Number of Participants Who Required Mechanical Ventilation in the 30 Days Following Randomization.	11 Participants	21 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 30 Days post randomization

In the prespecified analysis of the 4159 patients with Covid-19 confirmed by PCR, the primary endpoint (composite of death or hospitalization due to Covid-19 infection in the 30 Days following randomization) was compared between the two treatment groups.

Outcome measures

Outcome measures
Measure	Colchicine n=2075 Participants Patients in this arm will receive study medication colchicine 0.5 mg per os (PO) twice daily for the first 3 days and then once daily for the last 27 days. If a dose is missed, it should not be replaced.	Placebo n=2084 Participants Patients will receive the placebo 0.5 mg per os (PO) twice daily for the first 3 days and then once daily for the last 27 days. If a dose is missed, it should not be replaced.
Number of Participants Who Died or Were Hospitalized Due to COVID-19 Infection in the 30 Days Following Randomization in the Subgroup of Patients With PCR-confirmed COVID-19.	96 Participants	126 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 30 Days post randomization

Population: Data were stratified by sex.

NIH-required analysis. The primary endpoint will be the composite of death or hospitalization due to COVID-19 infection in the 30 days following randomization by Sex.

Outcome measures

Outcome measures
Measure	Colchicine n=2235 Participants Patients in this arm will receive study medication colchicine 0.5 mg per os (PO) twice daily for the first 3 days and then once daily for the last 27 days. If a dose is missed, it should not be replaced.	Placebo n=2253 Participants Patients will receive the placebo 0.5 mg per os (PO) twice daily for the first 3 days and then once daily for the last 27 days. If a dose is missed, it should not be replaced.
Number of Participants Who Died or Were Hospitalized Due to COVID-19 Infection in the 30 Days Following Randomization by Sex Male	58 Participants	90 Participants
Number of Participants Who Died or Were Hospitalized Due to COVID-19 Infection in the 30 Days Following Randomization by Sex Female	46 Participants	41 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 30 Days post randomization

Population: Data were stratified by race.

NIH-required analysis. The primary endpoint will be the composite of death or hospitalization due to COVID-19 infection in the 30 days following randomization by Race.

Outcome measures

Outcome measures
Measure	Colchicine n=2235 Participants Patients in this arm will receive study medication colchicine 0.5 mg per os (PO) twice daily for the first 3 days and then once daily for the last 27 days. If a dose is missed, it should not be replaced.	Placebo n=2253 Participants Patients will receive the placebo 0.5 mg per os (PO) twice daily for the first 3 days and then once daily for the last 27 days. If a dose is missed, it should not be replaced.
Number of Participants Who Died or Were Hospitalized Due to COVID-19 Infection in the 30 Days Following Randomization by Race American Indian or Alaska Native	1 Participants	2 Participants
Number of Participants Who Died or Were Hospitalized Due to COVID-19 Infection in the 30 Days Following Randomization by Race Asian	1 Participants	3 Participants
Number of Participants Who Died or Were Hospitalized Due to COVID-19 Infection in the 30 Days Following Randomization by Race Black	3 Participants	6 Participants
Number of Participants Who Died or Were Hospitalized Due to COVID-19 Infection in the 30 Days Following Randomization by Race Native Hawaiian or other Pacific Islander	1 Participants	0 Participants
Number of Participants Who Died or Were Hospitalized Due to COVID-19 Infection in the 30 Days Following Randomization by Race White	98 Participants	120 Participants
Number of Participants Who Died or Were Hospitalized Due to COVID-19 Infection in the 30 Days Following Randomization by Race More than one race	0 Participants	0 Participants
Number of Participants Who Died or Were Hospitalized Due to COVID-19 Infection in the 30 Days Following Randomization by Race Not reported or unknown	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 30 Days post randomization

Population: Data were stratified by ethnicity.

NIH-required analysis. The primary endpoint will be the composite of death or hospitalization due to COVID-19 infection in the 30 days following randomization by Ethnicity.

Outcome measures

Outcome measures
Measure	Colchicine n=2235 Participants Patients in this arm will receive study medication colchicine 0.5 mg per os (PO) twice daily for the first 3 days and then once daily for the last 27 days. If a dose is missed, it should not be replaced.	Placebo n=2253 Participants Patients will receive the placebo 0.5 mg per os (PO) twice daily for the first 3 days and then once daily for the last 27 days. If a dose is missed, it should not be replaced.
Number of Participants Who Died or Were Hospitalized Due to COVID-19 Infection in the 30 Days Following Randomization by Ethnicity. Hispanic or Latino	20 Participants	24 Participants
Number of Participants Who Died or Were Hospitalized Due to COVID-19 Infection in the 30 Days Following Randomization by Ethnicity. Not Hispanic or Latino	82 Participants	106 Participants
Number of Participants Who Died or Were Hospitalized Due to COVID-19 Infection in the 30 Days Following Randomization by Ethnicity. Not reported or unknown	2 Participants	1 Participants

Adverse Events

Colchicine

Serious events: 108 serious events

Other events: 524 other events

Deaths: 5 deaths

Placebo

Serious events: 139 serious events

Other events: 328 other events

Deaths: 9 deaths

Serious adverse events

Other adverse events

Additional Information

Dr. Jean-Claude Tardif (Principle Investigator)

Montreal Heart Institute

Phone: 514 376-3330

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Colchicine n=2195 participants at risk Patients in this arm will receive study medication colchicine 0.5 mg per os (PO) twice daily for the first 3 days and then once daily for the last 27 days. If a dose is missed, it should not be replaced.	Placebo n=2217 participants at risk Patients will receive the placebo 0.5 mg per os (PO) twice daily for the first 3 days and then once daily for the last 27 days. If a dose is missed, it should not be replaced.
Cardiac disorders Arrhythmia	0.05% 1/2195 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.	0.00% 0/2217 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.
Gastrointestinal disorders Abdominal pain	0.05% 1/2195 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.	0.05% 1/2217 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.
General disorders Death	0.05% 1/2195 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.	0.05% 1/2217 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.
Immune system disorders Hypersensitivity	0.00% 0/2195 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.	0.05% 1/2217 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.
Infections and infestations Appendicitis	0.00% 0/2195 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.	0.05% 1/2217 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.
Investigations Blood magnesium abnormal	0.05% 1/2195 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.	0.00% 0/2217 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.
Metabolism and nutrition disorders Dehydration	0.14% 3/2195 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.	0.27% 6/2217 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.00% 0/2195 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.	0.05% 1/2217 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's lymphoma	0.00% 0/2195 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.	0.05% 1/2217 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.
Nervous system disorders Aphasia	0.00% 0/2195 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.	0.05% 1/2217 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.
Renal and urinary disorders Acute kidney injury	0.05% 1/2195 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.	0.05% 1/2217 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.
Respiratory, thoracic and mediastinal disorders Bronchitis	0.05% 1/2195 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.	0.00% 0/2217 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.
Vascular disorders Haemorrhage	0.05% 1/2195 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.	0.00% 0/2217 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.
Cardiac disorders Atrial fibrillation	0.05% 1/2195 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.	0.05% 1/2217 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.
Cardiac disorders Myocardial infarction	0.00% 0/2195 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.	0.05% 1/2217 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.
Cardiac disorders Pericarditis	0.00% 0/2195 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.	0.09% 2/2217 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.
Cardiac disorders Tachycardia	0.09% 2/2195 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.	0.05% 1/2217 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.
Gastrointestinal disorders Gastrointestinal disorder	0.14% 3/2195 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.	0.09% 2/2217 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.05% 1/2195 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.	0.00% 0/2217 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.
Gastrointestinal disorders Pancreatitis	0.05% 1/2195 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.	0.00% 0/2217 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.
General disorders General physical health deterioration	0.00% 0/2195 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.	0.05% 1/2217 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.
General disorders Pyrexia	0.00% 0/2195 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.	0.05% 1/2217 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.
Infections and infestations Corona virus infection	0.09% 2/2195 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.	0.00% 0/2217 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.
Infections and infestations Diverticulitis	0.05% 1/2195 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.	0.00% 0/2217 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.
Infections and infestations Pneumonia	2.9% 63/2195 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.	4.1% 92/2217 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.
Infections and infestations Pneumonia bacterial	0.18% 4/2195 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.	0.09% 2/2217 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.
Infections and infestations Pneumonia viral	0.09% 2/2195 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.	0.09% 2/2217 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.
Infections and infestations Pyelonephritis	0.05% 1/2195 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.	0.00% 0/2217 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.
Infections and infestations Septic shock	0.00% 0/2195 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.	0.05% 1/2217 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.
Infections and infestations Viral infection	0.00% 0/2195 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.	0.05% 1/2217 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.
Investigations Oxygen saturation decreased	0.00% 0/2195 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.	0.09% 2/2217 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.
Nervous system disorders Cerebrovascular accident	0.05% 1/2195 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.	0.00% 0/2217 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.
Nervous system disorders Dizziness	0.05% 1/2195 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.	0.00% 0/2217 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.
Nervous system disorders Headache	0.00% 0/2195 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.	0.14% 3/2217 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.
Nervous system disorders Loss of proprioception	0.00% 0/2195 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.	0.05% 1/2217 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.
Nervous system disorders Multiple sclerosis	0.00% 0/2195 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.	0.05% 1/2217 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.
Nervous system disorders Neuropathy peripheral	0.05% 1/2195 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.	0.00% 0/2217 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.
Nervous system disorders Syncope	0.00% 0/2195 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.	0.05% 1/2217 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.
Renal and urinary disorders Nephrolithiasis	0.05% 1/2195 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.	0.00% 0/2217 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.23% 5/2195 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.	0.18% 4/2217 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.

Other adverse events
Measure	Colchicine n=2195 participants at risk Patients in this arm will receive study medication colchicine 0.5 mg per os (PO) twice daily for the first 3 days and then once daily for the last 27 days. If a dose is missed, it should not be replaced.	Placebo n=2217 participants at risk Patients will receive the placebo 0.5 mg per os (PO) twice daily for the first 3 days and then once daily for the last 27 days. If a dose is missed, it should not be replaced.
Gastrointestinal disorders Abdominal discomfort	0.32% 7/2195 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.	0.14% 3/2217 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.
Gastrointestinal disorders Abdominal distension	0.05% 1/2195 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.	0.00% 0/2217 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.
Gastrointestinal disorders Abdominal pain	1.3% 28/2195 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.	0.81% 18/2217 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.
Gastrointestinal disorders Abdominal pain lower	0.05% 1/2195 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.	0.00% 0/2217 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.
Gastrointestinal disorders Constipation	0.09% 2/2195 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.	0.32% 7/2217 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.
Gastrointestinal disorders Diarrhoea	13.7% 300/2195 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.	7.3% 161/2217 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.
Gastrointestinal disorders Dry mouth	0.05% 1/2195 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.	0.00% 0/2217 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.
Gastrointestinal disorders Dyspepsia	0.36% 8/2195 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.	0.59% 13/2217 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.
Gastrointestinal disorders Epigastric discomfort	0.05% 1/2195 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.	0.09% 2/2217 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.
Gastrointestinal disorders Faeces soft	0.46% 10/2195 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.	0.09% 2/2217 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.
Gastrointestinal disorders Flatulence	0.05% 1/2195 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.	0.00% 0/2217 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.
Gastrointestinal disorders Gastric disorder	0.55% 12/2195 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.	0.36% 8/2217 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.
Gastrointestinal disorders Gastritis	0.05% 1/2195 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.	0.05% 1/2217 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.
Gastrointestinal disorders Gastrointestinal disorder	5.2% 114/2195 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.	3.2% 72/2217 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.05% 1/2195 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.	0.00% 0/2217 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.14% 3/2195 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.	0.09% 2/2217 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.
Gastrointestinal disorders Nausea	2.0% 43/2195 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.	2.1% 47/2217 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.
Gastrointestinal disorders Pancreatitis	0.05% 1/2195 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.	0.00% 0/2217 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.
Gastrointestinal disorders Vomiting	0.27% 6/2195 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.	0.18% 4/2217 • From randomization/baseline to End of Study visit which planned 30 days after baseline. 2 additional Serious Adverse Events were added to the definition : * cancer; * overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.